RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

Structure/Sequence

Molecular FormulaC31H35F3N6O7S2

InChIKeyLEVIGHXVOVROGW-UHFFFAOYSA-N

CAS Registry1421783-64-3

Clinical Trials associated with Olverembatinib

NCT06817720

/ Not yet recruitingPhase 2IIT

Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

To learn if olverembatinib can help to control newly diagnosed CML in the chronic phase.

Start Date30 Jul 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT06757855

/ Not yet recruitingPhase 1/2IIT

A Multicenter, Single-arm I/II Clinical Study of Olverembatinib Combined With Venetoclax and Azacitidine in in Blast Phase Ph Chromosome- Chronic Myeloid Leukemia

Even in the TKI era, the outcoms of patients with blast phase is still poor.The response rate to conventional intensive chemotherapy is only 12.5% and the 5-year survival rate is 0 for patients with myeloid blast crsis. The response rate of TKI monotherapy is about 50% and the response rate is further improved when combined TKI and chemotherapy for patients with lymphoid blast crsis. The induction remission rate of chemotherapy alone for patients with Ph-positive acute lymphoblastic leukemia is 50-60%, and the remission rate increases to more than 95% when combined with TKI. Therefore, the application of TKI for patients in the blast crisis phase is of great significance. Olverembatinib is the only third-generation TKI drug approved in the Chinese mainland at present. Preclinical research data show that olverembatinib has a significant inhibitory effect on wild-type and mutant ABL resistant to the first and second-generation TKIs, as well as some complex mutations resistant to ponatinib. Phase I and II clinical studies have shown that for CML patients in the chronic and accelerated phases with resistance or intolerance to various TKIs, with or without T315I mutations, there are significant hematological and molecular responses and survival benefits. Olverembatinib can also inhibit many other kinases related to tumors. In vitro studies have shown that olverembatinib downregulates MCL-1 expression and acts synergistically with BCL-2 inhibitors to induce apoptosis of AML cells.
Preclinical studies have shown that venetoclax has a synergistic effect with TKIs. It upregulates apoptosis-inducing proteins, downregulates anti-apoptotic protein MCL1, inhibits the anti-apoptotic activity of BCL-XL, induces apoptosis of Ph+ cells, overcomes TKI resistance, and eliminates CML leukemia stem cells.
A large amount of evidence indicates that DNA hypermethylation plays an important role in the progression of CML, and abnormal DNA methylation is associated with progression to the accelerated and blast crisis phases and resistance to TKIs.Domestic scholars have reported successful cases of combined treatment with TKI, venetoclax, and demethylating agent azacitidine for CML patients with lymphoid blast crisis.
Therefore, we designed this study to explore the efficacy and safety of olverembatinib, venetoclax, and azacitidine in the treatment of CML patients in the blast crisis phase.

Start Date15 Jan 2025

Sponsor / Collaborator

Hematology Hospital of Chinese Academy of Medical Sciences

ChiCTR2400094086

/ SuspendedPhase 1IIT

A clinical study of olverembatinib in combination with APG-1252 for the treatment of relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia or T-cell acute lymphoblastic lymphoma

Start Date01 Jan 2025

Sponsor / Collaborator-

100 Clinical Results associated with Olverembatinib

100 Translational Medicine associated with Olverembatinib

100 Patents (Medical) associated with Olverembatinib

Literatures (Medical) associated with Olverembatinib

01 Apr 2025·Clinical Lymphoma Myeloma & Leukemia

Tyrosine Kinase Inhibitor Treatment Patterns in Patients With Chronic-Phase Chronic Myeloid Leukemia: A Single Center Data From China

Article

Author: Jiang, Qian ; Yuan, Meng-Yao ; Zhang, Xiao-Shuai

AIM:

To describe tyrosine kinase inhibitor (TKI) treatment patterns and analyze co-variates of TKI switch for chronic myeloid leukemia (CML) patients in a center from China.

METHODS:

A retrospectively study was designed to analyze TKI switching patterns, reasons and associated covariates in patients with CP-CML.

RESULTS:

1766 patients receiving initial imatinib (n = 1374), nilotinib (n = 254), dasatinib (n = 63) and flumatinib (n = 75) therapy were retrospectively interrogated. Median follow-up was 48 (IQR, 24-77) months. TKI switch proportions were 32% (570/1766) for first-line, 36% (208/570) for second-line and 34% (71/208) for third-line. Common therapy sequences included imatinib-dasatinib (37%) or nilotinib (35%) in those with 1 switch, imatinib-nilotinib-dasatinib (25%) with 2 switches and imatinib-nilotinib-dasatinib-olverembatinib (18%) with 3 switches. TKI switches were mainly due to resistance (64%, 76%, 88% across lines) and intolerance (19%, 14%, 7%). Multivariable analyses revealed ELTS intermediate/high-risk group (vs. low-risk), male, and lower hemoglobin were significantly associated with a higher probability of TKI switch. Compared to imatinib, initial nilotinib or dasatinib had lower switch rates. Male and ELTS high-risk (vs. low/intermediate) were associated with resistance-related switches, while lower hemoglobin, older age and initial dasatinib or flumatinib (vs. imatinib) were associated with intolerance-related switches to second-line therapy. Second-line imatinib/flumatinib (vs. nilotinib/dasatinib) and no/nonspecific ABL mutation were associated with resistance-related switches to third-line therapy.

CONCLUSION:

These findings emphasized the complexities involved in the management of patients with CP-CML and highlighted the importance of personalized treatment strategies.

01 Feb 2025·CANCER

Patient‐reported outcomes in Chinese patients with chronic myeloid leukemia receiving olverembatinib: Quality of life matters!

Author: Eşkazan, Ahmet Emre

Because patients with chronic myeloid leukemia in chronic phase live longer in the era of tyrosine kinase inhibitors, evaluating health‐related quality of life, especially by patient‐reported outcome measures, plays an important role in the management of their disease. Although more comparative data are still needed, this study demonstrated that olverembatinib therapy improved health‐related quality of life significantly over time in heavily treated patients with chronic myeloid leukemia.

01 Jan 2025·JAMA Oncology

Olverembatinib After Failure of Tyrosine Kinase Inhibitors, Including Ponatinib or Asciminib

Article

Author: Yang, Dajun ; Hunter, Anthony M. ; Koller, Paul B. ; Wang, Cunlin ; Uspenskaya, Olga ; Shuvaev, Vasily ; Fu, Tommy ; Jamy, Omer ; Zherebtsova, Vera ; Wang, Hengbang ; Guo, Huanshan ; Jiang, Lixin ; Cortes, Jorge E. ; Lomaia, Elza ; Kantarjian, Hagop ; Jabbour, Elias ; Zhai, Yifan ; Oehler, Vivian G. ; Baer, Maria R. ; Chen, Zi ; Samarina, Svetlana ; Mukherjee, Sudipto ; Davydkin, Igor ; Turkina, Anna

Importance:

Patients with chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) resistant or intolerant to BCR-ABL1 tyrosine kinase inhibitors (TKIs) have limited treatment options. Olverembatinib, which is approved in China, has only been tested in Chinese patients.

Objective:

To assess the pharmacokinetics, safety, efficacy, and recommended dose of olverembatinib in patients with CML or Philadelphia chromosome–positive ALL resistant or intolerant to at least 2 TKIs.

Design, Setting, and Participants:

This multicenter phase 1b randomized clinical trial was conducted from January 28, 2020, to January 2, 2024, with a median (range) follow-up of 48 (0-166) weeks. Patients with CML or Philadelphia chromosome–positive ALL were enrolled. This bridging study was performed in part to confirm that there are no racial differences in the pharmacokinetic profile of olverembatinib.

Interventions:

Patients were randomly assigned to 30, 40, or 50 mg of olverembatinib orally every other day in 28-day cycles.

Main Outcomes and Measures:

Pharmacokinetic profile of olverembatinib.

Results:

Of 80 included patients, 46 (58%) were male, and the median (range) age was 54.0 (21-80) years. The pharmacokinetic profile of olverembatinib was compatible with alternate-day dosing and similar to that in Chinese patients. Based on investigators’ assessments, 60 patients (75%) experienced at least 1 treatment-related adverse event; 32 (40%) experienced grade 3 or higher treatment-related adverse events; and 12 (15%) experienced treatment-related serious adverse events, none of which were fatal. Frequently reported (10% or more) treatment-emergent adverse events included elevated blood creatine phosphokinase (all grades, 31 [39%]; grade 3 or higher, 10 [13%]) and thrombocytopenia (all grades, 23 [29%]; grade 3 or higher, 14 [18%]). Among evaluable patients with chronic-phase CML, complete cytogenetic response (CCyR) occurred in 31 of 51 patients (61%; 95% CI, 46.1-74.2), and major molecular response (MMR) occurred in 25 of 59 patients (42%; 95% CI, 29.6-55.9). Cytogenetic and molecular responses were similar in patients with or without T315I variants. A total of 15 of 26 patients with prior ponatinib treatment (58%; 95% CI, 36.9-76.6) achieved CCyR, and 11 of 30 (37%; 95% CI, 19.9-56.1) achieved MMR. A total of 4 of 8 patients with asciminib resistance (50%; 95% CI, 15.7-84.3) had CCyR, and 4 of 12 (33%; 95% CI, 9.9-65.1) had MMR. The recommended phase 3 dose of olverembatinib is 30 mg every other day in patients without T315I variants.

Conclusions and Relevance:

In this trial, olverembatinib had a favorable pharmacokinetic profile, was generally well tolerated, and showed strong antileukemic activity in patients with heavily pretreated chronic-phase CML with or without T315I variants, including prior ponatinib and/or asciminib failure. Olverembatinib may provide a viable new treatment option for patients after failure of 2 or more TKIs.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04260022

201

News (Medical) associated with Olverembatinib

13 Mar 2025

·www.fiercebiotech.com

\'I don\'t feel we lost momentum\': Takeda’s oncology execs sharpen focus after restructuring

Takeda\'s oncology leaders are focused on building off their own \"institutional knowledge.\"\n Takeda’s revamped R&D strategy means the drugmaker’s oncology leaders are prioritizing work in tumors across thoracic, gastrointestinal (GI) and hematology, while pushing the Japanese company’s cell therapy work focus to the back burner.“We\'re not doing this in a prescriptive way that would never consider anything outside of that,” Teresa Bitetti, president of Takeda’s global oncology business unit, told Fierce Biotech. “But we are looking at areas that we\'ve defined because of the white space, in terms of the unmet need, because of where the science is moving and where our strength lies.”The oncology approach meshes with the drugmaker’s new overall strategy, P.K. Morrow, M.D., head of Takeda’s oncology therapeutic area unit, told Fierce in a joint interview.In January, Takeda\'s R&D head Andy Plump, M.D., Ph.D., explained that the pharma had narrowed its focus down from 10 or 12 modalities to just four: small molecules, biologics, antibody-drug conjugates (ADCs) and allogeneic cell therapies. Of those core priorities, Takeda’s oncology leaders are taking a deep interest in ADCs, small molecules and complex biologics, Morrow said. So, everything but cell therapy.“It\'s unlikely we\'re going to do any cell therapy deals in the near future,” she said about the fourth modality.“Anytime we\'re dealing with gene therapy or cell therapy, there\'s the potential risk for a durable negative effect,” said Morrow, who joined Takeda last year after serving as Crispr Therapeutics’ chief medical officer. “It doesn\'t happen most of the time, but there\'s always the potential, right?”To protect the patient, cell and gene therapies often require extended follow-up, Morrow explained, noting that the component is an important consideration in drug development. The shift isn’t shocking—Bitetti told Fierce that Takeda wasn’t “actively pursuing” autologous cell therapies at last year’s American Society of Clinical Oncology (ASCO) conference.The sentiment shadows a broader industry trend as cell and gene companies fight to remain relevant. Most recently, Pfizer discontinued hemophilia product Beqvez, emptying its gene therapy portfolio, while bluebird bio sold for just $29 million after having at one time carried a value of $10 billion.Back at Takeda, the team still touts GDX012, also called TAK-012-1501, an allogeneic gamma delta T cell therapy the company gained from buying GammaDelta Therapeutics in 2021. The asset is currently in phase 1/2 testing for adults with acute myeloid leukemia (AML).The team will “continue for now” to pursue early-stage work in cell therapy, Bitetti said.After a wide-ranging $900 million restructure in 2024, Takeda now touts its “most robust late-stage pipeline” in the pharma’s history, consisting of six late-stage programs across 14 studies, Plump told Fierce at the beginning of the year.Developing a more mature pipeline meant that Takeda had to raise its standards, Plump said. Lifting the bar resulted in several programs being left behind, including a midstage CD19 CAR-NK cell therapy in B-cell malignancies. The asset is still being studied in a phase 1 autoimmune disease program.Momentum amid streamlining? “We did do some streamlining, but I sort of feel like we\'ve come out of the back end with a lot of energy [and] focus,” Bitetti said. “I don\'t feel like we\'ve lost momentum with it.”The restructure included implementing a more rigorous approach when considering benefit and safety thresholds that determine what programs should progress, according to Morrow. One of those programs is rusfertide, an injectable hepcidin mimetic designed to treat a rare chronic blood cancer called polycythemia vera (PV). Last year, Takeda paid out $300 million to license the asset from Protagonist Therapeutics.Just this month, the partners reported a phase 3 win, finding that rusfertide reduced blood procedures among patients with PV.Takeda’s plans to file for approval with regulatory authorities are currently “on track,” with a submission expected toward the end of this year, according to Bitetti.If rusfertide passes muster with regulators, the hepcidin mimetic peptide could go on to generate $1 billion to $2 billion in peak sales. The candidate is one of six pipeline drugs that Takeda is hoping will collectively bring in between $10 billion and $20 billion, CEO Christophe Weber said during the company’s J.P. Morgan presentation in January.Takeda isn\'t counting out China When asked about geopolitical changes, such as the BIOSECURE Act and President Donald Trump’s “America First Investment Policy,” Bitetti said Takeda isn’t counting out science from China.“One can\'t afford to ignore the innovation that\'s available today coming out of China,” she said. “It\'s not just me-toos that are coming out of China—there\'s some really interesting science.”Bitetti also cited the country’s rapid pace and ability to get the proof of concept very quickly.While she noted that companies still need to be “judicious” given the changing dynamics, she said one should “proceed at your own risk to ignore what\'s happening in China.”Meanwhile, Morrow pointed to the Japanese drugmaker’s successful partnership with Hong Kong-based Hutchmed, in which Takeda paid $400 million upfront for commercial rights outside of China to a colorectal cancer drug called fruquintinib. The oral vascular endothelial growth factor receptors (VEGFR) 1/2/3 tyrosine kinase inhibitor received FDA approval at the end of 2023 and is now marketed as Fruzaqla. Last summer, Takeda also inked a deal worth up to $1.3 billion biobucks that provides the opportunity to license Ascentage Pharma’s olverembatinib, which is being developed for chronic myeloid leukemia (CML), along with other hematological cancers. The Chinese biotech\'s third-generation BCR-ABL tyrosine kinase inhibitor is currently approved in China for certain patients with CML.As for future deals with biotechs, the leaders are looking for validated modalities in disease areas Takeda believes it can make the greatest impact in.“That\'s what you\'ll see in particular in the deals that we\'ve done in the very recent past,” Morrow said, pointing to a December deal with Keros Therapeutics that included $200 million upfront to secure ex-China rights to a molecule that could compete with Bristol Myers Squibb’s Reblozyl in blood cancer indications.The deal covers Keros’ activin inhibitor elritercept that’s in development to treat anemia tied to blood cancers such as myelodysplastic syndromes and myelofibrosis. Keros sees elritercept as a molecule that can act on all stages of platelet and red blood cell production, leading it to identify opportunities across a broad patient population.Building on strengths Takeda’s pipeline decisions also take the company’s strengths into account, Bitetti said.“We have an enormous strength on the [hematology] side,” she explained. “We have very deep relationships that go back a very long time from the early days of Velcade.”The “institutional knowledge” regarding myeloid cancers and commercializing drugs in the area is something Takeda wants to continue to build on.This is exemplified by Takeda’s purchase of oncology biotech Millennium way back in 2008, according to Morrow.The “Millennium legacy” is vital to the oncology unit because it helped Takeda better understand how to develop therapies that could become backbones to other regimens and helped draw in key talent that has expertise in precision medicine. When asked how diversity, equity and inclusion play a role in the department’s hiring practices, Bitetti said DEI considerations continue to be important.“Our position as a company hasn’t changed on diversity, in terms of doing what we think is right for the business and ensuring that we have the right breadth of perspective, not only in our clinical trials, but also how we manage the business,” Bitetti said.

Phase 3Drug ApprovalCell TherapyAcquisitionPhase 1

24 Jan 2025

·www.pharmaceutical-technology.com

Ascentage Pharma raises $126m in first biotech IPO of 2025

Ascentage sold 7,325,000 American Depositary shares at $17.25 each. Credit: Andrey Zhuravlev via Getty Images. China-based biotech Ascentage Pharma has raised $126m in a US initial public offering (IPO), marking the first biotech IPO of 2025. Free Report What’s missing from your IPO industry assessment? IPO activity all but stopped in 2020, as the investment community grew wary of the effects of COVID-19 on economies. No matter how deserving a business was of flotation, momentum was halted by concerns of when a ‘new normal’ of working patterns and trade would set in. Recently, sentiment has changed. Flotations picked up again during the second half of 2021, and now in 2022 the mood is decidedly optimistic. Business leaders have their eyes on fast rebounding economies, buoyant market indices and the opportunity once again to take their businesses public. As a result, global IPOs are expected to hit back this year. With GlobalData’s new whitepaper, ‘IPOs in Consumer and Retail: 5 must-include elements for your prospectus industry report’, you can explore exactly what is needed in the essential literature. GlobalData’s focus lies in the critical areas to get right: Macroeconomic and demographic environment Consumer context Industry environment Competitive environment Route to market Interested to learn more about what to include in your IPO Industry Assessment report? Download our free whitepaper. Thank you. You will receive an email shortly. Please check your inbox to download the Report. Go deeper with GlobalData Reports LOA and PTSR Model - Bemcentinib in Acute Myelocytic Leukemia (AML,... Reports LOA and PTSR Model - Bemcentinib in Lung Adenocarcinoma Data Insights The gold standard of business intelligence. Find out more Related Company Profiles Nasdaq Inc Bloomberg LP Takeda Pharmaceutical Co Ltd Jefferies Group LLC View all By GlobalData Submit Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this Report, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The company sold 7,325,000 American Depositary shares at $17.25 each. Shares for the company began trading today (24 January) on the Nasdaq under the ticker symbol “AAPG”, and are up by as much as 4% since markets opened, as per Bloomberg . The funds will primarily support the development of Ascentage’s cancer drug pipeline, including its lead candidate olverembatinib for the treatment of chronic myeloid leukaemia (CML). Olverembatinib, a tyrosine kinase inhibitor (TKI), is approved and marketed as Nelic in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) with the T315I mutation, and for those with CP-CML resistant disease or intolerant to first and second generation TKIs. The IPO comes after the company signed a significant licencing agreement with Takeda in 2024. Takeda paid $100m upfront for the option to licence olverembatinib outside China, Hong Kong, Macau, Taiwan, and Russia, and committed to potential milestone payments totalling $1.2bn. The broader IPO market has seen fluctuations in recent years. Following a surge in 2020 and 2021, activity slowed, only to pick up slightly in late 2024. In September 2024, three biotech firms – Bicara Therapeutics, Zenas BioPharma, and MBX Biosciences – raised over $700m collectively in a single day on Nasdaq, reflecting renewed investor interest. Industry sentiment remains optimistic for 2025 , with many expecting IPO activity to increase. A Jefferies survey reported that 64% of respondents anticipate a stronger IPO market this year, with equity raising expected to play a significant role. Ascentage’s listing aligns with this outlook and suggests a favourable environment for biotech funding as the year begins. Ascentage’s olverembatinib is being investigated in the Phase III POLARIS-2 registrational study (NCT06423911) which plans to enrol 285 patients with CML. Beyond olverembatinib, Ascentage has other candidates in its pipeline including lisaftoclax, a treatment for blood cancers. The candidate is in late-stage trials and under regulatory review in China. Free Report What’s missing from your IPO industry assessment? IPO activity all but stopped in 2020, as the investment community grew wary of the effects of COVID-19 on economies. No matter how deserving a business was of flotation, momentum was halted by concerns of when a ‘new normal’ of working patterns and trade would set in. Recently, sentiment has changed. Flotations picked up again during the second half of 2021, and now in 2022 the mood is decidedly optimistic. Business leaders have their eyes on fast rebounding economies, buoyant market indices and the opportunity once again to take their businesses public. As a result, global IPOs are expected to hit back this year. With GlobalData’s new whitepaper, ‘IPOs in Consumer and Retail: 5 must-include elements for your prospectus industry report’, you can explore exactly what is needed in the essential literature. GlobalData’s focus lies in the critical areas to get right: Macroeconomic and demographic environment Consumer context Industry environment Competitive environment Route to market Interested to learn more about what to include in your IPO Industry Assessment report? Download our free whitepaper. Thank you. You will receive an email shortly. Please check your inbox to download the Report. By GlobalData Submit Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this Report, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Phase 3IPODrug Approval

24 Jan 2025

·medcitynews.com

Ascentage Has First U.S. Biotech IPO of 2025, Raising $126M to Bring Its Cancer Meds to the World - MedCity News

Ascentage Pharma, a China-based drug developer with global ambitions, now has $126.4 million from a U.S. IPO that will mainly support late-stage clinical development of two medicines that could offer advantages over some currently available cancer therapies. Ascentage has traded on The Stock Exchange of Hong Kong since 2019. In preliminary financial terms set earlier this week for its U.S. stock market debut, the company planned to offer more than 7.3 million American depositary shares (ADS) priced at $20.34 each. Late Thursday, Ascentage, which is based in Suzhou, China, and maintains U.S. operations in Rockville, Maryland, priced its offering at $17.25 per ADS. Those shares will trade on the Nasdaq under the stock symbol “AAPG.” The only commercialized Ascentage product is olverembatinib, a drug approved in China as a treatment for certain patients with chronic myeloid leukemia (CML). This drug is a small molecule inhibitor of tyrosine kinases, enzymes that drive cancer growth. Tyrosine kinase inhibitors (TKIs) are already available, such as the Novartis drugs Scemblix and Gleevec. But CML can become resistant to these therapies, Ascentage said in its IPO filing. Furthermore, first- and second-generation TKIs have not been able to address CML with T315I mutations, which are associated with rapid disease progression and limited patient survival. Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient Ascentage describes olverembatinib as a next-generation drug for CML that is driven by T315I mutations and is also resistant to first- and second-generation TKIs. The company points to real-world data in China showing benefit in patients whose cancers developed resistance to the Novartis drugs. “In a five-year follow-up of CML [in the chronic phase] patients treated with olverembatinib, 73% had remained on the treatment, response rates continued to increase and the prevalence of treatment-related adverse events, or TRAEs, continued to decrease over such period,” Ascentage said in the IPO filing. “Therefore, we believe that olverembatinib, with its real-world patient data in China, where it is approved, has the potential to be a global therapy for CML.” An ongoing Phase 3 clinical program for olverembatinib is enrolling patients in the U.S., Canada, Australia, and China. One of these pivotal studies is testing the drug as a monotherapy for CML. The design of this study is intended to support an FDA new drug application, which Ascentage plans to file in 2026. Additional Phase 3 tests are evaluating olverembatinib in newly diagnosed Philadelphia chromosome-positive acute lymphocytic leukemia and gastrointestinal stromal tumor. Olverembatinib may achieve Ascentage’s global ambitions in the hands of a big pharmaceutical company. Last June, Ascentage granted Takeda Pharmaceuticals International an exclusive option to license olverembatinib for development and commercialization outside of greater China and Russia. Takeda paid $100 million for that option; the option exercise fee and milestone payments could bring Ascentage up to $1.2 billion more, according to the IPO filing. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical The next drug in Ascentage’s pipeline is lisaftoclax, a small molecule inhibitor of Bcl-2. Overexpression of this protein can contribute to tumor growth and drug resistance. Ascentage is developing lisaftoclax for various types of blood cancers. A new drug application for the molecule is under regulatory review in China for the treatment of advanced cases of chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). If approved, Ascentage plans to launch the lisaftoclax in China in 2025 and then pursue regulatory approvals in multiple countries, according to the filing. Its main competition would be Venclexta, a Bcl-2 inhibitor marketed by partners AbbVie and Genentech. However. Venclexta is not currently approved in China for CLL or SLL. The Ascentage pipeline includes additional small molecules in earlier stages of development, mainly for cancers. Ascentage co-founder Edward Ming Guo is the company’s largest shareholder with a 17.5% post-IPO stake, according to the prospectus. Takeda owns 7.1% of the company. In the nine months ended Sept. 30, 2024, Ascentage reported 876.8 million Chinese yuan (about $124.9 million) in revenue, most of which came from the Takeda option deal. At the end of the third quarter of 2024, Ascentage reported its cash position was $210.8 million. With the IPO proceeds, Ascentage plans to spend $30 million to $40 million for clinical development of olverembatinib in the U.S. and other countries, and to expand the drug’s label to earlier lines of CML treatment among other indications, according to the prospectus. Another $50 million to $60 million is budgeted for the regulatory approval and potential commercial launch in China of lisaftoclax as a treatment for relapsed or refractory CLL. The company also plans to run clinical trials that could support approvals of this drug in the U.S. and other countries. Between $10 million and $20 is set aside to fund R&D of other drug candidates.

Drug ApprovalPhase 3IPOLicense out/inAcquisition

100 Deals associated with Olverembatinib

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16185

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Aggressive-Phase Chronic Myelocytic Leukemia	China	Guangzhou Shunjian Biomedical Technology Co., Ltd.	24 Nov 2021
Chronic phase chronic myeloid leukemia	China	Guangzhou Shunjian Biomedical Technology Co., Ltd.	24 Nov 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
SDH-deficient Gastrointestinal Stromal Tumors	Phase 3	China	Ascentage Pharma Group, Inc.	11 Nov 2024
SDH-deficient Gastrointestinal Stromal Tumors	Phase 3	China	Guangzhou Shunjian Biomedical Technology Co., Ltd.	11 Nov 2024
Philadelphia positive acute lymphocytic leukaemia	Phase 3	China	Ascentage Pharma Group, Inc.	31 Aug 2023
Philadelphia positive acute lymphocytic leukaemia	Phase 3	China	Guangzhou Shunjian Biomedical Technology Co., Ltd.	31 Aug 2023
Philadelphia positive acute lymphocytic leukaemia	Phase 3	Australia	Ascentage Pharma Group, Inc.	31 Aug 2023
Philadelphia chromosome-positive acute lymphoblastic leukemia in relapse	Phase 2	China	Ascentage Pharma Group International Co., Ltd.	12 Jul 2022
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 2	China	Ascentage Pharma Group, Inc.	08 Apr 2019
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 2	China	Guangzhou Shunjian Biomedical Technology Co., Ltd.	08 Apr 2019
Philadelphia Chromosome Positive Acute Myeloid Leukemia	Phase 1	United States	Ascentage Pharma Group, Inc.	06 Aug 2024
Acute Lymphoblastic Leukemia	Phase 1	Canada	Ascentage Pharma Group International Co., Ltd.	22 Jul 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04260022 (Pubmed \| JAMA Oncol)	Phase 1	T315I variants	80	Olverembatinib 30 mg	kpgzmzziot(osljuitbdz) = all grades, 31 [39%]; grade 3 or higher, 10 [13%] gqaoyippob (khvebdfzss ) View more	Positive	01 Jan 2025
NEWS Manual	Not Applicable	Chronic phase chronic myeloid leukemia Second line	43	Orebatinib 40mg QOD	qlzcayhldb(sgtppjenas) = kpuiqmhpkn zwivczumoa (kwvfzmcxaf ) View more	Positive	09 Dec 2024
NCT04260022 (ASH2024) Manual	Phase 1	Chronic phase chronic myeloid leukemia	66	Total	lsywxedcxf(ocnbkuuvce) = efjgucilwu mmnqqiemob (cqzrxtixwz ) View more	Positive	08 Dec 2024
NCT04260022 (ASH2024) Manual	Phase 1	Chronic phase chronic myeloid leukemia	66	Olverembatinib (T315I mutation)	lsywxedcxf(ocnbkuuvce) = erwgnewazu mmnqqiemob (cqzrxtixwz ) View more	Positive	08 Dec 2024
ASH2024 Manual	Not Applicable	Philadelphia positive acute lymphocytic leukaemia First line	26	Olverembatinib + Vindesine + Prednisone	opttsiisxj(ojihlppcab) = No patients had adverse reactions leading to dose reduction or discontinuation, and no treatment-related non-hematological adverse reactions were observed. wgccpmhrjg (stwguinqof )	Positive	07 Dec 2024
NCT05521204 (ASH2024) Manual	Phase 2	Myeloproliferative Disorders \| acute leukemia FGFR1 Rearrangement	10	Olverembatinib	mjxbsycrpy(hmoutfmfin) = jvqafwvrbk zbcetwdwwh (ebtvxxwxjs ) View more	Positive	07 Dec 2024
NCT04260022 (Literature) Manual	Phase 1	Philadelphia positive acute lymphocytic leukaemia \| Philadelphia chromosome positive chronic myelogenous leukemia	80	Olverembatinib	dbikkvaplg(wwqavpjcrp) = baxfssgsbf bsrnhbspru (aqnxdiutvl, 29.6 - 55.9) View more	Positive	21 Nov 2024
NCT04260022 (Literature) Manual	Phase 1		80	Olverembatinib (prior ponatinib treatment)	dbikkvaplg(wwqavpjcrp) = peswwmsysh bsrnhbspru (aqnxdiutvl, 19.9 - 56.1) View more	Positive	21 Nov 2024
NCT03594422 (HQP1351-SJ0003, ESMO2024) Manual	Phase 1	SDH-deficient Gastrointestinal Stromal Tumors SDHD Deficient Expression	26	Olverembatinib 20 mg	oymcfgbtxb(olwijsepvk) = cascupnmdd vulmndfmio (lcgsnejrsf, 12.9 - 38.6)	Positive	13 Sep 2024
SOHO2024	Not Applicable	Philadelphia chromosome positive chronic myelogenous leukemia	-	Olverembatinib 30 mg QOD	tgtqfmhftu(itjiahrqjl) = 38.8% experienced elevated blood creatine phosphokinase ltyebfugmg (faglhbsbcu ) View more	-	04 Sep 2024
SOHO2024	Not Applicable		-	Ponatinib		-	04 Sep 2024
PRNewswire Manual	Not Applicable	Chronic Myelogenous Leukemia	159	olverembatinib	uyoasqgstg(dvwksippuo) = the top 3 severe symptom burdens at baseline were financial difficulties, fatigue, and insomnia. Eight scale items including global health, physical functioning, emotional functioning, fatigue, pain, dyspnea, diarrhea and financial difficulties improved significantly during olverembatinib therapy. No scale deteriorated significantly. In multivariate analysis, age < 40 years was associated with better improvement of social functioning (p = 0.021); CP (vs. AP), better improvement of dyspnea (p = 0.028) and diarrhea (p = 0.042); achieving MMR, better improvement of global health (p = 0.005), nausea and vomiting (p = 0.009), and diarrhea (p = 0.001). wyyncegexy (hnrjktriyw ) View more	Positive	18 Jun 2024
NCT03594422 (SJ-0003, ASCO2024) Manual	Phase 1	Paraganglioma \| SDH-deficient Gastrointestinal Stromal Tumors Loss of SDH Expression	32	Olverembatinib 30 mg	pyfqoopgvv(peoctxjlvj) = cowkriqkfy ojcckibnif (kxoprjegjo ) View more	Positive	24 May 2024
NCT03594422 (SJ-0003, ASCO2024) Manual	Phase 1		32	Olverembatinib 40 mg	pyfqoopgvv(peoctxjlvj) = dhwdeiwxwf ojcckibnif (kxoprjegjo ) View more	Positive	24 May 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis