media – Page 34 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Tetasip, the first application!

On October 15, Rongchang Biopharma announced that its independently developed, first-in-class BLyS/APRIL dual-target fusion protein drug, Tetasip, for the treatment of primary immunoglobulin A (IgA) nephropathy has been accepted for marketing approval by the China Drug Administration (CDE) and has been placed under priority review. This marks Tetasip as the first domestically developed, research-driven new drug to be approved for marketing in the field of IgA nephropathy, bringing new hope to patients. Tetasip is the world’s first innovative dual-target fusion protein drug that simultaneously targets B-cell activating factor (BLyS) and proliferation-inducing ligand (APRIL). These two cytokines are significantly elevated in patients with IgA nephropathy, driving abnormal B cell activation, antibody class switching, and the production of pathogenic IgA. Ultimately, this leads to the deposition of immune complexes in the glomeruli, triggering inflammation and tissue damage. By simultaneously inhibiting BLyS and APRIL, Tetasip is able to reduce the number of mature ...
- Source: drugdu
- 121
- October 27, 2025
ADB116 for injection receives approval for clinical trial

October 24, Aidi Pharmaceuticals(688488.SH) announced that the company and its controlling subsidiary, Nanjing Nanda Pharmaceutical Co., Ltd., have received the “Notice of Approval for Clinical Trial of a Drug” from the National Medical Products Administration (NMPA), authorizing the company to conduct clinical trials of its investigational Class 2 chemically modified new drug, ADB116 for injection. This drug is intended for thrombolytic therapy in patients with acute ischemic stroke. If successfully approved for marketing in the future, it will provide more treatment options for stroke patients and further enhance the company’s core competitiveness and development potential. However, it should be noted that after receiving the Notice of Approval for Clinical Trial of a Drug, the drug must undergo clinical trials to obtain efficacy and safety data, and must undergo review and approval by the NMPA before it can be manufactured and marketed. Source：https://finance.eastmoney.com/a/202510243543623696.html
- Source: drugdu
- 126
- October 27, 2025
Selling subsidiary equity to Hillhouse Capital to fully focus on CRDMO

On October 26, WuXi AppTec (603259/02359) issued an announcement that its wholly-owned subsidiary Shanghai WuXi AppTec New Drug Development Co., Ltd. intends to transfer its 100% equity in Shanghai Kangde Hongyi Medical Clinical Research Co., Ltd. and Shanghai WuXi Jinshi Pharmaceutical Technology Co., Ltd. to Shanghai Shiherong Enterprise Management Consulting Co., Ltd. and Shanghai Shihemu Enterprise Management Consulting Co., Ltd. for a consideration of RMB 2.8 billion. To focus on the CRDMO (Contract Research, Development and Manufacturing) business model, focusing on drug discovery, laboratory testing, process development and manufacturing services, and accelerating the deployment of global capabilities and production capacity, the company’s wholly-owned subsidiary Shanghai WuXi intends to transfer 100% of its equity in Kangde Hongyi and Jinshi Pharmaceutical.To the transferees. The transferees are all newly established companies by Hillhouse Capital through its private equity funds for the purpose of this transaction. In the first three quarters of 2025, WuXi AppTec achieved revenue of 32.857 billion yuan ...
- Source: drugdu
- 199
- October 27, 2025
First patient enrolled in Phase IIa clinical trial of ophthalmology drug for delaying myopia in children in China

On October 26, Yuanda Pharmaceutical announced that the first patient has been enrolled in a Phase IIa clinical study in China of its innovative ophthalmic drug, GPN00884, for slowing the progression of myopia in children. This marks the beginning of a crucial phase of dosing and preliminary efficacy assessment for GPN00884. This Phase IIa trial is a randomized, double-blind, placebo-controlled study enrolling over 80 myopic subjects aged 6 to 12 years. The study aims to preliminarily evaluate the efficacy and safety of GPN00884 eye drops in slowing the progression of myopia in children. Source：https://finance.eastmoney.com/a/202510263544490960.html
- Source: drugdu
- 156
- October 27, 2025
Novartis to acquire Avidity Biosciences for approximately $12 billion

Novartis agreed to acquire Avidity Biosciences for approximately $12 billion, or $72 per share. The acquisition will help Novartis expand its rare disease treatment pipeline, particularly for muscle diseases. Avidity Biosciences will spin out its early-stage heart disease treatment program into a new company called Spinco, which is expected to go public. Avidity Biosciences, whose flagship drug Del-zota is in early-to-mid-stage clinical trials for Duchenne muscular dystrophy, also has other drug candidates for severe muscle diseases. The acquisition fits with Novartis’ recent strategy of addressing patent cliffs on some of its blockbuster drugs through a series of deals. Source：https://finance.eastmoney.com/a/202510273544630680.html
- Source: drugdu
- 94
- October 27, 2025
【EXPERT Q&A】What is the Unique Device Identifier (UDI) for medical devices?

Drugdu.com expert’s response: The Unique Device Identifier (UDI) is a core tool in the international regulatory landscape for medical devices, designed to enable precise traceability and management throughout the entire lifecycle of medical devices via standardized coding. Its core components, implementation logic, and value are outlined below: I. UDI Composition: Dual-Code Synergy for Precise Identification The UDI consists of two parts—the Device Identifier (DI) and the Production Identifier (PI)—forming a “static + dynamic” dual-recognition system: Device Identifier (DI): Serves as the foundational identity code for medical devices, encompassing registrant/filing entity information, model specifications, and packaging hierarchy. For example, the DI of a specific brand of cardiac stent uniquely identifies its manufacturer, product model, and packaging format (e.g., single unit or boxed). The DI remains stable once assigned, ensuring traceability of basic product information. Production Identifier (PI): Acts as the dynamic information code for medical devices, covering production batch numbers, serial numbers, manufacturing ...
- Source: drugdu
- 167
- October 27, 2025
TSL2109 capsules approved for clinical trials

recently announced that its wholly-owned subsidiary, Jiangsu Tasly Diyi Pharmaceutical Co., Ltd., received the “Notice of Approval for Clinical Trial of Drugs” from the National Medical Products Administration (NMPA) for TSL2109 Capsules for the treatment of advanced solid tumors. TSL2109 Capsules, jointly developed by Jiangsu Diyi and China Pharmaceutical University, is a novel dual-target small molecule inhibitor. It selectively inhibits the downstream signaling pathways of both targets, arrests the tumor cell cycle, and induces apoptosis, achieving a synergistic killing effect. Currently, no similar dual-target drugs have entered clinical trials outside of China . As a traditional pharmaceutical company specializing in traditional Chinese medicine and chemical drugs, Tasly has been actively transforming its focus into innovative drugs in recent years. TSL2109 Capsule is a dual-target small molecule inhibitor with a novel structure, a first of its kind globally. However, investors should be aware of the high risks of drug development. Source: https://wap.eastmoney.com/a/202509243522600041.html
- Source: drugdu
- 221
- October 26, 2025
Salubris’s clinical trial application for SAL0137 has been accepted

On the evening of October 15, Xinlitai(002294) issued an announcement stating that the company received an acceptance notice approved and issued by the National Medical Products Administration, and the clinical trial application of the company’s independently developed innovative small molecule drug SAL0137 tablets (project code: SAL0137) was accepted. Xinlitai said that SAL0137 is a product developed by the company with independent intellectual property rights.The company’s application for SAL0137, an oral small molecule drug, is for clinical trials for the treatment of elevated lipoprotein (a). https://finance.eastmoney.com/a/202510153535045923.html
- Source: drugdu
- 173
- October 26, 2025
【EXPERT Q&A】Is it mandatory to have a stability test protocol and report for stress testing during the pharmaceutical R&D process?

Drugdu.com expert’s response Yes, stability test protocols and reports are mandatory for stress testing in the pharmaceutical R&D process. The reasons are as follows: I. Regulatory Requirements Consistency in International and Domestic Regulations: Whether it is China’s NMPA, the U.S. FDA, or the international ICH guidelines, all explicitly mandate that stress testing must be conducted for active pharmaceutical ingredients (APIs), accompanied by comprehensive stability test protocols and reports. These documents are essential prerequisites for drug marketing authorization, and their absence will directly result in application rejection. Essential Materials for Marketing Authorization: Stability test protocols and reports constitute core documentation for drug registration submissions. Regulatory authorities review these files to assess the quality controllability and safety of pharmaceutical products. II. Logical Imperatives in R&D Guiding Subsequent R&D Stages: Stability test protocols meticulously document critical information such as test methods, conditions, and sampling points, providing a foundation for subsequent accelerated and long-term ...
- Source: drugdu
- 154
- October 24, 2025
Simem 2026

Organiser：Algerian Ministry of Health, Algerian Healthcare Reform and Development Commission Time：April 8th -11th, 2025 Address：Les Genets, Chemin de Wilaya, Route 75, Oran, Algeria Exhibition hall：Centre des Conventions d’Oran Product range: Medical Equipment: Medical technology equipment, laboratory instruments and equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, emergency response equipment, hospital, dental, and medical facilities, dental service equipment, disposable medical products for hospitals and households, hospital and dental medical data processing systems, orthodontic and reconstructive equipment. Pharmaceuticals: Foreign prescription drugs, herbal preparations, nutritional health supplements such as minerals and vitamins, dietary nutrition products, homeopathic preparations, dermatological preparations, maternal and child healthcare products and infant food, personal hygiene products, incontinence products, medical consumables, etc. About Simem 2026： The Algerian International Medical Equipment Exhibition (SIMEM) is the most renowned medical equipment exhibition in Algeria. It is the only specialized exhibition for medical devices, pharmaceuticals, and dentistry in ...
- Source: drugdu
- 258
- October 23, 2025

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