PharmaFocus Today – Page 40 – media

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
- 163
- 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
- 156
- 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
- 148
- 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
- 110
- November 5, 2025
to invest $3 billion in the Netherlands to build a new manufacturing facility and expand its oral drug production capacity.

November 3rd, ReiThe company announced plans to acquire Caterpillar in the Netherlands.Vic is investing $3 billion to build a new manufacturing facility to expand its oral drug production capacity and improve its global supply chain. Eli Lilly stated that the facility will be responsible for producing its first oral small-molecule GLP-1 receptor agonist, orforglipron. The company plans to submit applications for the drug’s use in obesity treatment to regulatory agencies worldwide by the end of this year. Eli Lilly also stated that the investment plan will create 500 high-paying jobs in South Holland, targeting highly skilled engineers, scientists, operations specialists, and laboratory technicians. In addition, approximately 1,500 new jobs are expected during construction. The project is scheduled to begin next year, with final implementation depending on the completion of government permits and local approvals. https://finance.eastmoney.com/a/202511033553774014.html
- Source: drugdu
- 179
- November 4, 2025
Pfizer files antitrust lawsuit to block Novo Nordisk’s acquisition of Metsera.

American pharmaceutical company PfizerFor Metsera and Novo NordiskA lawsuit has been filed against the two weight-loss drug companies .The latest merger agreement reached with the property developer violates U.S. federal antitrust laws. This is Pfizer ‘s second lawsuit in four days, aimed at preserving its acquisition agreement that was unexpectedly disrupted by Novo Nordisk . According to a complaint filed by Pfizer in the U.S. District Court for the District of Delaware on Monday, Pfizer alleges that Novo Nordisk, the maker of Ozempic , is planning a proposed acquisition of U.S. biopharmaceutical company Metsera, which would further solidify its leadership in the field of obesity treatments by killing a smaller competitor. The background to this event is that in September of this year, Pfizer announced that it had agreed to acquire Metera for $47.50 per share in cash, corresponding to an enterprise value of approximately $4.9 billion. If certain research and development targets are met, Pfizer will pay an additional $22.50 ...
- Source: drugdu
- 128
- November 4, 2025
Livzon Pharmaceutical’s innovative quadrivalent recombinant protein influenza vaccine completes Phase I clinical trial with first cohort vaccination

Shanghai Securities News China Securities(Reporter Zhang Xue) On October 30, Livzon Pharmaceutical Group announced that its developed quadrivalent recombinant protein…influenzaThe LZSN2401 vaccine recently completed vaccination of the first cohort of subjects in its Phase I clinical trial, and subsequent cohort enrollment has successfully commenced. This vaccine is the world’s first adjuvanted quadrivalent recombinant protein influenza vaccine, and its development deeply integrated artificial intelligence.The technology, along with a significant breakthrough in adjuvant systems, promises to provide better protection for influenza prevention and control, especially for the elderly. According to the company, in the development of LZSN2401, Livzon Pharmaceutical applied artificial intelligence technology systems to process development and analysis method optimization, which greatly improved R&D efficiency and product quality, fully demonstrating the company’s strategic direction of using artificial intelligence to promote R&D efficiency in recent years. Qualcomm utilizes AI algorithms to analyze key process parameters.Through quantitative simulation and intelligent screening, the team optimized a process route that would have taken more than six months under the traditional model ...
- Source: drugdu
- 102
- November 4, 2025
A recent study published in the international academic journal *Vaccines* shows that Sinovac’s varicella vaccine has a better safety profile than the control vaccine.

Reporters have learned that the internationally renowned academic journal *Vaccines* recently published a research paper entitled “Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Healthy Children Aged 12 to 15 Months.” This study is the first to use Beijing Sinovac Biotech…Sinovac Biotech’s (hereinafter referred to as “Sinovac”) varicella live attenuated vaccine was compared head-to-head with another control vaccine that has passed WHO prequalification. The results showed that Sinovac’s varicella live attenuated vaccine met the non-inferiority standard for immunogenicity and had better safety than the control vaccine. This study was a randomized, double-blind, positive-control, non-inferiority phase III clinical trial conducted at San Juan de Dios Hospital in the Philippines. A total of 484 healthy children aged 12 to 15 months were enrolled and randomly assigned to receive either one dose of Sinovac varicella attenuated live vaccine (239 cases) or control vaccine (245 cases). The primary evaluation factor was the varicella-zoster ...
- Source: drugdu
- 133
- November 4, 2025
CAR-T therapy, a “sky-high priced cancer treatment,” may see a breakthrough in commercial insurance pricing negotiations this year.

At approximately 3 PM today, during the on-site negotiations for the 2025 National Reimbursement Drug List and the discussion on innovative drugs covered by commercial insurance…At the price negotiation meeting, representatives from HeYuan Biotech, unable to hide their joy after concluding price negotiations, told reporters from Cailian Press, “We’ve reached an agreement,” but the final result will still be subject to the final announcement by the National Healthcare Security Administration. This means that CAR-T drugs, including HeYuan Biotech’s Nakiorenzai injection, are expected to achieve a breakthrough in this year’s price negotiations for innovative drugs covered by commercial insurance. HeYuan Biotech’s Nakiorenzai injection was approved for marketing in 2023, and five CAR-T drugs, represented by Nakiorenzai, have all passed the preliminary review for the innovative drug list covered by commercial insurance this year. Due to its high price, CAR-T therapy has failed to enter the “threshold” of national medical insurance negotiations for the past four years. ...
- Source: drugdu
- 116
- November 3, 2025
Hanyu Pharmaceuticals returned to profitability in the first three quarters, with overseas markets becoming the engine of growth.

Recently, Shenzhen Hanyu Pharmaceutical Co., Ltd.According to the third-quarter report of 2025 disclosed by Hanyu Pharmaceutical Co., Ltd. (hereinafter referred to as ” Hanyu Pharmaceutical “, 300199.SZ), the company suffered a net loss of 74.1171 million yuan in the quarter, a year-on-year decrease of 203.18%. However, the net profit for the first three quarters showed a significant increase, turning a profit compared to the same period last year. At the same time, the company’s cash flow continued to improve. According to the Economic Information Daily, Hanyu Pharmaceutical has suffered losses for three consecutive years, but its performance has continued to grow this year. It is currently accelerating its layout of peptide drugs, and overseas markets have become its growth engine. Net profit turned around year-on-year in the first three quarters Founded in April 2003, Hanyu Pharmaceutical is a national high-tech enterprise specializing in the research, development, production, and sales of ...
- Source: drugdu
- 138
- November 3, 2025

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.