Qingfeng Pharmaceutical’s apalutamide tablets have been approved, adding another powerful tool to the field of anti-tumor therapy

According to the official website of the National Medical Products Administration (NMPA), the generic apalutamide tablets submitted by Kerui Pharmaceutical, a subsidiary of Qingfeng Pharmaceutical Group, were approved for production on May 19 and are considered to have passed the consistency evaluation. This is the third endocrine therapy chemical drug approved for Qingfeng Pharmaceutical, marking a new milestone in the company’s R&D and commercialization strategy in the field of prostate cancer treatment. 0 1 Apalutamide tablets: A new generation of androgen receptor inhibitors Blockbuster drugs for prostate cancer treatment Apalutamide is a new generation of oral, highly selective nonsteroidal androgen receptor (AR) inhibitors. It competitively blocks androgen binding by binding to the intracellular ligand-binding domain of AR with high affinity, inhibiting receptor conformational changes and nuclear translocation, and preventing AR translocation into the nucleus.¹ Simultaneously, it blocks the binding of AR to DNA response elements, inhibiting the transcription ...

• Source: drugdu
• 177
• June 25, 2026

PHARMCHINA——tHIS ASEAN

Organiser：Sinopharm Exhibition & APHM Time： July 28–30, 2026 Address：Kuala Lumpur Convention Centre, Kuala Lumpur City Centre, Kuala Lumpur, 50088, Malaysia Exhibition hall：Kuala Lumpur Convention Centre, Kuala Lumpur City Centre   Product range: Pharmaceuticals: Chemical drugs, Chinese patent medicines, ethnic medicines, OTC drugs, biological products Pharma R&D Supply Chain: R&D services, CRO, CMO, CDMO, MAH cooperation, registration consulting Chinese Herbal Medicines / Prepared Slices: Bulk herbal slices, traditional prepared slices, refined-packaging slices, small-packaging slices, direct-oral solid slices, wall-broken slices, food-medicine homology herbs & herbal teas, TCM formula granules, new-type prepared slices, raw Chinese herbs, TCM slice production equipment, TCM slice packaging, etc. TCM Wellness: Moxibustion & moxa products, TCM wellness clinics, foot bath & medicinal bath products, TCM beauty, Chinese medicinal oils/ointments, medicinal cuisine, health wine, etc. TCM Diagnostic & Treatment Equipment: TCM diagnostic equipment, TCM instruments, TCM pharmaceutical equipment, etc. Public Health & Protection: Masks, gloves, protective suits, goggles, disinfection products, ...

• Source: drugdu
• 139
• June 23, 2026

【EXPERT Q&A】What certifications are required for medical devices to enter the Saudi market?

Drugdu.com expert’s response:   The core of entering the Saudi market is mandatory registration and certification with the Saudi Food and Drug Authority (SFDA), along with a series of supporting requirements. The following breaks them down by priority. I. Core Certification That Must Be Completed: SFDA Medical Device Registration This is the only legal entry requirement for all medical devices. Unregistered products cannot clear customs or be sold. Registration Process: Submit registration application through the SFDA online system (MDMA / Saudi Drug Registration System) Submit complete technical documentation; SFDA conducts document review Medium-to-high risk products may be required to provide additional test reports or undergo on-site audits Upon approval, a registration certificate is issued (typically valid for 5 years, renewable upon expiry) II. Products Classified by Risk Level — Requirements Differ SFDA classifies medical devices into four classes. The higher the class, the stricter the review: Class I (Low Risk) — e.g., surgical blades, ...

• Source: drugdu
• 185
• June 22, 2026

Three Conversations We Heard Repeatedly at CPHI China 2026

Three days at CPHI China 2026 gave us the opportunity to meet pharmaceutical manufacturers, suppliers, buyers, and industry professionals from around the world. For Drugdu.com, exhibitions are not only about networking. They are also one of the best places to observe how the pharmaceutical industry is evolving and what companies are focusing on next. After hundreds of conversations across APIs, formulations, extracts, excipients, and pharmaceutical services, a few themes kept coming up. 1. Companies Are Looking for Their Next Growth Market One topic appeared repeatedly throughout the exhibition: Where should we focus next? Latin America. The Middle East. Southeast Asia. These regions were mentioned far more often than we expected. Many companies are no longer asking whether they should expand internationally. They are already active in global markets. The discussion has shifted toward market selection, resource allocation, and identifying the next region that offers sustainable growth. For many pharmaceutical companies, ...

• Source: drugdu
• 192
• June 20, 2026

【EXPERT Q&A】How to apply for a medical device business license?

Drugdu.com expert’s response:   Obtaining a Medical Device Distribution License — the key is to first clarify which class of devices you intend to distribute, as the process for Class II and Class III is completely different. Clarify: Are you applying for a “License” or “Filing”? Class I (Low Risk) — e.g., surgical scalpels, gauze, stethoscopes: Filing during business registration is sufficient. No license required. Class II (Medium Risk) — e.g., blood pressure monitors, thermometers, nebulizers: File with the municipal drug regulatory authority. This is not called a license. Class III (High Risk) — e.g., cardiac stents, CT scanners, ventilators, contact lenses: You must apply for a Medical Device Distribution License from the municipal drug regulatory authority. When people ask about a “license,” they usually mean Class III. The following covers Class III. Application Requirements (Five Mandatory Criteria — All Must Be Met) Personnel: The quality manager must hold a college degree or higher (or intermediate professional ...

• Source: drugdu
• 139
• June 19, 2026

BIO Asia Taiwan — the Asia Biotech Conference & Exhibition

Organiser：Taiwan Bio-Industry Development Association Time：July 15–19, 2026 Address：No. 1, Jingmao 2nd Road, Nangang District, Taipei Exhibition hall：Taipei Nangang Exhibition Center, Trade Center, Taipei   Product range: Pharmaceuticals: New drug development, vaccine preparations (gene therapy, cell therapy), generic drugs, active pharmaceutical ingredients (APIs), Chinese herbal medicine Medical Devices: Medical device R&D, medical electronics, medical imaging, medical instruments, composite medical materials Biotech Services & Testing: Genetic testing, reagents, biochips, cord blood, stem cells, medical services, clinical and pre-clinical trial services (CRO), contract manufacturing (CMO), logistics Equipment & Instruments: Instruments, pharmaceutical equipment (components), packaging, printing, turnkey plant equipment Beauty & Wellness: Medical aesthetic centers, beauty and skincare products, raw materials, packaging containers, beauty instruments, ODM/OEM design services Food & Health: Biotech raw materials, health foods, nutritional supplements, beverage industry, OEM/ODM Agriculture, Fisheries & Aquaculture: Aquaculture, floriculture, bio-fertilizers, bio-pesticides Biotech Funds & Venture Capital: Banking, securities advisory, venture capital, legal, accounting   About BIO ...

• Source: drugdu
• 142
• June 18, 2026

On June 16, foreign media suddenly reported several pieces of news about semaglutide. One was that Novo Nordisk’s oral weight-loss drug Wegovy would soon be launched in China; another was that Novo Nordisk made it clear: regulatory data protection for semaglutide in China will last until the second quarter of 2027, when generics will be able to enter the market. According to foreign media reports, both pieces of news came from Novo Nordisk’s Global President and CEO, Mike Doustdar. In the past few days, Novo Nordisk’s global management has happened to be visiting China. On June 15, Health News reported that Lei Haichao, Director of the National Health Commission, met with several Novo Nordisk executives, to discuss Novo Nordisk’s presence in China and its future strategy. The two major pieces of news above were very likely leaked during this public event, drawing strong market attention. The news about oral semaglutide ...

• Source: drugdu
• 188
• June 17, 2026

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
• 250
• 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
• 170
• 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
• 135
• June 17, 2026