PharmaFocus Today – Page 15 – media

Merck receives $700 million investment from Blackstone to accelerate the development of Luchakzatuzumab.

　　Beijing News (Reporter Wang Kala) November 4, Merck…The company announced a $700 million R&D funding agreement with Blackstone, which will be used for the global development of its core ADC asset, sacubitril-TMT (sac-TMT). At a time when the ADC field is becoming a global focus of pharmaceutical innovation , this collaboration between a multinational pharmaceutical company and a capital giant not only demonstrates a high level of recognition of the commercial value of sacubitril-TMT, but also signifies a major milestone for innovative drugs in China.Driven by a dual approach of “global R&D + capital empowerment,” it is accelerating its entry into the ranks of global blockbuster drugs. 　　Under the terms of the agreement, Blackstone will pay Merck $700 million specifically to fund a portion of the development costs for SAC-TMT projected to be incurred in 2026. Merck stated that this agreement will help the company fully realize the potential of ...
- Source: drugdu
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- November 6, 2025
Taienkang’s Class 1.1 innovative drug CKBA achieves new progress, with breakthroughs in Alzheimer’s disease research.

　　On November 5th, ” Tainkang”Class 1.1 innovative drugsA press conference was held in Ma’anshan City, Anhui Province, to announce the publication of innovative research findings on CKBA for the treatment of Alzheimer’s disease in the top international journal “Nature Aging”. Taiencon announced the official launch of its preclinical research on CKBA for Alzheimer’s disease. 　　”With the aging population, the number of Alzheimer’s disease (AD) patients in China is continuing to grow, and there is an urgent need for a new theoretical system and drug solutions.” When talking about the initial motivation for entering the Alzheimer’s disease field, Zheng Hanjie, Chairman and General Manager of Taincon , said that CKBA has shown excellent potential in the AD field, and the company is full of confidence in developing CKBA products. 　　Accelerating the development of the Alzheimer’s disease sector 　　Data shows that Alzheimer’s disease, as the most common neurodegenerative disease in the world, ...
- Source: drugdu
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- November 6, 2025
Sanofi’s innovative targeted nanobody drug, Kebeli, has been approved in China.

On November 5th, SanofiAnnouncement of its innovative drugCablivi (caracizumab for injection) has been officially approved by the National Medical Products Administration (NMPA) for use in combination with plasma exchange and immunosuppressive therapy.Acquired thrombotic thrombocytopenic purpura (aTTP, also known as immune-mediated thrombotic thrombocytopenic purpura) in adults and adolescents aged 12 years and older weighing at least 40 kg. https://finance.eastmoney.com/a/202511053556137255.html
- Source: drugdu
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- November 6, 2025
FDA Approves Kygevvi Becoming the First Treatment for Thymidine Kinase 2 Deficiency

UCB has announced FDA’s approval of Kygevvi (doxecitine and doxribtimine) for the treatment of adults and pediatric patients living with thymidine kinase 2 deficiency (TK2d) and is the first and only approved treatment for these patients living with TK2d.1 “The approval of doxecitine and doxribtimine represents a pivotal moment for the TK2d community who previously had no FDA-approved treatment options for this rare genetic mitochondrial disease beyond supportive [palliative] care,” said Donatello Crocetta, chief medical officer at UCB. “We extend heartfelt thanks to the patients, families and friends, advocates, healthcare providers and dedicated clinical trial teams who have partnered with us on this important journey.” Why did FDA approve Kygevvi? Kygevvi’s approval is based on safety and efficacy data collected from a Phase II clinical study, two retrospective chart review studies, and an expanded access use program.1 In total, the studies included 82 various patients treated with Kygevvi or pyrimidine ...
- Source: drugdu
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- November 6, 2025
Pfizer COVID-19 Vaccine Sales Tumble After Government Guidance on the Shots Narrows

The fall COVID-19 vaccine season is starting slowly for Pfizer, with U.S. sales of its Comirnaty shots sinking 25% after federal regulators narrowed recommendations on who should get them. Approval of updated shots also came several weeks later than usual, and Pfizer said Tuesday that hurt sales as well. Many Americans get vaccinations in the fall, to protect against any disease surges in the coming winter. Experts say interest in COVID-19 shots has been declining, and that trend could pick up this fall due to anti-vaccine sentiment and confusion about whether the shots are necessary. The Centers for Disease Control and Prevention last month stopped recommending COVID-19 shots for anyone, instead leaving the choice up to patients. The government agency said it was adopting recommendations made by advisers picked by U.S. Health Secretary Robert F. Kennedy Jr. Before this year, U.S. health officials — following the advice of infectious disease ...
- Source: drugdu
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- November 6, 2025
Baiyang Pharmaceuticals and Jeterbeline join hands to expand the human serum albumin market

On November 4th, a reporter learned from Baiyang Pharmaceuticals…It has been learned that the company signed a deepened cooperation agreement with CSL, a leading global blood products company, on the same day. According to the agreement, Baiyang Pharmaceutical will acquire Ambow, a human serum albumin product from CSL.Exclusive promotion, sales and distribution rights for MI® in specific markets in China. It is understood that this collaboration represents a further strengthening of the partnership between the two parties, building upon their cooperation in the retail market in 2018. Public information shows that human serum albumin can be used for emergency treatment of hypovolemia, treatment of significant hypoalbuminemia, treatment of neonatal hyperbilirubinemia, and as an adjunct therapy for acute respiratory distress syndrome, cardiopulmonary bypass, and plasma exchange in special types of hemodialysis. It is a commonly used drug in clinical emergency and critical care. According to data from Moshang Consulting, the Chinese market for human serum ...
- Source: drugdu
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- November 5, 2025
Plans to Advance Multiple Phase III Lung Cancer Phase II Clinical Trials. (This is part of a larger effort to validate the efficacy of PD-L1 ADC.)

Science and Technology Innovation Board Daily, November 3 (Reporter Xu Hong) – “When the HLX43 project was first launched, not many people were optimistic about this direction. But drug development cannot follow the crowd; we must see what others cannot. Why do so many cancer patients still respond when they use PD-1 again after having previously used it? It was based on this observation that I pushed the team to follow up on this direction.” During a media exchange on November 2, Dr. Zhu Jun, Executive Director and CEO of Henlius Biotech (02696.HK), reviewed the starting point of HLX43’s research and development. Today, this project, which started more as a “trial and error” experiment, is beginning to validate its initial scientific assumptions step by step as clinical research progresses. HLX43 is an antibody-drug conjugate (ADC) that targets PD-L1. Its mechanism of action combines the dual functions of immune checkpoint inhibition ...
- Source: drugdu
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- November 5, 2025
Baili Tianheng’s HER2 ADC drug T-Bren receives Breakthrough Designation for HER2-positive gastric cancer

On November 4th, Baili Tianheng(688506) announced that its independently developed innovative biological drug T-Bren (HER2ADC) has been included in the Breakthrough Therapy List by the Center for Drug Evaluation of the National Medical Products Administration. It is indicated for patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed first-line anti-HER2 therapy and first-line standard chemotherapy. The application date for this drug is September 17, 2025, registration category 1, and acceptance number CXSL2200209. T-Bren is an innovative ADC targeting HER2 with best-in-class potential. Currently, 14 clinical trials are underway both domestically and internationally, including 5 Phase III trials, 1 Phase II/III trial, 2 Phase II trials, 3 Phase I/II trials, and 3 Phase I trials, covering multiple indications. In the first three quarters of 2025, Baili Tianheng achieved revenue of 2.066 billion yuan and net profit attributable to the parent company of -495 million yuan. https://finance.eastmoney.com/a/202511043554798583.html
- Source: drugdu
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- November 5, 2025
HP515 Phase II Clinical Trial Completes First Batch of Participant Enrollment

Haichuang Pharmaceutical disclosed after trading on November 4 that the first batch of participants were recently enrolled in the Phase II clinical trial of its independently developed HP515 drug, which is intended to treat metabolic-associated steatohepatitis (MASH). Currently, there are no similar target products approved for marketing in China. The announcement indicates that HP515 tablets are an orally administered, highly selective THR-β (thyroid hormone receptor β subtype) agonist independently developed by Haichuang Pharmaceuticals. HP515 tablets directly act on THR-β to activate downstream gene transcription, thereby enhancing hepatocyte lipid metabolism activity, improving liver fat metabolism, and reducing lipotoxicity to improve metabolic-associated steatohepatitis (MASH). HP515 was approved by the China National Medical Products Administration (NMPA) for the treatment of metabolic steatohepatitis (MASH) in August 2024 and by the U.S. Food and Drug Administration (FDA) for the same purpose in September 2024. Recently, Haichuang Pharmaceuticals has completed the Phase I clinical trial of ...
- Source: drugdu
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- November 5, 2025
FDA Issues Safety Alert for Radiofrequency Microneedling

The U.S. Food and Drug Administration (FDA) is warning consumers, patients and healthcare providers about the potential risk for serious complications from radiofrequency (RF) microneedling procedures. RF microneedling devices are commonly used to improve skin appearance of the face and neck — often referred to as “resurfacing,” “tightening” or “rejuvenation” to treat issues like wrinkles. The technology works by using an array of tiny needles (microneedles) to deliver RF energy and heat into the skin. This heat is intended to cause controlled changes in the tissue, promoting new collagen growth, according to the FDA. However, the FDA has received numerous reports of serious and potentially permanent injuries related to the microneedling procedure. The adverse events reported to the agency include: Severe burns Permanent scarring Fat loss (diminishing facial volume) Physical disfigurement Nerve damage These reported injuries have occasionally required follow-up ...
- Source: HealthDay
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- November 5, 2025

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