CELTIC-1 (Clinical Evaluation of T-cell NHL With Cerdulatinib): A Phase 2b, Open Label, Multidose, Multinational Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)

This is an open-label, multinational study of cerdulatinib in patients with relapsed/refractory PTCL dosed with cerdulatinb, designed to (1) Evaluate tumor response, (2) Assess the safety and tolerability of cerdulatinib, (3) Evaluate duration of response (DUR), progression free survival (PFS) and overall survival(OS), (4) Determine the PK properties of cerdulatinib, (5) Evaluate the efficacy endpoints based on Lugano criteria per IRC and (6)To assess the relationship between target expression (e.g., spleen tyrosine kinase [SYK], Janus kinase [JAK]) and relevant anomalies (e.g., SYK-ITK translocation, mutations in the JAK/STAT pathway) with clinical response.

Start Date15 Nov 2019

Sponsor / Collaborator

Portola Pharmaceuticals LLC

NCT03728166

/ RecruitingNot ApplicableIIT

Randomized Controlled Trial of Computerized Decision Support for Prevention of Venous Thromboembolism in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)

Hospitalized medical patients have an increased risk of venous thromboembolism (VTE) across the continuum of care, including after hospital discharge. In the APEX Trial of hospitalized patients with acute medical illness, extended-duration post-discharge thromboprophylaxis with oral betrixaban reduced the frequency of asymptomatic proximal deep venous thrombosis (DVT), symptomatic proximal or distal DVT, symptomatic nonfatal pulmonary embolism (PE), or VTE-related death compared with short-duration enoxaparin. Obstacles to integration of these data in the hospitalized Medical Service patient population, including failure to identify at-risk patients, educational gaps in strategies for VTE prevention after discharge, and medication nonadherence, can be overcome with alert-based computerized decision support. This study is a single-center, 400-patient, randomized controlled trial of an EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase prescription of extended-duration post-discharge thromboprophylaxis and decrease symptomatic VTE in high-risk patients hospitalized with medical illness.
Specific Aim #1: To determine the impact of electronic alert-based CDS (EPIC Best Practice Advisory [BPA]) on prescription of extended-duration post-discharge thromboprophylaxis in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge.
Specific Aim #2: To estimate the impact of electronic alert-based CDS (EPIC BPA) on the frequency of symptomatic VTE in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge.

Start Date01 Feb 2019

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

[+1]

NCT03346083

/ TerminatedPhase 1

A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Betrixaban in Pediatric Patients

This trial was a Phase 1, open-label, multicenter study of the pharmacokinetics (PK), pharmacodynamics (PD), and safety of a single dose of betrixaban in pediatric participants at risk of venous thromboembolism (VTE).

Start Date13 Jul 2018

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Portola Pharmaceuticals LLC

0 Patents (Medical) associated with Portola Pharmaceuticals LLC

Literatures (Medical) associated with Portola Pharmaceuticals LLC

01 Apr 2022·Journal of the American College of Emergency Physicians open

Thirty‐day mortality with andexanet alfa compared with prothrombin complex concentrate therapy for life‐threatening direct oral anticoagulant‐related bleeding

Article

Author: Connolly, Stuart J ; MacCallum, Peter ; Curnutte, John ; Yue, Patrick ; Cohen, Alexander T ; Lewis, Megan ; Alikhan, Raza ; Connor, Augusta ; Tan, Joachim ; Green, Laura

Abstract:

Objective:

Compare 30‐day mortality among patients receiving the specific reversal agent andexanet alfa versus replacement prothrombin complex concentrate (PCC) in the management of direct‐acting oral anticoagulant (DOAC)–related bleeds.

Methods:

Two patient‐level datasets were used: ANNEXA‐4, a prospective, single‐arm trial of patients taking apixaban or rivaroxaban who received andexanet alfa and ORANGE, a prospective, observational study of anticoagulated patients in UK hospitals, some of whom received PCC. Patients were propensity score matched based on demographic and clinical characteristics. Subgroup analyses were performed by bleed type (intracranial hemorrhage [ICH], gastrointestinal [GI], other). Relative risk (RR) of all‐cause 30‐day mortality was calculated.

Results:

322 ANNEXA‐4 patients treated with andexanet alfa (mean age = 77.7 years; 64.9% ICH) were matched with 88 ORANGE patients treated with PCC (mean age = 74.9 years, 67.1% ICH). Adjusted 30‐day mortality for patients treated with andexanet alfa (14.6%) was lower than patients treated with PCC (34.1%; RR, 0.43; 95% CI, 0.29–0.63). In the ICH subgroup, patients treated with andexanet alfa had lower mortality (15.3%) than patients treated with PCC (48.9%; RR, 0.31; 95% CI, 0.20–0.48). Mortality risk was lowest for patients in the GI subgroup but did not differ significantly by treatment (12.2% for andexanet alfa vs 25.0% for PCC; RR, 0.49; 95% CI, 0.21–1.16).

Conclusions:

In this propensity score–matched comparison across 2 independent datasets, adjusted 30‐day mortality rates were lower for patients treated with andexanet alfa than in matched patients receiving PCC. This indirect comparison was limited in that it could not account for several highly predictive variables including GCS score, hematoma volume, and expected survival. Further research is warranted to confirm the mortality differences between reversal/replacement agents for DOAC‐related bleeding.

01 Feb 2021·International journal of stroke : official journal of the International Stroke SocietyQ2 · MEDICINE

Semi-automatic measurement of intracranial hemorrhage growth on non-contrast CT

Q2 · MEDICINE

Article

Author: Al Sultan, Abdulaziz Sulaiman ; Curnutte, John T ; Menon, Bijoy K ; Choi, Hyun Seok ; Qiu, Wu ; Chung, Kevin J ; Yue, Patrick ; Connolly, Stuart J ; Kasickova, Linda ; Federico, Alyssa ; Crowther, Mark ; Demchuk, Andrew M ; Horn, MacKenzie ; Kuang, Hulin

Background:

Manual segmentations of intracranial hemorrhage on non-contrast CT images are the gold-standard in measuring hematoma growth but are prone to rater variability.

Aims:

We demonstrate that a convex optimization-based interactive segmentation approach can accurately and reliably measure intracranial hemorrhage growth.

Methods:

Baseline and 16-h follow-up head non-contrast CT images of 46 subjects presenting with intracranial hemorrhage were selected randomly from the ANNEXA-4 trial imaging database. Three users semi-automatically segmented intracranial hemorrhage to measure hematoma volume for each timepoint using our proposed method. Segmentation accuracy was quantitatively evaluated compared to manual segmentations by using Dice similarity coefficient, Pearson correlation, and Bland–Altman analysis. Intra- and inter-rater reliability of the Dice similarity coefficient and intracranial hemorrhage volumes and volume change were assessed by the intraclass correlation coefficient and minimum detectable change.

Results:

Among the three users, the mean Dice similarity coefficient, Pearson correlation, and mean difference ranged from 76.79% to 79.76%, 0.970 to 0.980 ( p < 0.001), and −1.5 to −0.4 ml, respectively, for all intracranial hemorrhage segmentations. Inter-rater intraclass correlation coefficients between the three users for Dice similarity coefficient and intracranial hemorrhage volume were 0.846 and 0.962, respectively, and the corresponding minimum detectable change was 2.51 ml. Inter-rater intraclass correlation coefficient for intracranial hemorrhage volume change ranged from 0.915 to 0.958 for each user compared to manual measurements, resulting in an minimum detectable change range of 2.14 to 4.26 ml.

Conclusions:

We spatially and volumetrically validate a novel interactive segmentation method for delineating intracranial hemorrhage on head non-contrast CT images. Good spatial overlap, excellent volume correlation, and good repeatability suggest its usefulness for measuring intracranial hemorrhage volume and volume change on non-contrast CT images.

01 Dec 2020·Journal of medical economicsQ4 · MEDICINE

Major bleed costs of atrial fibrillation patients treated with factor Xa inhibitor anticoagulants

Q4 · MEDICINE

Article

Author: Lingohr-Smith, Melissa ; Christoph, Mary J. ; Deitelzweig, Steven B. ; Lovelace, Belinda ; Lin, Jay ; Fermann, Gregory J.

OBJECTIVE:

To examine the healthcare economic burden of atrial fibrillation (AF) patients treated with factor Xa inhibitor (FXaI) anticoagulants who were hospitalized in the US with a major bleed (MB).

METHODS:

Adult AF patients treated with FXaIs and hospitalized with an MB were selected from MarketScan databases (1 January 2015-30 April 2018). Patients were grouped into cohorts based on type of MB: intracranial hemorrhage (ICH), gastrointestinal (GI), other types of MB. Healthcare costs in 2019 USD were evaluated for index hospitalizations and during a variable follow-up period in unadjusted and adjusted analyses.

RESULTS:

Of the overall AF patient population treated with FXaIs and hospitalized with an MB (n = 7,577), 9.9% had ICH (mean age: 77.9 years; 58% male), 55.9% had GI (mean age: 76.8 years; 52% male), and 34.2% had other types of MB (mean age: 74.4 years; 61% male). Mean index hospitalization costs for ICH, GI, and other type of MB were $54,163, $26,901, and $36,645, respectively; from adjusted analyses, patients with ICH vs. GI spent 1.6 more days in the hospital; mean cost was $15,630 higher. Patients with other types of MB vs. GI spent 0.6 more days in the hospital; mean cost was $5,859 higher. Index hospitalization cost in addition to total all-cause healthcare costs incurred in the follow-up period were $34,522 higher per ICH patient and $11,584 higher per other type of MB patient vs. a GI MB patient.

LIMITATIONS:

Since this study was a retrospective observational study using a claims database analysis, a causal relationship between treatment with FXaIs and MB events cannot be established.

CONCLUSIONS:

Although all of the evaluated MB types were associated with high hospitalization costs, ICH was associated with the most substantial short- and long-term healthcare economic burden.

News (Medical) associated with Portola Pharmaceuticals LLC

11 Feb 2025

·www.globenewswire.com

BioXcel Therapeutics Provides Clinical and Business Update

Patient enrollment advancing in SERENITY At-Home Phase 3 trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia Developed plans for TRANQUILITY In-Care Phase 3 trial of BXCL501 for agitation associated with Alzheimer’s dementia Enhanced operational and financial flexibility through existing credit amendment Strengthened strategic leadership with recent Board appointments Feb. 05, 2025 -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today provided an update on the progress of its late-stage clinical programs for lead neuroscience asset BXCL501, as well as its recent steps to enhance operational and financial flexibility and strengthen its Board leadership. “We continue to focus on advancing our SERENITY and TRANQUILITY programs to bring a much-needed new treatment option to address the estimated 140 million annual acute agitation episodes associated with bipolar disorders, schizophrenia, and Alzheimer’s dementia1-3,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “In addition, we have strengthened the business by amending our existing credit agreement, raising capital, and appointing additional leaders with considerable operational and clinical expertise to our Board of Directors. In parallel, we are continuing to manage costs and more closely align management and shareholder interests. Collectively, we believe these actions will help create value for all stakeholders.” The majority of trial sites have been opened and patient enrollment is progressing with the SERENITY At-Home trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia. Developed plans for the TRANQUILITY In-Care trial of BXCL501 for agitation associated with Alzheimer’s dementia (AAD). The Company plans to continue to supply IGALMI® to current and future customers through existing distribution channels, without commercial support. Continue to generate deeper mechanistic insights for BXCL502 in support of its potential to be developed for the treatment of chronic AAD. A poster was presented at the annual meeting of the American College of Neuropsychopharmacology in Phoenix in December 2024. Enhanced operational and financial flexibility through existing credit agreement amendment announced on Nov. 25, 2024. Successfully raised $7 million gross proceeds in equity funding, which closed on Nov. 25, 2024. The company has strengthened its Board of Directors with clinical, financial, and legal expertise. Dr. Rajiv Patni has broad global product-development expertise in diverse therapeutic areas. He is currently CEO of Judo Bio, having previously served as Chief R&D Officer at Reata Pharmaceuticals, a commercial-stage company acquired by Biogen. Earlier, Dr. Patni was Chief Medical Officer at Global Blood Therapeutics, Portola Pharmaceuticals, and Adamas Pharmaceuticals, until their acquisitions by larger companies. He also held roles of increasing responsibility at Pfizer, Roche, and Actelion. David Mack has a distinguished record of providing financial and legal leadership to a diverse range of domestic and international companies that has enabled them to effectively navigate through periods of transition. He has more than 25 years of experience as an attorney, director, and investor. He has extensive experience in leading transactions as well as deep knowledge of complex business matters. Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. References 1. Data on file relating to agitation episodes associated with schizophrenia or bipolar I or II disorder. BioXcel Therapeutics, Inc. New Haven, CT December 2020. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller. 2. Data from Wu EQ, Shi L, Birnbaum H, et al. Annual prevalence of diagnosed schizophrenia in the USA: a claims data analysis approach. Psychol Med. 2006;36(11):1535-1540. Estimates based on whether indications are approved for at-home use for the intended patient population and such patients are treatable. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller. 3. National Institute of Mental Health. Prevalence of bipolar disorder in adults. November 2017. Accessed December 16, 2022. https://www-nimh-nih-gov.libproxy1.nus.edu.sg/health/statistics/bipolar-disorder. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller. The content above comes from the network. if any infringement, please contact us to modify.

Executive ChangeFast TrackBreakthrough Therapy

06 Jan 2025

·www.biopharmadive.com

An evolution in leadership and vision for this pharma company

About four years ago, Sheldon Koenig was thinking about retiring. After spending decades in leadership roles at different pharmaceutical companies, hed led a successful career focused largely on cardiovascular therapeutics. Along the way, hed endured his own personal challenges with healthincluding a battle with cancer, which led him to discover he also had high cholesterol.But before he made the decision to leave the workforce, he was offered a job with Esperion Therapeutics and saw the potential to make an even greater impact on heart health. The opportunity to lead a company with both the challenges and the potential to provide a much-needed alternative to current treatments in cardiology was too great to turn down, says Koenig. He joined the company as chief operating officer in 2020 and in 2021 was promoted to president and chief executive officer.The years that hes been at the helm of Esperion have been a period of transformation for the company, which recently received FDA approval for broad new label expansions for its products. Koenig sat down with BioPharma Dive to talk about whats changedand whats nextwith the ever-evolving Esperion.What drew you to working at Esperion in 2020?I have been fortunate to spend most of my professional career working in cardiovascular health and it is a personal passion of mine to bring life-saving medicines to patients in need. People forget that cardiovascular disease remains the No. 1 cause of death for both men and women in the U.S. and worldwide. At Sanofi S.A., I served as senior vice president and head of the cardiovascular franchise. Prior to that, I was vice president and global brand leader for the cardiovascular division of Merck & Co. taking on roles of increasing responsibility within the companys cardiovascular and thrombosis franchises.Esperion CEO, Sheldon KoenigHowever, it is my own battle with cancer, where I have truly witnessed the transformative power of medical breakthroughs and the invaluable role they play in prolonging and improving the lives of countless individuals. This personal connection has only strengthened my resolve to contribute to the advancement of medical knowledge and the development of progressive treatments.When I was approached by Esperion, I was serving as executive vice president and chief commercial officer at Portola Pharmaceuticals until it was acquired by Alexion in August 2020. At that time, I was toying with the idea of retirement, but when I was presented with the Esperion opportunity it made me realize I still had more to accomplish.How has your experience with cancer, and your overall health journey, shaped you as a business leader?Ironically, it was while I was under treatment for cancer that my oncologist recommended I see a cardiologist about my high LDL cholesterol. From my professional experience I was well aware of the risks of elevated LDL. Today, I can speak with customers, investors and colleagues not only about the strong science behind our brands but also from my personal experience and success taking an Esperion product, myself.Since becoming president and CEO in 2021, what are some of your proudest accomplishments?While there have been many accomplishments leading up to 2024, this has been a truly transformational year for the company. First, we received FDA approval for an expanded label for our products that significantly increased the potential patient population of the previous highly restrictive indication. Simultaneous with pursuing the expanded label approval, we doubled Esperions existing sales force to prepare for the launch of the expanded indications. We also developed and launched an innovative and primarily digital marketing campaign to target and reach the widest possible audience of healthcare providers and patients utilizing impactful characters known as the Lipid Lurkers.Outside the U.S., we also solidified our relationship with our European partner, Daiichi Sankyo Europe (DSE), which led to DSE obtaining a label expansion for both brands in Europe. In Japan, our partner, Otsuka Pharmaceuticals, met the primary endpoint in Phase 3 clinical trials, moving the approval forward for that country. These are all exciting developments that illustrate how Esperion is poised for growth.What are your goals for 2025?I have three goals for 2025 that will lead us into an even brighter future. First, to continue to inform healthcare providers about our currently marketed products as well as expanding patient access and education for patients on their treatment options for uncontrolled LDL cholesterol. Second, continue to solidify our presence outside the U.S. by working with current partners and launching into other desirable world markets. Third, expanding our portfolio both through new partnerships and our Next Gen Program, which is exploring new therapeutic opportunities in ATP-citrate lyase (ACLY) biology, with the goal to develop next-generation inhibitors optimized to address multiple life-threatening diseases.Looking further ahead, whats your vision for Esperion?Esperion is priming to become more than a cardiovascular company by exploring broad spectrum opportunities in categories with no current standard of care. While I cant say too much on that topic yet, I can say that what lies ahead is incredibly exciting.In the more immediate future, we are thrilled to be presenting at the 2025 JPM Healthcare Conference. Esperion will have some news to share, including details on our upcoming R&D Day in the spring and developments in our pipeline. We look forward to meeting other innovators in the industry at the conference. For those who are unable to attend, our presentation will be available to anyone through a link on esperion.com.Esperion discovers, develops and commercializes innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. To learn more visit esperion.comand esperionscience.com. '

Phase 3Executive ChangeDrug ApprovalAcquisitionClinical Result

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

100 Deals associated with Portola Pharmaceuticals LLC

100 Translational Medicine associated with Portola Pharmaceuticals LLC

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Pipeline Snapshot as of 28 Mar 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 2

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Andexanet alfa ( factor Xa )	Hemorrhage More	Approved
PRT-2761 ( Syk )	Conjunctivitis, Allergic More	Phase 2
PRT318 ( Syk )	Heparin-induced thrombocytopenia More	Preclinical
Betrixaban ( factor Xa )	Venous Thromboembolism More	Withdrawn
Cerdulatinib ( JAK1 x JAK3 x Syk )	Anaplastic Large-Cell Lymphoma More	Discontinued

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