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CPhI South East Asia

Organiser：Informa Markets Time：July 8–10, 2026 Address：Queen Sirikit National Convention Center, 60 Ratchadaphisek Rd, Khlong Toei, Bangkok 10110, Thailand Exhibition hall：Queen Sirikit National Convention Center Product range: APIs (Active Pharmaceutical Ingredients): Vitamins, hormones, sulfonamides, antipyretics & analgesics, tetracyclines, amino acids & derivatives, chloramphenicols, digestive system drugs, other anti-infectives, penicillins, aminoglycosides, lincosamides, cardiovascular drugs, antiparasitics, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western chemical APIs Packaging & Machinery: Pharmaceutical machinery, packaging machinery, packaging materials, drug production equipment & technology, drug packaging equipment, drug packaging materials, drug production, cleaning & disinfection systems, and laboratory instrument systems Pharmaceutical Products: Various proprietary Chinese medicines, Western medicines, new drugs, various APIs, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, Chinese herbal medicines, herbal extracts, animal & plant extracts, veterinary drugs, food ingredients & additives, etc. About CPhI South East Asia： CPhI South East Asia is the most authoritative pharmaceutical ingredients exhibition in ...
- Source: drugdu
- 27
- June 11, 2026
A world first! Coagulation Factor X activator – Bomitai enzyme α for injection (Bojia Ning) – conditionally approved for marketing!

On June 9, 2026, Jiangsu Beijietai Biotechnology Co., Ltd., a wholly-owned subsidiary of Shutaishan, received the Drug Registration Certificate for Bomitai Enzyme Alpha for Injection (trade name: Bojia Ning) issued by the National Medical Products Administration. This drug is a Class 1 therapeutic biological product manufactured domestically, with the approval number S20260040. This approval is conditional, and its indication is for the treatment of bleeding in adult patients with congenital hemophilia A or B whose factor VIII or IX inhibitors are >5 Bethesda units (BU). Hemophilia is an X-linked recessive inherited bleeding disorder, characterized by male onset and female carrier status. Hemophilia can be divided into hemophilia A and hemophilia B. Hemophilia A is characterized by a deficiency of clotting factor VIII (FVIII), while hemophilia B is characterized by a deficiency of clotting factor IX (FIX), both caused by mutations in the corresponding clotting factor genes. The clinical feature of ...
- Source: drugdu
- 48
- June 10, 2026
It’s here! Xanomeprazole Chloride Capsules (Kagero®) are now available, benefiting schizophrenia patients in China

On June 9th, Zai Lab’s first neurological product, Xanomelide Traxodium Chloride Capsules (Kagero® ) , was shipped from Suzhou and began supplying hospitals and pharmacies in multiple provinces and cities across China. On the same day, the drug was prescribed for the first time nationwide at Beijing Anding Hospital affiliated with Capital Medical University, and subsequently reached schizophrenia patients in over 30 cities and nearly 50 hospitals across the country. Ni Qian, member of the Party Working Committee and deputy director of the Management Committee of Suzhou Industrial Park, said: Zai Lab is a key witness to and participant in the booming development of the biopharmaceutical industry in the park. Ten of its innovative products, including Xanomeprazole and Traxolium chloride capsules , have been approved for marketing in China, demonstrating strong resilience and innovation capabilities. We will continue to support companies like Zai Lab, encouraging them to deepen their presence ...
- Source: drugdu
- 45
- June 10, 2026
World’s First! Tianguangshi’s High-Efficacy Drug Approved for Market Launch

On June 9, the NMPA website showed that Tianguangshi MIL62 (generic name: Oxtuzumab β injection ) has been approved for a new indication: the treatment of primary membranous nephropathy (PMN) , becoming the world’s first drug approved for this indication. MIL62 is an innovative third-generation CD20 antibody drug independently developed by Tianguangshi . It was approved for marketing in China in February 2026 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) . It is the world’s first CD20 antibody for the treatment of this disease and also the first domestically produced drug in China in this field. On June 4, 2026, Tianguangshi and Everest Medicines reached a commercialization licensing agreement for the drug and signed a relevant agreement, authorizing the clinical development and commercialization rights of MIL62 in the Asia-Pacific region (Southeast Asia, India, South Korea, Australia, New Zealand, Hong Kong, Macau and Taiwan) . According to the relevant ...
- Source: drugdu
- 42
- June 10, 2026
Another powerful tool has been added to Qilu Pharmaceutical’s arsenal, with another blockbuster drug receiving market approval

Parkinson’s disease is a common neurodegenerative disease that causes great inconvenience to patients’ lives. Especially in the middle and late stages, patients often face severe deterioration of motor function, such as recurrent episodes of muscle stiffness, tremors, and difficulty moving, which greatly reduces their quality of life. On June 9, 2026 , according to the latest information on the official website of the National Medical Products Administration ( NMPA ) of China, salfedipine mesylate tablets , submitted by Qilu Pharmaceutical Co., Ltd. under Category 4 of chemical drug registration , were approved for marketing and are considered to have passed the evaluation. It is mainly used to treat idiopathic Parkinson’s disease in patients who experience motor fluctuations after receiving stable doses of levodopa. Safinamide mesylate tablets are a selective inhibitor of monoamine oxidase type B (MAO-B) with a unique mechanism of action that reduces dopamine degradation and regulates glutamate release, ...
- Source: drugdu
- 37
- June 10, 2026
Huadong Medicine’s application for a change of indication for its Yiyanshi® S-type forehead filler has been accepted, potentially marking another step forward in its high-end regenerative filler business.

On June 9, Huadong Medicine (000963.SZ) announced that its application for a new indication for Ellansé® S – type , an imported Class III medical device injectable polycaprolactone microsphere facial filler , for subcutaneous or suprapeophyte implantation in the forehead to improve moderate to severe forehead contour defects, has been formally accepted by the National Medical Products Administration (NMPA). This application is expected to expand its scope from nasolabial folds to the forehead contour area, strengthening the company’s multi-indication competitive advantage in the PCL regeneration field and enriching its supply of refined facial anti-aging solutions, further releasing the product’s clinical value. Ellansé® is one of the core products of Huadong Medicine Aesthetics , and is known as the ” Youthful Needle” due to its outstanding triple effect of “immediate filling + long-lasting maintenance + natural metabolism”. As the first approved imported PCL high-end facial filler in China, the application for ...
- Source: drugdu
- 43
- June 10, 2026
Inpacpen DCP®, a pen injector made in China, has obtained FDA approval in the United States, ushering in a new era for drug-device combination products going global!

Recently , a strategic partner of Shanghai Newyao Baike Medical Technology Co., Ltd. (Shanghai Newyao Baike Medical Technology Co., Ltd.) received formal approval from the U.S. Food and Drug Administration (FDA) for its Inpacpen DCP® disposable adjustable-dose cartridge injection pen, successfully approved for use in its liraglutide injection! This is the first drug-device combination product approved by the FDA using a pen syringe manufactured in China, marking a historic step for China’s high-end drug delivery devices in entering the international market with the highest regulatory standards. It is also the company’s third product to receive approval in the U.S. market, following the Safetis® needle protector and the InpacJector® Luer pre-filled syringe (COP)!A historic breakthrough in China’s drug-medicine combination products Liraglutide, a blockbuster GLP-1 drug, has long relied on European and American suppliers for its delivery devices. This approval signifies that Chinese-made pen injectors have officially entered the world’s most stringent ...
- Source: drugdu
- 37
- June 10, 2026
【EXPERT Q&A】How long does it take to obtain a medical device registration certificate for exporting Chinese medical devices to Malaysia?

Drugdu.com expert’s response: The time required to obtain an MDA medical device registration certificate for exporting Chinese medical devices to Malaysia mainly depends on the product risk class and whether an expedited pathway is used. Standard Processing Time (No Expedited Pathway) Under Malaysia’s Medical Device Act 2012, products are classified into four risk categories: Class A (Low Risk): e.g., gauze bandages, medical rubber plaster, cooling oil → 6–9 months Class B (Moderate-Low Risk): e.g., povidone-iodine solution, disposable sterile obstetric surgical pack → 9–12 months Class C (Moderate-High Risk): 12–18 months Class D (High Risk): 18–24 months Expedited Pathway: As Fast As 30 Working Days This is currently the most notable channel. Malaysia and China have launched a regulatory cooperation program. Products holding a China NMPA registration certificate can apply through the MDA Verification Pathway via a CAB (Conformity Assessment Body) assessment, shortening the approval time to approximately 30 working days. Eligibility: hold NMPA / CE / FDA / TGA registration from ...
- Source: drugdu
- 39
- June 10, 2026
QMEE QINGDAO

Organiser：Asia Economic & Trade Development Promotion Center, China Council for the Promotion of International Trade Shandong Provincial Committee, Qingdao Medical Association Time：July 2–4, 2026 Address：Qingdao International Convention and Exhibition Center, No. 9 Miaoling Road, Laoshan District, Qingdao Exhibition hall：Qingdao International Convention and Exhibition Center Product range: Diagnostic & Treatment Equipment: X-ray imaging, ultrasound diagnostics, endoscopy systems, monitoring equipment, scanning devices, optical instruments, and examination/diagnostic equipment for neurology, orthopedics, ENT, ophthalmology, pathology, etc. Laboratory: Testing instruments, laboratory equipment, biochemical analysis & diagnostic reagents, sterilization & disinfection equipment, cleanroom engineering, gas supply systems, cryogenic & freezing equipment, etc. Rehabilitation & Nursing: Various therapeutic devices, rehabilitation training equipment, nursing instruments, special mobility aids, barrier-free facility series, healthcare equipment, assistive devices. Digital Healthcare: Intelligent examination & checkup devices, Medical Image Archiving & Communication System (PACS), Hospital Information System (HIS), digital community healthcare systems, telemedicine systems, healthcare information solutions, medical software development, electronic medical ...
- Source: drugdu
- 46
- June 9, 2026
Jingfang Pharmaceuticals’ small molecule drug receives Fast Track designation from the US FDA for lung cancer

On June 5th, GenFang Pharmaceuticals announced that GFH375/VS-7375 ( an oral KRAS G12D inhibitor ) received Fast Track Designation (FTD) from the U.S. FDA for the treatment of previously treated patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with KRAS G12D mutations (concurrent or sequentially treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors) . Previously, GFH375/VS-7375 received another Fast Track Designation from the FDA last year for the treatment of first-line and later-line KRAS G12D -mutant metastatic pancreatic ductal adenocarcinoma (PDAC). Furthermore, GFH375 has already received two Breakthrough Therapy Designations (BTD) in China this year for monotherapy in KRAS G12D -mutant advanced pancreatic cancer and NSCLC. GFH375 is an orally administered, highly active, and selective small-molecule KRAS G12D (ON/OFF) inhibitor. It binds to the KRAS G12D protein non-covalently, inhibiting its binding to downstream effector proteins, thereby disrupting the sustained activation of downstream pathways by KRAS G12D in ...
- Source: drugdu
- 61
- June 8, 2026

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