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World’s first! CSPC Group’s paclitaxel for injection (albumin-bound) (II) approved for marketing

On June 15, CSPC Group’s paclitaxel for injection (albumin-bound) (II) (R&D code: SYHX2011) was approved for marketing by the National Medical Products Administration. This product is the world’s first fast-dissolving albumin-bound paclitaxel formulation, backed by independently developed innovative formulation and manufacturing processes, and has obtained patent authorizations in multiple countries including China, the U.S., and Europe. As a Class 2.2 modified new chemical drug, it represents a comprehensive upgrade in efficacy, safety, and clinical convenience, filling many of the clinical gaps of conventional albumin-bound paclitaxel, marking CSPC Group’s technological breakthrough in the field of antitumor nanomedicines and offering a better chemotherapy option for patients with advanced breast cancer. Figure 1. CSPC paclitaxel for injection (albumin-bound) (II) approved for marketing, source: NMPA website 01Breast Cancer and Taxanes Breast cancer is a highly prevalent malignant tumor in China. According to a report by the National Cancer Center of China, there were ...
- Source: drugdu
- 90
- June 17, 2026
Valuation of 7 billion yuan! Another large financing deal lands in the vaccine sector

On the evening of June 15, Fosun Pharma (600196) issued an official announcement that its vaccine platform, Fosun A&T, had completed a new round of capital increase and share expansion, issuing an additional 11.4954 million shares to four investors at a price of RMB 84.21 per share, raising a total of RMB 968 million and implying a pre-investment valuation of RMB 7 billion. This is a key capital move in Fosun A&T’s preparation for a Hong Kong IPO, and it has also injected important momentum into the R&D and commercialization of its vaccine pipeline.I. A star-studded investor lineup: Fosun leads the round, with China Resources and Chengdu state-owned capital joining in The investor mix in this capital increase is highly representative of the industry, underscoring the capital market’s long-term confidence in the vaccine sector: • Fosun Pharma Industry (controlling shareholder): Invested RMB 550 million to subscribe for 6.5315 million shares, ...
- Source: drugdu
- 75
- June 17, 2026
【EXPERT Q&A】What problems do pharmaceutical companies have in the quality management of drug production?

Drugdu.com expert’s response: Common issues in pharmaceutical production quality management are generally concentrated in the following areas: Personnel & Awareness Quality management in many companies remains at the level of “passing inspections” rather than being truly internalized into production habits. Frontline operators have high turnover, training is superficial, and SOP non-compliance is widespread. The quality department lacks authority and often yields to production when output and quality conflict. Data Integrity This is a key regulatory enforcement focus in recent years. Handwritten records are casually altered, electronic data lacks audit trails, abnormal data is deleted without trace, and shared login accounts are common — especially prevalent among small and mid-sized pharma companies. FDA and NMPA requirements on data integrity are tightening, yet many companies’ IT systems are still stuck at the Excel stage. Deviation & Change Control Out of Control When deviations occur, the first instinct is to find a workaround, ...
- Source: drugdu
- 63
- June 17, 2026
Pharma Pro & Pack Expo

Organiser： IPMMA (Indian Pharmaceutical Machinery Manufacturers’ Association), GPE Exhibitions Time：July 9–11, 2026 Address：HITEX Exhibition Centre, Izzat Nagar, Hyderabad 500 032, A.P. Exhibition hall：Hyderabad International Trade Exposition Centre (HITEX) Product range: Machinery & Equipment: Pharmaceutical processing and packaging, laboratory equipment Materials: Packaging materials and consumables, glassware, laboratory ware and consumables Chemicals & Pharmaceuticals: Active Pharmaceutical Ingredients (APIs), excipients, laboratory reagents and chemicals, bulk formulations, active pharmaceutical substances Project Management: Utilities, consulting, turnkey services, eco-friendly products and services Trade Promotion: Trade associations, institutions, publications Others: Pharmaceutical production services, contract manufacturing, CRO/CDMO service providers, research institutions, testing laboratories and related services About Pharma Pro & Pack Expo： Pharma Pro & Pack Expo is the largest, most leading, and most influential pharmaceutical packaging exhibition in South Asia. Co-organized by the Indian IPMMA Association and GPE Exhibitions, the event has received strong support from official media and India’s healthcare industry. Since the establishment of ...
- Source: drugdu
- 63
- June 16, 2026
【EXPERT Q&A】How do the approval and supervision processes of medical devices ensure their safety?

Drugdu.com expert’s response: The core logic is: risk-based classification → strict pre-market review → continuous post-market surveillance, forming a full lifecycle closed loop. I. Classification: Risk Determines Regulatory Intensity Under the Regulation on the Supervision and Administration of Medical Devices, devices are divided into three classes: Class I (Low Risk): Filing system, formal review only. Examples: medical cotton swabs, surgical gowns. Class II (Moderate Risk): Registration system, reviewed and approved by provincial drug administration. Examples: blood pressure monitors, CT scanners. Class III (High Risk): Registration system, reviewed and approved by the National Medical Products Administration (NMPA). Examples: cardiac stents, artificial joints. Higher risk means stricter review — classification itself is the first safety filter. II. Pre-Market Approval: Four Core Gates Taking Class II and III as examples: Gate 1: Product Technical Requirements & Testing Must complete biological evaluation, electrical safety, performance testing, etc., to prove the product itself is qualified. Class III ...
- Source: drugdu
- 75
- June 15, 2026
【EXPERT Q&A】Do Class II medical device operations require a “license”?

Drugdu.com expert’s response: No. You don’t need a “license” for Class II medical devices — you only need to file a record . To be precise, the term “Class II Medical Device Operation License” itself is incorrect. According to Article 30 of the Medical Device Supervision and Administration Regulations: Class I: No license required, no filing required Class II: No license required, but filing is mandatory. You obtain a Class II Medical Device Operation Filing Certificate Class III: License required. You apply for a Medical Device Operation License So the correct procedure for Class II is: submit filing materials to the municipal-level drug administration department where the enterprise is located. If materials are complete and meet requirements, the certificate is issued on the spot. The filing certificate has no fixed expiry date. When enterprise information changes, a change filing must be processed. When operations cease, the filing must be actively cancelled.
- Source: drugdu
- 83
- June 12, 2026
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
- 79
- 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
- 110
- 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
- 97
- 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
- 119
- June 10, 2026

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