Olverembatinib

Poster presentations from ongoing clinical trials of two core assets, olverembatinib and lisaftoclax, highlight global innovation capabilities in hematologic malignancies ROCKVILLE, Md. and SUZHOU, China, June 14, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to address unmet medical needs in cancer, announced today that seventeen clinical updates from its core assets were presented at the 31 st Congress of the European Hematology Association (EHA2026), including eight poster presentations. The presentations featured data from ongoing clinical studies of olverembatinib (HQP1351), the first third-generation BCR-ABL1 inhibitor approved in China, and lisaftoclax (APG-2575), the first approved China-developed Bcl-2 selective inhibitor. The EHA2026 Congress convened in Stockholm, Sweden, from June 11 to 14, 2026. At the EHA2026 Congress, presentations on olverembatinib comprised key concurrent updates across two therapeutic areas: chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). In CML, olverembatinib demonstrated deep and durable responses in patients with chronic-phase CML (CML-CP) without the T315I mutation, in whom the disease was resistant and/or intolerant to first-line TKI therapy, supporting its potential as a second-line treatment option. For CML-CP patients who have failed treatment with at least two prior TKIs, olverembatinib can be used as a standard treatment option. In addition, olverembatinib showed positive clinical data in CML patients with multiline TKI resistance and co-occurring high-risk genetic mutations. In Ph+ ALL, olverembatinib continued to demonstrate robust clinical response, with updated data from the first-line global registrational Phase III study (POLARIS-1) further validating its deep response rate and manageable safety profile. The chemotherapy-free combination regimen with lisaftoclax yielded encouraging clinical data in subpopulations such as pediatric patients with relapsed/refractory Ph+ ALL. Updated data from the registrational Phase II study of lisaftoclax in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) were also presented. Stratified analyses correlating baseline characteristics with prognosis provided important insights that will inform refinement of treatment strategies and optimization of individualized dosing regimens across different patient populations. The real-world data on lisaftoclax in myeloid neoplasms also provides robust evidence for its clinical utility. Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, said: “The clinical updates on olverembatinib and lisaftoclax presented at EHA2026 further validate the therapeutic value of these two key assets in the global hematologic malignancy field. Olverembatinib has the potential to become an important treatment option for CML, while offering new treatment possibilities for Ph+ ALL patients. The updated data from the registrational Phase II study of lisaftoclax in CLL/SLL will help guide individualized dosing strategies across different patient populations. Its real-world data in myeloid malignancies further strengthens our confidence in its clinical application among such patients. We are particularly encouraged by the promising combination data. Looking ahead, we will continue to accelerate the global clinical development of our key assets, while actively exploring more innovative combination treatment strategies to provide meaningful treatment options for patients around the world.” Key highlights of the selected poster presentations at EHA2026 are as follows (for more information of the Company’s candidates, please visit the official EHA website): EFFICACY OF OLVEREMBATINIB IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) WITH PRIOR RESISTANCE TO PONATINIB OR ASCIMINIB AND ASXL1 MUTATIONS Abstract Number: EHA-3991 (PS1727) First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center Key Highlights: This Phase Ib study performed mutational analyses on 22 patients with ponatinib- and/or asciminib-resistant CP-CML and evaluated the antileukemic activity of olverembatinib across different mutational backgrounds. ASXL1 mutations were present in 40.9% (9/22) of patients. After olverembatinib treatment, 44.4% (4/9) of patients with ASXL1 mutations achieved clinical responses, including 22.2% (2/9) who achieved MMR, one of whom achieved MR4.5. This study provided the first evidence that olverembatinib is active in patients with ponatinib- and/or asciminib-resistant CP-CML, including those harboring challenging genotypes such as ASXL1 mutations, highlighting its potential as a treatment option for patients with multi-line TKI-resistant disease. UPDATED EFFICACY AND SAFETY OF OLVEREMBATINIB (HQP1351) AS SECOND-LINE THERAPY IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) Abstract Number: EHA-3388 (PS1733) First Author: Weiming Li, MD, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Key Highlights: This single-arm, multicenter, open-label Phase II study evaluated olverembatinib as a second-line treatment in patients with CP-CML without the T315I mutation. Among 42 evaluable patients, the complete cytogenetic response (CCyR) rate was 76.2% and the major molecular response (MMR) rate was 47.6%. Responses deepened over time with longer treatment duration, and olverembatinib exhibited manageable tolerability with no treatment-related deaths. These findings support the potential of olverembatinib to induce durable and deep responses in patients with CP-CML without the T315I mutation whose disease was resistant and/or intolerant to first-line TKI therapy, further supporting its role as a second-line treatment option. THE EFFICACY AND SAFETY OF SWITCHING TO OLVEREMBATINIB OR CONTINUING ORIGINAL TKI THERAPY IN CML-CP PATIENTS TREATED WITH AT LEAST TWO PRIOR TKIS: A PROSPECTIVE, MULTICENTER, CONTROLLED TRIAL Abstract Number: EHA-4595 (PS1728) First Author: Bingbing Wen, the Second People’s Hospital of Shenzhen Key Highlights: This prospective, multicenter, controlled trial enrolled 105 patients with CML-CP who had received at least two prior TKIs for ≥18 months and failed to achieve MMR. Patients were assigned in a 1:2 ratio to either switch to olverembatinib (40 mg orally every other day) or continue their most recent TKI therapy. Results showed that the 6-month MMR rate was significantly higher in the olverembatinib group than in the control group (54.3% vs 10.0%; P<0.001). At 12 months, the cumulative incidence of MMR was 57.14% in the olverembatinib group compared with 21.43% in the control group (P<0.0001). Common grade 3/4 hematologic treatment-emergent adverse events (TEAEs) included thrombocytopenia (42.86%) and anemia (17.14%). Grade 3/4 non-hematologic adverse events were rare. Notably, 78.57% of adverse events related to prior TKI therapy improved after patients switched to olverembatinib. These findings support olverembatinib as a potential standard of care for patients with CML-CP previously treated with at least two TKIs. UPDATED RESULTS OF POLARIS-1 (PART 1), A GLOBAL REGISTRATIONAL PHASE 3 STUDY: OLVEREMBATINIB COMBINED WITH LOW-INTENSITY CHEMOTHERAPY IN NEWLY DIAGNOSED PH+ ALL Abstract Number: EHA-3437 (PS1479) First Author: Suning Chen, The First Affiliated Hospital of Soochow University Key Highlights: This global, multicenter, registrational Phase III study (POLARIS-1 Part 1) is evaluating the efficacy and safety of olverembatinib in combination with reduced-intensity chemotherapy in patients with newly diagnosed Ph+ ALL. A total of 55 patients were enrolled. By the end of induction, the CR/CRi rate reached 94.4% and the MRD-negative CR rate reached 63.0%. MRD-negativity rates increased over time, reaching 93.1% by the end of cycle 9. The regimen demonstrated a manageable safety profile, with no meaningful differences in efficacy or safety observed between the 30 and 40mg dose groups. Encouraging activity was also observed in patients with adverse prognostic genotypes, including IKZF1 plus . These findings suggest that olverembatinib combined with low-intensity chemotherapy may induce rapid, deep, and sustained MRD-negative responses in patients with newly diagnosed Ph+ ALL, while maintaining a favorable safety profile, and provide important evidence supporting its use in the frontline setting. SAFETY AND PRELIMINARY EFFICACY OF OLVEREMBATINIB (HQP1351) COMBINED WITH LISAFTOCLAX (APG-2575) IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY (R/R PH+ ALL): RESULTS OF A PHASE 1B STUDY Abstract Number: EHA-4691 (PS1473) First Author: Jingliao Zhang, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Key Highlights: This open-label, dose-escalation Phase Ib study evaluated olverembatinib in combination with lisaftoclax in pediatric patients with relapsed/refractory (R/R) Ph+ ALL who are resistant or intolerant to at least one prior TKI. A total of 17 patients were enrolled, with a median age of 13 years, and 40% harbored ABL1 mutations, including T315I . Among nine efficacy-evaluable patients, the combination achieved an overall response rate (ORR) of 88.9%, an MRD-negativity rate of 66.7% (8/12 at cycle 2 day 28), and 93.3% of patients (14/15 at cycle 2 day 28) achieved MMR or better. Both agents were detectable in cerebrospinal fluid (CSF), providing evidence of CNS penetration, and demonstrated activity across ABL1 mutation subgroups. The regimen showed a manageable safety pro no treatment-related deaths. These findings support the potential of this chemotherapy-free oral dual-targeted regimen to induce rapid and deep remissions, and may provide a novel treatment option for pediatric patients with R/R Ph+ ALL. REAL-WORLD EFFICACY AND SAFETY OF LISAFTOCLAX IN MYELOID NEOPLASMS: A MULTICENTER STUDY Abstract Number: EHA-5454 (PF562) First Author: Chen Cao, Qilu Hospital of Shandong University Key Highlights: This multicenter real-world (retrospective) study evaluated the efficacy and safety of the novel BCL-2 inhibitor lisaftoclax in patients with myeloid neoplasms. A total of 30 patients (median age 63) were enrolled, including 25 patients with acute myeloid leukemia (AML, 83%), 3 with myelodysplastic syndromes (MDS, 10%), and 2 with chronic myelomonocytic leukemia (CMML, 7%). In patients with AML, the CR/CRi rate reached 72%, with the highest response observed in the ELN low-risk subgroup (87%). Among patients achieving CR/CRi, the MRD-negativity rate was 61%. The CR/CRi rate was 100% in patients with NPM1 mutations and 83% in patients with IDH2 mutations. Among the three patients with MDS, two achieved CRi. Regarding safety, grade≥3 treatment-emergent adverse events (TEAEs) were primarily hematologic adverse events, including thrombocytopenia (27%), anemia (23%), and neutropenia (20%). Overall safety was manageable. These findings demonstrate promising efficacy and manageable safety of lisaftoclax in the real-world treatment of myeloid neoplasms, particularly AML. CORRELATION OF BASELINE CHARACTERISTICS WITH PROGNOSIS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) TREATED WITH LISAFTOCLAX (APG-2575) IN A PIVOTAL PHASE 2 STUDY Abstract Number: EHA-3984 (PS1713) First Author: Keshu Zhou, Henan Cancer Hospital Key Highlights: This correlative analysis from the pivotal Phase II study (NCT05147467) evaluated associations between baseline characteristics and prognosis in patients with R/R CLL/SLL treated with lisaftoclax. The study enrolled 77 patients with R/R CLL/SLL refractory to BTKis who received lisaftoclax 600 mg once daily. Among 72 evaluable patients, the median progression-free survival (PFS) was 23.9 months and the Independent Review Committee (IRC)-assessed ORR was 62.5%. Further analyses showed that TP53 mutation/del(17p), complex karyotype (CK), and mutations in SF3B1, KIT, BLM, and SETD2 were associated with significantly shorter PFS. Complex karyotype and tumor size were identified as independent risk factors for shorter PFS. These findings demonstrate that lisaftoclax has clinical activity in patients with R/R CLL/SLL refractory to BTKi therapy. Additionally, these data may help to identify patients with poorer prognosis based on baseline risk characteristics, supporting future risk stratification and risk-adapted combination treatment strategies. *Olverembatinib and lisaftoclax are currently under investigation and have not yet been approved by the US FDA. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders. The Company’s first approved product, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an FDA- and EMA-cleared registrational Phase III trial, called POLARIS-2, of olverembatinib for CML, as well as an FDA- and EMA-cleared registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3. The Company’s second approved product, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA- and EMA- cleared GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA- and EMA-cleared GLORA-4 study in patients with newly diagnosed higher risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 29, 2026, the sections headed “Forward-looking Statements” and “Risks Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited where the Company’s ordinary shares are listed it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations: Stella Yang Ascentage Pharma Stella.Yang@ascentage.com +1 (301) 792-6286 Ascentage Pharma IR@ascentage.com +1 (301) 792-6286 Stephanie Carrington ICR Healthcare AscentageIR@icrhealthcare.com +1 (646) 277-1282 Media Relations: Sean Leous ICR Healthcare AscentagePR@icrhealthcare.com +1 (646) 866-4012

Above the scientific discussions and deal talks at ASCO 2026, the dark cloud of geopolitics hovered over the Chicago convention center. In 2017, a little-known company called Nanjing Legend Biotech walked into the ASCO annual meeting at the 11th hour, dropped a 100% objective response rate for a cell therapy that would become Carvykti, and single-handedly put Chinese biotech on the global map. Nearly a decade later, taking the center stage at ASCO 2026, Akeso’s ivonescimab made history by offering the first-ever Chinese data set to command a coveted spot on the plenary session.“We see a lot of sophistication and skill in Chinese companies,” Marjorie Green, M.D., head of oncology global clinical development at Merck Research Laboratories, said in an interview.The maturity of the Chinese biopharma industry is evidenced by the deals it has signed. Through a potential $3.3 billion pact in 2024, Merck secured global rights to a PD-1xVEGF competitor to ivonescimab from China’s LaNova Medicines. The following year, LaNova was acquired by Sino Biopharm in the first full acquisition of an innovative Chinese biotech by a domestic large pharma on record, a milestone widely viewed as evidence of an increasingly mature ecosystem. At ASCO, ivonescimab’s landmark overall survival (OS) win against a PD-1 inhibitor in their respective combinations with chemotherapy in first-line squamous non-small cell lung cancer (NSCLC) was just one of numerous studies of Chinese assets that reshaped the conference’s narrative.In what Natalie Vokes, M.D., of the MD Anderson Cancer Center said “could well be a practice-changing study” if validated in a global trial, Kelun-Biotech’s TROP2 antibody-drug conjugate, sac-TMT, paired with Keytruda, slashed the risk of progression or death by 65% versus Keytruda alone in Chinese patients with previously untreated PD-L1-positive NSCLC. That drug, too, also has been swept into the Merck universe.Even though the study used Keytruda monotherapy as the comparator, Vokes noted on stage that the progression-free survival (PFS) efficacy of the sac-TMT combo compares favorably to historical data for Keytruda plus chemo."I go to bed and wake up with in my mind there are two things, China and AI," Pfizer CEO Albert Bourla said.Opening that same lung cancer session on May 29, Dizal Pharma showed that its small molecule tyrosine kinase inhibitor Zegfrovy improved PFS by 45% compared with chemo among first-line NSCLC patients with EGFR exon 20 insertion mutations, the exact field where Takeda had stumbled with Exkivity. Compared to Johnson & Johnson’s antibody Rybrevant, used alongside chemo, Zegfrovy offers “the advantage of a single oral agent administration,” John Heymach, M.D., chair of thoracic/head and neck medical oncology at MD Anderson, noted during his presentation.The third Chinese asset sharing the same stage, a next-generation RET inhibitor called lunbotinib, also hails from Kelun.“Over the last three years, especially in emerging fields like bispecifics and ADCs, China has become so essential, some are even saying that if a session doesn’t include presentations or data from China, it’s simply not worth attending,” Dajun Yang, M.D., Ph.D., CEO of Ascentage Pharma, said in an interview with Fierce. “In sectors like bispecifics, bispecific ADCs or protein degraders, up to a third of the studies presented are coming out of China.”  The speed engineNew compounds are entering clinical trials in China at an unprecedented speed. In 2015, Ascentage secured five Investigational New Drug (IND) clearances from Chinese regulators across two molecules. At the time, that total IND number ranked third among Chinese biopharmas. Today, China sometimes clears 20 IND approvals in a single week, Yang noted.The sheer volume has caught attention across the Pacific. During a speech to FDA staffers on April 1, then-FDA head Marty Makary, M.D., flagged that China today has four times more phase 1 initiations than the U.S.Paradoxically, China’s IND review timeline is not as fast as the U.S. FDA, Yang observed. Instead, the pace of preclinical lab tests helps set China apart in the speed of the entire IND process. For its BTK degrader candidate APG-3288, Ascentage entered good laboratory practice (GLP) toxicology studies in April 2025 and received FDA IND clearance two days before Christmas—an eight-month process from an IND bid to a regulatory green light.If the GLP work had been done in the U.S., simply waiting in line to launch primate studies could have taken half a year on its own, Yang noted. At ASCO, Ascentage shared phase 1b updates of its olverembatinib, a China-approved third-generation BCR-ABL1 inhibitor and potential competitor to Novartis’ blockbuster Scemblix, in patients with lymphoid blast phase chronic myeloid leukemia (CML) or Ph+ B-cell precursor acute lymphoblastic leukemia, as well as in second-line chronic-phase CML.The drug is commercially partnered with Innovent Biologics in China, while Takeda holds an option to in-license the TKI through a potential $1.3 billion deal signed in 2024. Takeda’s ties with China have been deepening. More recently, the Japanese pharma paid none other than Innovent $1.2 billion upfront for rights to two oncology candidates. One of the programs, a potential first-in-class PD-1/IL-2 bispecific fusion protein called IBI363 (TAK-928), showcased phase 1 proof-of-concept lung cancer data at ASCO 2026. “We actually found that China biotechs currently are just a tremendous source, honestly, of innovation,” Takeda’s oncology R&D head, P.K. Morrow, M.D., told Fierce. “In the past, one might have looked at it as follow-on molecules, and that is completely untrue now.” ‘Their second step’With Takeda, Innovent will co-develop and co-commercialize IBI363. Until recently, this deal structure was not very common compared with early research collaborations, pure licensing arrangements or asset purchases between Chinese biotechs and large multinational pharmas. Similar collaboration terms can also be found in Bristol Myers Squibb’s $15.2 billion, broad partnership with Hengrui Pharma.On the eve of ASCO 2026, Innovent stole the limelight with its own massive multi-asset partnership with Pfizer, which also includes co-development and co-commercialization terms around four assets.“These are clear votes of confidence on the abilities of at least these specific companies—Hengrui and Innovent—to conduct development and generate assets at a similar level to that of their partner multinational pharmas,” Helen Chen, global sector co-head for healthcare and a Greater China managing partner of L.E.K. Consulting, told Fierce.Pfizer examined Innovent’s drug development track record and their discovery engine and was “very excited in what we saw about the quality,” Johanna Bendell, M.D., Pfizer’s chief development officer of oncology, said in an interview.Bendell’s boss is perhaps blunter. “I go to bed and wake up with in my mind there are two things: China and AI,” Pfizer CEO Albert Bourla said in a podcast aired May 20, before quickly adding, “and politics, unfortunately.”Despite the vote of confidence, Innovent CEO Michael Yu, Ph.D., acknowledges that Innovent’s internal capabilities are not yet strong enough to support a solo act on the global market. “That’s why we have to find a company that is willing to take this journey together with us,” Yu told Fierce.The four assets to be co-developed under the Pfizer pact also drew interest from other companies, enabling Innovent to press for the co-development terms, Yu said. For IBI363, Innovent even left higher bids on the table to choose Takeda because the partner, besides global oncology know-how, is willing to work under a co-development framework, he said.For his part, Bourla has already sensed that in deal talks with Chinese companies, Western players no longer hold an overwhelmingly dominant position. “They are focusing on early right now, because they can’t have global clinical development teams yet, and they don’t have commercial development teams yet,” he said during the podcast with Norges Bank Investment Management CEO Nicolai Tangen. “So I’m sure that on the early stage, they would be very quickly better and more productive than us within two years. Then it comes to, they need to transition to being able to take those molecules and bring them to the world alone rather than together with us. And I think that will be their second step.” A China data question? BMS had been a believer in Chinese innovation even before teaming up with Hengrui. At ASCO, the New Jersey pharma’s chief medical officer, Cristian Massacesi, M.D., touted the broad potential of a first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), which the pharma giant bought from China’s Sichuan Biokin Pharmaceutical for $800 million upfront. In two phase 3 trials run by Biokin in China, the novel ADC bested chemo on both PFS and OS in patients with previously treated triple-negative breast cancer and esophageal cancer, separately. BMS has now started to conduct registrational studies of the asset globally.But amid the rounds of applause at ASCO and the stream of multibillion-dollar transactions, doubts and uncertainties linger. Despite a positive OS readout from Harmoni-6 that exceeded expectations, Akeso’s stock price first shot up, then dropped Monday as its findings’ translatability from China to a global population came into question.“It’s not necessarily a China question versus a non-China question,” Merck’s Green said. “It has to do with, when you do studies in more homogeneous settings or in smaller groups. There's similar questions to me about, how do things translate when you take it into a broader global study where you’ve got more heterogeneity of care?”Özlem Türeci, M.D., co-founder and chief medical officer of BioNTech, doesn’t think data reproducibility is a China question, either.“China's data is as good as data from any region. It’s also being adopted,” she said in an interview with Fierce. “The point is, if you want to have a global development program with global approvals and global launches, you have to conduct global studies. And that’s the reason why at some point regional studies or regional programs have to move into global and have to show that they can be globally confirmed.”BioNTech has its own rival to ivonescimab, the PD-L1xVEGF bispecific pumitamig, which it initially in-licensed, then fully acquired after buying out China’s Biotheus. BMS quickly signed on to the drug with a co-development and co-commercialization deal. At ASCO, the drug offered the first look at a global data set within the PD-(L)1xVEGF class in first-line NSCLC. Meanwhile, another Chinese asset could give BioNTech—which quickly ascended to global fame as a COVID vaccine maker—its first commercial oncology product. Licensed from China’s Duality Biologics, the HER2 ADC trastuzumab pamirtecan is moving toward an FDA filing after a positive readout in previously treated endometrial cancer. BioNTech got trastuzumab pamirtecan and another ADC from Duality for $170 million upfront in 2023, a time when Chinese biotechs were reeling from a pandemic crunch. Today, as asset quality rises, Chinese drug candidates may be harder to pocket for buyers despite their abundance. In the words of Evaluate analyst Mark Lansdell, China is “not a bargain basement anymore.” While the number of total cross-border licensing deals of Chinese biotech products increased by 120% from 2022 to 2025, the total upfront value jumped about 400%, from $1.1 billion in 2022 to $5.6 billion last year, according to Evaluate.  The geopolitical shadowAbove the scientific discussions and deal talks, the dark cloud of geopolitics hovered over the Chicago convention center. Going forward, accessing China's biotech assets could become more difficult for U.S. companies as calls for restricting cross-border deals through the COINS Act grow louder. To some, the solution to maintaining the U.S.’ leadership in biotech is blocking China, along with any collaborations with the country. But others, like Pfizer’s Bourla, have pushed back on this mentality.“[The U.S.] should stop trying with all the heart and brains that they have to put 80% of their effort [on] how to slow down China,” Bourla said during the podcast. “Very big mistake. Because it’s a waste of resources and brain power because you will never slow them down. The genie is out of the bottle. We should put 80% of our focus and effort [on] how to become better than China.”From the U.S. biotech industry’s side, Bruce Booth, partner at Atlas Venture, echoed the sentiment in a June 2 blog post, framing China’s rise as “more opportunity than threat” and “a healthy forcing function to raise the game for everyone.” Still, beneath the big headlines, the friction was felt on the ground at ASCO.“China biotech presence in ASCO [this year] is not as many as the peak years in my memory,” observed Leon Tang, Ph.D., founder of the business development consultancy InScienceWeTrust BioAdvisory, pointing to rising travel costs and visa uncertainty as common concerns.Yet, the pioneers of the space remain undeterred. As more Chinese drugs vie to stage their own Carvykti moment, Frank Fan, M.D., Ph.D., the scientific mind behind the cell therapy’s breakthrough, returned to ASCO this year with a new proposal: an off-the-shelf CAR-T platform with potential for unprecedented production scalability without the need for gene editing. His new company, Wondercel Therapeutics, debuted early data from four patients with diffuse large B-cell lymphoma, showing early signs that its candidate can avoid premature clearance by the host immune system while achieving CAR-T expansion at levels similar to that of autologous CAR-T inside a patient’s body.For his new platform, Fan again hopes to deploy the same partnership model that built Legend—even if a COINS Act expansion would mean a deal with a U.S. company like Carvykti’s partner J&J would not be possible.“Even if obstacles do arise in the future, we still have Europe, Japan and other regions to partner with,” Fan said. “As long as we maintain innovation, and as long as international intellectual property laws remain intact, we remain confident.”Editor's note: Zoey Becker and Darren Incorvaia contributed reporting.