Biotheus, Inc.

Unexpectedly catapulted into global fame as a COVID-19 vaccine maker, BioNTech is on the verge of returning to its oncology roots with potentially its first commercial cancer drug. Yet, to Chief Commercial Officer Annemarie Hanekamp, the upcoming launch is less of a standalone milestone than a strategic springboard for a far more critical pipeline product. Backed by positive phase 2 data and an ongoing confirmatory phase 3 trial, BioNTech is readying its Duality Biologics-partnered antibody-drug conjugate (ADC) trastuzumab pamirtecan (T-Pam) for submission with the FDA for previously treated HER2-expressing endometrial cancer. If approved, the drug will compete with AstraZeneca and Daiichi Sankyo’s blockbuster HER2 ADC, Enhertu, which boasts a pan-tumor indication. Challenging the market leader, however, is not BioNTech’s end goal for T-Pam. “This is not about competing head to head with Enhertu and overtaking them,” Hanekamp said in a recent interview with Fierce Pharma. “We’re very realistic, and we know in the oncology space, first-mover advantage matters. They’ve been in the market for a while, it’s an amazing drug, and we don’t claim to be all that differentiated versus Enhertu.” Instead, Hanekamp views T-Pam as a “strategic launch,” an exercise to “run water through the pipes” and test BioNTech’s commercial infrastructure in oncology. “We’ve never launched [in oncology] before, and launching is not just building a commercial organization,” she explained. “It’s a mindset. It’s building the muscle across all the functions to become commercial-ready.” For BioNTech, that operational reset involves right-sizing its manufacturing footprint. By cutting idle capacity in the vaccine space, the company can reallocate resources to its immediate priorities, putting advancing its late-stage pipeline front and center, Hanekamp noted. The evolution also involves the planned departure of its two researcher founders, CEO Uğur Şahin, M.D., and Chief Medical Officer Özlem Türeci, M.D. “You see this with all founder-led biotechs that grow into a certain stage that the founders ultimately transition,” Hanekamp observed. Ultimately, all the build-out is meant to help polish a crown jewel: pumitamig , a PD-L1xVEGF bispecific antibody partnered with Bristol Myers Squibb. Years ago, Şahin and Türeci had the foresight to tap into innovations from China before the broader industry caught on. BioNTech first licensed pumitamig from China’s Biotheus in 2023 before fully acquiring the firm the next year. Today, the drug is billed as a potential next-generation immuno-oncology backbone for its new owners, anchored by what is so far the most expansive global phase 3 program in the highly competitive PD-(L)1xVEGF class. Thanks to BMS’ experience in cancer immunotherapy and the deal's co-commercialization framework , Hanekamp said the alliance is ready to launch pumitamig in the U.S. right away if needed. “But as BioNTech, it’s our goal to also build that muscle,” she said. BioNTech and BMS maintain a very flexible partnership, allowing each party to explore combinations independently, Hanekamp noted. While novel combos are not part of the first wave of nine global pivotal trials currently underway for pumitamig, BioNTech is pursuing this strategy for the second wave, which will then require that commercial muscle of its own. “We’re still all about the novel combinations with the three platforms,” Hanekamp said, pointing to the firm’s targeted therapies like ADCs, immunomodulators and its signature mRNA platform. Beyond the U.S., BioNTech and BMS have already started commercial planning for pumitamig in Europe, and the partners are “going through the strategic evaluation” to define their blueprint in Japan, according to Hanekamp. Before pumitamig reaches the market, BioNTech could have a second oncology launch in the OncoC4-partnered CTLA-4 agent gotistobart . A pivotal readout from the phase 3 Preserve-003 trial in second-line squamous non-small cell lung cancer is expected this year. Unlike T-Pam, where the launch is “not about the revenues,” gotistobart, if successful, could address an unmet need and add substantial growth to BioNTech’s topline, Hanekamp said. Gotistobart is poised to bulk up BioNTech’s commercialization muscle, too, ahead of pumitamig’s arrival. Rosetta Lung-01, the first global phase 3 readout expected for pumitamig, is in small cell lung cancer. Meanwhile, the all-important Rosetta Lung-02 trial in first-line NSCLC and Rosetta Breast-01 in triple-negative breast cancer (TNBC) are on track to report results the following year in 2029. Hanekamp’s commercial team plans to leverage the market footprints of its earlier launches to establish clinical relationships for pumitamig. Specifically, the company sees a major overlap between prescribers who treat endometrial cancer—the planned initial indication for T-Pam—and those who treat TNBC. Similarly, the lung cancer specialists BioNTech will engage for gotistobart are the same ones it will need to target for pumitamig. “For me, there’s one priority, and that’s relationships,” Hanekamp said. “Once you’re launching out of the gate, you don’t want to have a sales rep needing to build those relationships,” she explained. “If it takes six months to get your first approved meeting with a physician, then you’re six months too late.” RELATED: ASCO: In next-gen IO race, BioNTech/BMS and Pfizer are divided on overall survival approach Of course, any marketing efforts behind pumitamig will have to be based on data. In a bid to accelerate the drug’s regulatory timeline in first-line NSCLC, BioNTech recently tweaked Rosetta Lung-02’s design to make progression-free survival its sole primary endpoint. That means, by the time pumitamig enters that market, it may lack statistically significant data on the key secondary endpoint of overall survival, potentially putting it at a commercial disadvantage. Hanekamp was involved in making that protocol adjustment, and she said the commercial team is “fully supportive of this approach.” “Lung cancer is one of the bigger indications. It is important to be part of the first wave,” she said. “We know the timelines for the competition , so we are constantly evaluating, is there an opportunity for us to speed up to bring these drugs to patients earlier, and therefore also be a little bit more competitive?” If OS is not mature enough to be included in pumitamig’s FDA label—which would bar sales reps from promoting it—Hanekamp argues that a more comprehensive data package will still be available in the public domain once it’s presented at medical meetings. Even as the commercial infrastructure is meant to lay the groundwork for a much bigger product, Hanekamp stressed that the inaugural team will be right-sized. “There’s a foundation that I need to build,” the commercial chief said. “Once I have built that capability, then I can scale. Scaling, it’s still effort, but scaling is less complex than to build the capability from scratch.”

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.

It’s becoming Hengrui Pharma’s world, and some Western drugmakers are just living in it. China’s largest pharma company, which boasts one of the biggest pipelines in the industry, has lined up Bristol Myers Squibb as its latest partner in a deal worth up to $15.2 billion . The total value of the Tuesday pact marks one of the largest East-to-West cross-border deals in industry history. But the upfront payments aren’t as large as some in recent memory. The alliance comes with $600 million upfront from Bristol Myers, plus $175 million on the first anniversary and another $175 million in 2028, Hengrui said. The total deal value rivals the up to $12 billion tie-up that Hengrui forged with GSK last year. But that doesn’t reach the roughly $18.5 billion outlay that AstraZeneca inked with CSPC Pharmaceutical for obesity and other metabolic drugs in January. The BMS-Hengrui broad-based partnership involves a total of 13 programs: Four are oncology and hematology assets from Hengrui; four are immunology programs from Bristol Myers; and the remaining five will be jointly discovered and developed by the pair. A Bristol Myers spokesperson declined to disclose the names of the assets, and it wasn’t immediately clear how clinically advanced they were. The spokesperson said the agreement involves modalities such as multi-specific and targeted protein degradation platforms. BMS chief research officer Robert Plenge said in a press release that the company and Hengrui’s “complementary capabilities across geographies” will help the duo “accelerate early clinical learning and make informed decisions that support driving top tier growth in the next decade and, ultimately, our mission to deliver medicines that help patients prevail over serious diseases.” It’s one of the only major China deals that Bristol has done in recent history. The New Jersey drugmaker’s major PD-1xVEGF bet with BioNTech derives from China’s Biotheus . Other than that, BMS has disclosed few China deals relative to its pharma peers, some of which have gone on shopping sprees in the bustling R&D region. Hengrui’s shares were up nearly 5% on the Hong Kong and Shanghai stock exchanges following the deal disclosure. Its BMS collaboration and licensing arrangements are slated to close in the third quarter. In the deal, Hengrui can co-develop and “conduct certain commercialization activities globally” with its new partner. That marks one of the clearest signals yet that a Chinese pharma company wants to go global with its pipeline and engrain itself in commercial operations in other regions of the world. Hengrui chief strategy officer Frank Jiang previously told Endpoints News the company has a desire to “have Hengrui-branded products sold in the US [and] the EU.” Hengrui is one of the top 25 global pharma companies by market value, and it’s among a cohort of Chinese drugmakers eyeing a global mission , partly by way of partnerships . Jiang and team have collected a handful of major deals in the past couple years. Merck, GSK, Kailera Therapeutics, Braveheart Bio and Aiolos Bio are some of the highlights. The BMS deal now extends a hot streak for those alliances. Obesity-focused Kailera had the largest biotech IPO on record last month. Braveheart, meanwhile, had key cardiology clinical data earlier this week. Editor’s note: This story was updated to include a detail from a Bristol Myers Squibb spokesperson about the modalities involved in the deal.