Pembrolizumab

HONG KONG, Sept. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) has recently announced the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination therapy, for the first-line treatment of advanced biliary tract cancer (BTC) (AK112-309/HARMONi-GI1). This Phase III trial is being conducted in China. Ivonescimab has previously shown significant positive results in the randomized, double-blind, controlled Phase III study (HARMONi-2), where it was compared head-to-head with pembrolizumab. These results led to its approval as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC), marking its second approved indication. In addition, the Phase III trial of ivonescimab in combination with chemotherapy compared to tislelizumab combined with chemotherapy as a first-line treatment for squamous NSCLC, also delivered significant positive outcomes. These results highlight ivonescimab's strong clinical breakthroughs. Whether compared to PD-1 monotherapy, PD-1 plus chemotherapy (current standard therapies for various cancers), or VEGF-related treatments, ivonescimab has consistently demonstrated its ability to drive clinical innovation. Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings: Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints): First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial) First-line squamous NSCLC (versus tislelizumab + chemotherapy) NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies) First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy) First-line PD-L1-high expressing NSCLC (versus pembrolizumab) IO-resistant NSCLC Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT) Phase III trials for core immuno-oncology indications (first-line therapy ): First-line biliary tract cancer (versus durvalumab + chemotherapy) First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab Phase III trials for cold tumors and more: First-line triple-negative breast cancer (TNBC) First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases) First-line pancreatic cancer Additional global Phase III trials are in advanced stages of planning An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data that enable rapid transition to further registrational studies worldwide. Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy. For context, pembrolizumab (anti-PD-1) is approved for over 40 oncology indications, and bevacizumab (anti-VEGF) for more than 10. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab worldwide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Welcome to another edition of Endpoints Weekly, and happy Labor Day weekend! I’ve returned from vacation and am ready to help you get your weekend started. Let’s get into the headlines. We had a lot of news out of Washington, DC this week, including growing turmoil at the CDC, where the Trump administration pushed out Director Susan Monarez just a few weeks after she was confirmed by the Senate. Reports indicated that HHS Secretary Robert F. Kennedy Jr. pressured Monarez to change the agency’s guidance on Covid-19 vaccines. Read more below on all the updates from the nation’s capital. Elsewhere, we had a story from Jared Whitlock this week about how Scripps is shaking up its business model to reduce its dependence on government funding. Novartis also made a deal with the inventor of Eisai and Biogen’s Alzheimer’s drug Leqembi, while Merck outlined the strategy for its $5 billion HIV business. And biotech correspondent Kyle LaHucik took a look at the emerging MC4R landscape. Have a great holiday weekend! — Max Gelman Susan Monarez was pushed out of her role as CDC director, weeks after being confirmed. While the exact reason wasn’t immediately clear, lawyers saying they represent Monarez initially claimed in a social media post that she had not officially been fired and would not resign, Endpoints’ Alexis Kramer and Max Bayer wrote . The Washington Post, which first reported the news, said Monarez had refused to resign after pressure to change vaccine policy. HHS announced in a social media post that Monarez is no longer CDC director, and said Secretary Robert F. Kennedy Jr. “has full confidence in his team.” Other CDC leaders have resigned, according to the Post and other media reports, including CDC chief medical officer Debra Houry and National Center for Immunization and Respiratory Diseases Director Demetre Daskalakis. The Post reported that HHS Deputy Secretary Jim O’Neill has been tapped as acting CDC leader. 💰A decade ago, Scripps Research’s financial model looked much different. The nonprofit once got 70% of its funding from government grants. Now that share is 30%, Jared Whitlock reported this week. The organization is pushing discoveries into clinical trials and launching a fund backed by private investors. The reinvention has left Scripps better positioned than other research institutes to withstand recent science funding cuts — and it’s attracting attention from other research institutions looking for ways to shore up their finances. “We as nonprofits need to start thinking more broadly about how we fund and grow our impact than simply relying on federal funding and philanthropy,” Scripps CEO Peter Schultz said in an interview. Read more about Scripps’ model here. 🔬 A growing number of drugmakers is focusing on the melanocortin 4 receptor, or MC4R, one of the most genetically validated pathways in weight control. Superluminal Medicines, Deep Apple Therapeutics and Congruence Therapeutics are all planning to move MC4R-targeting drugs into the clinic next year. Rhythm CEO Alastair Garfield said MC4R is part of a system “designed to be able to control your hunger, your energy expenditure and your body weight.” While it could have implications in weight loss, Pfizer appears to be going for a different outcome. The pharma giant quietly launched a Phase 1 study on the US clinical trials registry last month to treat older adults with unintended weight loss and/or people at risk of malnutrition, according to the database. Check out Kyle LaHucik’s story for the details. 🤝 Novartis is teaming up with BioArctic to help solve the mysteries of the blood-brain barrier. The arrangement will pair BioArctic’s BBB technology with an in-house antibody from Novartis to create a new drug. The deal is worth $30 million upfront and up to $772 million in biobucks, and Novartis has an option for a global license. Much still remains unclear about the partnership, since neither company said which disease they’re going to tackle. But the program will be aimed at one drug target in CNS and neurological disorders. BioArctic, a Swedish biotech that invented Leqembi, has also teamed up with Eisai and Bristol Myers Squibb on BBB pacts in the last 18 months. Merck has taken several steps to position its HIV business as a potential plug for its upcoming Keytruda-sized hole in revenue in recent weeks. CEO Rob Davis said the company’s HIV portfolio could amount to a $5 billion opportunity, and researchers are preparing a Phase 3 program for a once-monthly PrEP tablet. Some analysts, however, remain skeptical that Merck can compete with more established presences in the field, such as Gilead and ViiV. Keytruda, the best-selling drug in the world, recorded sales of $29.5 billion last year, and it’s expected to surpass $30 billion in 2025. The drug’s patent expires in 2028. Kyle LaHucik has more you can read here .