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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
- 198
- 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
- 84
- 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
- 93
- September 9, 2025
EXPOSANITA

Organiser: BolognaFiere S.p.A. (Italian Bologna Exhibition Group) Time：April 22-24, 2026 address：Viale della Fiera, 20, 40128 Bologna BO, Italy Exhibition hall：Bologna Fiere Product range: Hospital Supplies and Technologies: Anesthesia and intensive care, cardiology, transplant devices, clinic engineering, pharmaceuticals, surgical equipment and supplies; automated building systems, temperature control systems, communication systems, medical gases, lighting, security, signage, air conditioning; hospital operating room and lounge furniture, consumables, kitchen equipment, catering equipment, cleaning equipment, sterilization equipment, equipment management, global services. Diagnostic Equipment and Products: Diagnostic equipment, furniture, and apparatus; safety systems for laboratory staff, reagents, consumables; radiology, tomography, magnetic resonance imaging, ultrasound, angiography, endoscopy, products and accessories; cardiology equipment, cerebral X-rays, functional diagnostics, electromyography, product accessories and consumables. Disability, Orthopedics, and Rehabilitation: Equipment, recreational protective gear, training apparatus, transportation aids, personal protective gear; orthopedic technology and equipment, pediatric care, hygiene products, braces, compression stockings, belts, bandages, semi-finished products, paper towels; physical therapy, rehabilitation equipment, ...
- Source: drugdu
- 207
- September 9, 2025
Hengrui once again NewCo

After successfully licensing out its GLP-1 pipeline to the emerging US biotech Hercules using the NewCo model for the first time in May last year, Hengrui Medicine has secured another victory by reaching a new overseas licensing cooperation. 01 NewCo again Today (September 5), Hengrui Medicine reached an exclusive licensing agreement with Braveheart Bio, a US company, to license Braveheart Bio the exclusive rights to develop, produce and commercialize its independently developed cardiac myosin (Myosin) small molecule inhibitor HRS-1893 project globally, excluding mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region and Taiwan. Under the agreement, Braveheart Bio will pay Hengrui Medicine an initial payment of US$65 million (consisting of US$32.5 million in cash and an equivalent of US$32.5 million in Braveheart Bio equity) and US$10 million in near-term milestone payments upon completion of technology transfer, for a total of US$75 million. In addition, Hengrui Medicine ...
- Source: drugdu
- 181
- September 8, 2025
A world first! An innovative drug to delay the progression of type 1 diabetes is approved in China

　　SanofiIt was recently announced that its Tilizumab Injection (trade name: Terico) has been approved by the China National Medical Products Administration (NMPA) for use in children aged 8 years and above and adults with type 1 diabetes stage 2 to delay progression to type 1 diabetes stage 3. 　　Type 1 diabetes is an autoimmune disease caused by the immune system’s destruction of pancreatic beta cells, leading to insufficient insulin secretion or even “starvation.” Patients require lifelong insulin replacement therapy. my country has approximately 600,000 people with type 1 diabetes, ranking third globally. The disease is most common among children and adolescents aged 10-14 years, with a nearly fourfold increase in incidence over the past 20 years. 　　Clinically, type 1 diabetes progresses insidiously, with patients in stages 1 and 2 exhibiting few typical symptoms of diabetes, such as the “three mores and one less” (excessive eating, drinking, and urination, as well ...
- Source: drugdu
- 244
- September 8, 2025
The company’s introduced albumin paclitaxel has been approved for marketing in Oman

　　The company’s related persons told Shanghai SecuritiesAccording to a reporter from the newspaper, the company submitted a registration application for albumin paclitaxel in Oman in January this year, received the registration approval notice only six months later, and recently obtained the official approval document. 　　In recent years, Sinovac BiotechThe company continues to deepen its international presence, focusing on building a high-quality global pharmaceutical export platform with “global product selection and global coverage.” The company has established stable partnerships with numerous renowned domestic and international pharmaceutical companies, while also strengthening its overseas localized operations team, building comprehensive international capabilities encompassing overseas market insights, efficient registration applications, and targeted marketing and promotion. 　　The company’s registration process in the Gulf Cooperation Council (GCC) member states is progressing steadily. Oman was the first to receive approval thanks to its efficient progress. The registration process in markets such as the UAE and Kuwait has also ...
- Source: drugdu
- 153
- September 8, 2025
Breaking the monopoly! Cube Pharmaceuticals launches generic ADHD drug

　　In China, about 20 million children and adolescents are suffering from attention deficit hyperactivity disorder (ADHD), and methylphenidate hydrochloride sustained-release tablets are the first-line treatment for ADHD .A pharmaceutical company has the import drug approval number for this variety, and the corresponding trade name is Zhunzhuda. 　　However, the strict control of dyne and the high price of raw materials have led to frequent supply shortages and even out-of-stock situations, which often cause patients and parents to face medication anxiety .(SZ003020, stock price 32.42 yuan, market capitalization 6.166 billion yuan) announced the official launch of its product, Liyoujia. This is the first generic methylphenidate hydrochloride extended-release tablet in China, breaking the monopoly of Zhongzhuda in the ADHD treatment market. 　　A representative from Lifang Pharmaceuticals told a reporter from the National Business Daily via WeChat on September 5th that after the official launch of Liyoujia, the company will actively apply for reasonable ...
- Source: drugdu
- 144
- September 8, 2025
【EXPERT Q&A】What are the specific principles and mechanisms of action of pancreatic enzymes in digesting cells?

Drugdu.com expert’s response: The core principle of trypsin-mediated cell digestion lies in its proteolytic activity and enzyme-substrate specificity, enabling cell separation by breaking down cell-cell adhesion proteins. The specific mechanisms and actions are as follows: I. Composition and Enzymatic Properties of Trypsin Trypsin is a complex enzyme secreted by the pancreas, primarily containing trypsin, lipase, and amylase. In cell culture, trypsin is the key component responsible for digestion, with the following characteristics: Proteolytic Activity Trypsin, a serine protease, specifically cleaves peptide bonds at the carboxyl terminus of lysine (Lys) or arginine (Arg) residues in protein molecules. This cleavage action breaks down large proteins into smaller fragments, disrupting their three-dimensional structures. Enzyme-Substrate Specificity Trypsin exclusively acts on specific amino acid linkages (e.g., Lys/Arg-X bonds), ensuring that only proteins are digested while other cellular components such as nucleic acids and lipids remain unaffected. This specificity is determined by the active site structure ...
- Source: drugdu
- 211
- September 8, 2025
Akeso Biopharma’s pioneering breakthrough

In the evolution of immuno-oncology, PD-1/PD-L1 inhibitors and anti-VEGF therapies have long represented the two mainstay strategies for immune activation and anti-angiogenesis, respectively. However, with PD-1 monoclonal antibodies like Keytruda (pembrolizumab) firmly dominating the frontline market, subsequent innovation has faced internal competition. Achieving true clinical breakthroughs based on established therapies has become a core concern for the industry. It is against this backdrop that PD-(L)1/VEGF bispecific antibodies have rapidly emerged. By simultaneously blocking both immunosuppressive and angiogenic pathways, they aim to unlock new growth opportunities in the immune checkpoint therapy field, where efficacy curves have been flattening. Over the past two years, innovative Chinese companies have driven a surge in clinical trials and investment in this area. According to statistics, global cumulative transaction volume has exceeded US$25 billion. As the most representative asset, Kangfang Bio’s Ivoximab has been approved for marketing in China, achieving a breakthrough and achieving overall survival ...
- Source: drugdu
- 161
- September 6, 2025

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