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Henlius’ biosimilar HLX17 receives FDA approval for clinical trials, entering the over $30 billion market

On September 8, Henlius Biosciences (02696) announced that it received approval from the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial of its independently developed pembrolizumab biosimilar, HLX17, in patients with various resected solid tumors. The company plans to conduct this international, multicenter clinical trial in the United States once conditions permit. The potential indications of HLX17 include melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair gene-deficient tumors and gastric cancer. According to relevant information, in 2024, the global sales of pembrolizumab will be approximately US$32.056 billion. Source：https://finance.eastmoney.com/a/202509083507721654.html
- Source: drugdu
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- September 10, 2025
Samsung Biopharma signs $1.29 billion contract with US pharmaceutical company

Samsung Biologics announced on September 9th that it had signed a contract manufacturing organization (CMO) contract worth US$1.29464 billion (approximately 1.8001 trillion won) with a US pharmaceutical company. This contract, the second-largest order in the company’s history, runs until December 31, 2029. The client and product names are not being disclosed due to confidentiality clauses. Source：https://finance.eastmoney.com/a/202509093508399792.html
- Source: drugdu
- 104
- September 10, 2025
Beike Biopharma initiates Phase I clinical trial of HSV-2 mRNA vaccine

According to People’s Finance News on September 9, ” Bai Ke BioAccording to a WeChat official account, on September 9th, Beike Bio successfully held a kickoff meeting for the “Phase I Dose-Escalation Trial of the Safety, Tolerability, and Immunogenicity of an HSV-2 mRNA Vaccine in Subjects Aged 18 to 55 with Different Serological Infections” at Beijing Jishuitan Hospital. The kickoff meeting provided systematic training and work deployment on core topics such as genital herpes disease and vaccine development background, GCP standards, clinical trial protocols, investigator brochures, sample management, and on-site procedures. Subsequently, all work preparations were in place, and subject enrollment was about to begin in full swing. Source：https://finance.eastmoney.com/a/202509093508939621.html
- Source: drugdu
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- September 10, 2025
【EXPERT Q&A】Under the EU MDR regulation, what key requirements should be met to prove the equivalence of medical devices?

Drugdu.com expert’s response: Under the framework of the EU MDR (Medical Device Regulation), proving the equivalence of medical devices requires constructing an argumentation system from three major dimensions: technical characteristics, biological characteristics, and clinical characteristics, to ensure that there are no significant differences in safety, performance, and clinical effectiveness between the declared device and the already-marketed device. Here are the specific requirements and analyses: I. Technical Characteristics: Ensuring Consistency in Functional Principles and Usage Conditions Similarity in Usage Conditions The declared device and the already-marketed device must be used under similar conditions, meaning there are no significant clinical differences in safety and clinical performance. For example, blood glucose meters should maintain consistent measurement accuracy and stability in different medical institutions (such as tertiary hospitals and community clinics) or when used by different patient groups (such as elderly and young diabetic patients). Regulatory Basis: The MDR requires compliance with the MEDDEV ...
- Source: drugdu
- 197
- September 10, 2025
Biodegradable scaffold with magnesium and glutamine accelerates bone regrowth

For most broken bones, bone cells regrow on their own while patients wear a cast or brace to keep the injury steady. But for complex or severe fractures, surgeons may intervene by placing grafts or scaffolds made of biocompatible materials, or by using metal fixation devices to ensure proper bone healing and alignment. Collaborating with orthopedic surgeons, a team led by biomedical engineering researchers at Penn State created CitraBoneQMg, an implantable biodegradable scaffold to support bone regrowth made by combining magnesium and glutamine with citric acid. They published research on their implant, for which they filed a U.S. patent application, in Science Advances. “By integrating magnesium and glutamine – two small molecules found naturally in the body and in food – with citric acid, we found that the molecules work together to promote bone growth by encouraging increased intracellular energy metabolism,” said first author Hui Xu, a doctoral student in ...
- Source: drugdu
- 100
- September 9, 2025
Another New Hampshire Man Gets a Pig Kidney as Transplant Trials Are Poised to Start

A self-described science nerd is the latest American to get an experimental pig kidney transplantWASHINGTON (AP) — A self-described science nerd is the latest American to get an experimental pig kidney transplant, at a crucial point in the quest to prove if animals organs really might save human lives. The 54-year-old New Hampshire man is faring well after his June 14 operation, doctors at Massachusetts General Hospital announced Monday. “I really wanted to contribute to the science of it,” Bill Stewart, an athletic trainer from Dover, New Hampshire, told The Associated Press. That’s not the only milestone the Mass General team is marking: A pig kidney has kept another New Hampshire man, Tim Andrews, off dialysis for a record seven months and counting. Until now, the longest that a gene-edited pig organ transplant was known to last was 130 days. Based on lessons from the New Hampshire men and a ...
- Source: drugdu
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- September 9, 2025
Bowang Pharmaceuticals and Novartis deepen strategic collaboration to accelerate the development of new drugs for cardiovascular diseases

Under the agreement, the two companies will jointly explore ANGPTL3 combination therapies for the treatment of dyslipidemia. The agreement also includes Novartis’s option to license next-generation molecules in Bowang Pharmaceutical’s pipeline. Novartis acquires rights to an siRNA candidate from BoWang Pharmaceuticals currently in IND-enabling studies BoWang Pharmaceuticals will receive an upfront payment of $160 million, options for profit-sharing in multiple territories, potential near-term equity investments, and is eligible for option payments, clinical development and sales milestone payments, and tiered royalties on commercial sales. Shanghai, China and Boston, USA, September 3, 2025 – Bowang Pharmaceuticals, Inc. (“Bowang Pharmaceuticals” or the “Company”) today announced a new strategic collaboration agreement with Novartis (NYSE: NVS) to jointly develop multiple cardiovascular products. This new agreement expands upon the existing collaboration between the two companies. Dr. Shu Dongxu, Co-founder, Chairman and CEO of BoWang Pharmaceuticals, said: “We are very pleased to deepen our collaboration with Novartis, ...
- Source: drugdu
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- September 9, 2025
The State Food and Drug Administration issued special regulations on the supervision and management of traditional Chinese medicine production

People’s Finance News reported on September 8 that the State Food and Drug Administration officially released theSpecific regulations on production supervision and management set new requirements for the production oversight of traditional Chinese medicines , including Chinese herbal medicine slices, Chinese herbal formula granules, Chinese patent medicines, Chinese herbal medicines subject to approval management, and Chinese herbal medicine extracts subject to filing management. These regulations focus on the quality of Chinese herbal medicines at the source and key aspects of production, propose targeted solutions, and encourage companies to upgrade their production and promote digital transformation. These regulations will officially take effect on March 1, 2026. https://finance.eastmoney.com/a/202509083507488070.html
- Source: drugdu
- 211
- September 9, 2025
Huisheng Biopharma’s self-developed GLP-1R/GCGR dual-target innovative drug P052 injection receives IND approval

According to AI Express of the National Business Daily, on September 9, Sihuan Pharmaceutical announced that its non-wholly owned subsidiary Huisheng Biopharma independently developed an innovative dual-target agonist drug for the glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR).The new drug clinical trial application (IND) for P052 injection has been granted implicit approval by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of type 2 diabetes, overweight or obesity. https://finance.eastmoney.com/a/202509093508167161.html
- Source: drugdu
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- September 9, 2025
Henlius HLX17 receives U.S. FDA approval for clinical trials

Fosun Pharma announced on the evening of September 8th that its controlling subsidiary, Shanghai Henlius Biotech Co., Ltd., and its subsidiaries (collectively, “ Henlius “), have recently received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I clinical trial of HLX17 (a recombinant anti-PD-1 humanized monoclonal antibody injection) for the treatment of patients with various resected solid tumors. Henlius intends to conduct this international, multicenter clinical study in the United States once conditions permit. https://finance.eastmoney.com/a/202509083507723471.html
- Source: drugdu
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- September 9, 2025

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