On January 5, Insilicon announced a multi-year collaboration with Servier to develop anti-tumor drugs. Under the agreement, InSilicon Technologies combines its AI-driven drug discovery platform with Servier’s expertise in anti-tumor drug development, focusing on the research and development of such drugs. Servier will pay a $32 million upfront payment and recent research milestones, bringing the total agreement value to $888 million. Servier will share the research and development costs and, after nominating a drug candidate, will lead subsequent clinical development, regulatory communications, and commercialization. Founded in 2014, Insil Intelligence is an AI-driven biopharmaceutical company that has built a rich pipeline of innovative research and development over the past 11 years. Its first pipeline, a TNIK inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF), has been included in the Breakthrough Therapy Programme. Subsequent pipeline projects include a USP1 inhibitor, a KAT6 inhibitor, and a TEAD inhibitor. In conclusion , on ...
CNSTOCK News (Shanghai Securities News) — On the evening of January 6, Jointown Pharmaceutical Group (600998.SH) announced that Huiyu Yuanhe (Hainan) Pharmaceutical Co., Ltd., a subsidiary of the company’s unit Beijing Jingfeng Pharmaceutical Group, has received the “Drug Registration Certificate” for Bupivacaine Hydrochloride Injection approved and issued by the National Medical Products Administration (NMPA). According to the announcement, Bupivacaine Hydrochloride Injection is a long-acting amide local anesthetic primarily used for local infiltration anesthesia, peripheral nerve blocks, and spinal blocks. The drug is listed in the National Medical Insurance Category A and the National Essential Medicine List. Data from Minenet shows that in 2024, the sales of Bupivacaine Hydrochloride Injection across China’s three major terminals and six major markets exceeded 200 million RMB. As of the date of the announcement, Huiyu Yuanhe has invested approximately 4.66 million RMB (unaudited) in research and development for this drug. The announcement stated that the ...
On the 5th local time, Novo Nordisk launched its oral weight-loss pill in the United States, with a price significantly lower than that of similar injectable treatments. The medication is now available at over 70,000 pharmacies across the U.S., as well as through select online telehealth platforms. For cash-paying customers, the monthly cost ranges from $149 to $199 (approximately 1,060 to 1,420 RMB). Patients with insurance coverage could pay as little as $25 per month (around 180 RMB). In contrast, current injectable weight-loss drugs from Novo Nordisk and the U.S.-based Eli Lilly both cost over $1,000 per month (approximately 7,100 RMB). While Eli Lilly’s own oral weight-loss drug is expected to receive approval later this year, Novo Nordisk’s early entry into the market is a strategic move aimed at regaining previously lost market share. https://finance.eastmoney.com/a/202601063610098754.html
Drugdu.com expert’s response: The requirements for the quality management of medical device production cover multiple aspects, aiming to ensure the safety and effectiveness of medical devices. The core is to establish and effectively operate a quality management system to systematically control the entire product lifecycle. The specific requirements are as follows: Establishment and Operation of the Quality Management System Establish a system based on product characteristics: Enterprises should, in accordance with regulatory requirements and in combination with the characteristics of the medical devices they produce, establish a sound quality management system that is compatible with the products and ensure its effective operation. This system covers multiple links such as commissioned research and development, commissioned production, outsourced processing, and commissioned inspection. Quality assurance system and documentation: Enterprises should establish a quality assurance system and possess a complete set of quality management system documents to ensure the effective operation of the quality ...
Melanoma is a highly malignant tumor that can occur in multiple parts of the body, such as the palms and soles, under the nails, or in the nasal cavity and digestive tract mucosa. In its early stages, it is often mistaken for a common mole or ulcer. If not detected in time, it can rapidly metastasize and threaten life. Recently, the anti-PD-1 monoclonal antibody drug toripalimab has been added to the list of first-line treatments for unresectable or metastatic melanoma and has been included in the National Basic Medical Insurance Program .This drug is listed in the National Medical Insurance Drug Catalog (2025), specifically the “Drug Catalog for Maternity and Work Injury Insurance ,” and is the only anti-PD-1 monoclonal antibody drug in the catalog used for melanoma. Professor Luo Zhiguo, Deputy Director of the Department of Medical Oncology at Fudan University Cancer Hospital, pointed out that understanding the characteristics ...
On January 5th, Yifan Pharmaceutical…The company announced that its wholly-owned subsidiary, Yifan Pharmaceutical, has signed exclusive agreements with Shangde Pharmaceutical and Tianjin Shangde respectively. Under these agreements, Shangde Pharmaceutical grants Yifan Pharmaceutical an irrevocable and exclusive right to license its independently developed product, dimethylamino micaceous lactone fumarate monohydrate, within the designated cooperation area. Yifan Pharmaceutical is authorized to use the licensed intellectual property rights within the cooperation area.The company will develop, manufacture, and commercialize the target product, and simultaneously grant exclusive priority negotiation rights for the production and commercialization of the target product for other indications within the cooperation area. In addition, Yifan Pharmaceutical will pay Shangde Pharmaceutical a down payment of RMB 100 million, a cornerstone investment of RMB 100 million or a milestone payment of RMB 50 million (choose one), tiered net sales revenue sharing, and a share of sublicense revenue outside of China (if any). The announcement ...
CanSino Biologics Inc. (hereinafter referred to as “CanSino Biologics”) announced today that its independently developed 24 -valent pneumococcal polysaccharide conjugate vaccine ( CRM197/ tetanus toxoid, hereinafter referred to as “PCV24” ) has received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, agreeing to conduct clinical trials for the product. This marks the continued expansion of CanSino Biologics’ R&D pipeline in the field of pneumococcal conjugate vaccines, laying the foundation for further enriching its portfolio of high-valent pneumococcal vaccine products. Pneumococcal disease is one of the most serious public health problems worldwide . <sup>1</sup> World Health Organization (WHO) data shows that approximately 1.6 million people die globally each year from pneumococcal-related diseases, with infants and the elderly being the most affected groups . <sup>2 </sup> Streptococcus pneumoniae is a major pathogen causing serious diseases such as pneumonia, meningitis, and bacteremia in children, and is also a ...
Recently, the CDE (Center for Drug Evaluation) website announced that the new indication for Vidistovimab injection in combination with trastuzumab and toripalimab as first-line treatment of HER2-high expressing advanced gastric/gastroesophageal junction adenocarcinoma is proposed for inclusion in the Breakthrough Therapy designation. If successfully approved, this will be the fourth Breakthrough Therapy designation received by this drug since its launch in 2021, setting a new record for regulatory approval of domestically produced ADC (anti-adrenergic cellular carcinoma) drugs. HER2 is an important therapeutic target for gastric cancer, accounting for approximately 12%-23% of all gastric cancers. If low-to-medium HER2 expression is included, then about 40%-45% of gastric cancer patients express HER2. These tumors are more aggressive and prone to recurrence and metastasis. Vidicetumab (trade name: Aidixi® ) is China’s first original ADC drug developed by Rongchang Biotechnology. Targeting the HER2 protein on the tumor surface, it can precisely identify and kill tumor cells. ...
BTK inhibitors are transforming from a “darling” of hematological malignancies into a “rising star” in the autoimmune field. This star target, with its central role in B-cell and myeloid cell signaling pathways, has successfully broken down the boundaries of the therapeutic field, “crossing over” from oncology to the autoimmune field . 01 Star Target BTK is a non-receptor tyrosine kinase that plays a central role in signal transduction of various cell surface receptors (mainly BCR). After B cell carcinogenesis, BTK becomes abnormally active. Activation of the BTK signaling pathway sends a signal to initiate the growth of B cell malignant tumor cells and plays an important role in growth and migration. BTK inhibitors (BTKi) act on the BCR signaling pathway, specifically binding to BTK to inhibit BTK autophosphorylation, prevent BTK activation, thereby blocking signal transduction and inducing apoptosis, thus controlling the development of B-cell tumors. Since the first covalent BTKi ...
MSD’s Breakthrough Drug Sotatercept (Winrevair®) Approved in China for Pulmonary Arterial Hypertension Shanghai Securities News (Reporter: Zhang Xue) — On January 5, MSD (known as Merck & Co. in the U.S. and Canada) announced that Winrevair® (Sotatercept for Injection), the world’s first and currently only breakthrough activin signaling inhibitor (ASI) therapy, has been approved by China’s National Medical Products Administration (NMPA). The drug is indicated for the treatment of adults with Pulmonary Arterial Hypertension (PAH, WHO Group 1) who have WHO Functional Class (FC) II-III symptoms, aiming to improve exercise capacity and WHO functional class. PAH is a relatively rare and difficult-to-treat cardiovascular disease. Research suggests that the median survival period for patients with idiopathic PAH who do not receive targeted treatment is only 2.8 years after the onset of symptoms. As the disease progresses, patients face increasing limitations in physical activity; in severe cases, they may become unable to ...
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