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【EXPERT Q&A】What are the common requirements for the registration materials of domestic Class II medical devices?

Drugdu.com expert’s response: A series of documents are required to be submitted for the registration of Class II medical devices in China to ensure the safety, effectiveness, and compliance of the products. The general requirements are as follows: Application Form Fill out and submit the “Application Form for Domestic Medical Device Registration,” which must include a unified approval code. Corporate Qualification Documents A copy of the business license, ensuring that the applied-for product falls within the production or business scope approved by the business license. A copy of the organizational code certificate (if applicable). Medical device manufacturing license (if production is involved). Product Technical Documents Product Technical Requirements: Compiled in accordance with relevant standards, including technical indicators, performance requirements, testing methods, etc. Product Drawings, Structural and Composition Descriptions, and Product Photos: Provide clear visual representations and descriptions of the product. Detailed Technical Documents: Such as product design drawings, production processes, ...
- Source: drugdu
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- March 20, 2026
March 18th National Liver Care Day | Seize the new hope for a cure, don’t let hepatitis B “endure” into liver cancer.

The theme of National Liver Care Day on March 18, 2026, is “Curbing Cirrhosis and Staying Away from Liver Cancer.” For my country, a country with a high prevalence of hepatitis B, this theme is particularly weighty and urgent. The data is alarming: In 2022, my country saw approximately 367,700 new cases of liver cancer and 316,500 deaths, ranking fourth and second among malignant tumors in terms of incidence and mortality, respectively. Even more alarming is that the vast majority of liver cancer patients in my country have a background of hepatitis B virus (HBV) infection, with over 70% of primary liver cancer patients testing positive for hepatitis B surface antigen. Due to late detection, the 5-year overall survival rate for liver cancer patients in my country is less than 15%. However, many hepatitis B patients still have a fatal misconception: ” I have no symptoms and my transaminase levels ...
- Source: drugdu
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- March 19, 2026
A new player enters the race to tap into the $8 billion market! A blockbuster prostate cancer drug welcomes its next challenger.

Recently, the NMPA (National Medical Products Administration) released its latest drug marketing approval announcement, officially approving the marketing of Enzalutamide tablets from Aurite Pharmaceuticals, which is considered to have passed the consistency evaluation. This makes Aurite the third company, following Sichuan Kelun and Qilu Pharmaceutical, to obtain consistency evaluation approval for this product, signifying a further escalation of competition in the market for blockbuster generic prostate cancer drugs. Enzalutamide was originally developed by Astellas and Pfizer, and marketed under the brand name “Xtandi”. As an androgen receptor (AR) inhibitor, enzalutamide plays a crucial role in the treatment of prostate cancer. In August 2012, it was first approved by the US FDA for the treatment of advanced castration-resistant prostate cancer; it officially entered the Chinese market in 2019, becoming an important treatment option for prostate cancer patients in China. From a global market perspective, enzalutamide’s performance has been remarkable. Public data ...
- Source: drugdu
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- March 19, 2026
Shanghai Pharmaceuticals’ cefazolin sodium for injection has passed the generic drug consistency evaluation

On March 18, Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Shangyao Xinya Pharmaceutical Co., Ltd., recently received the “Approval Notice for Supplementary Drug Application” issued by the National Medical Products Administration for its cefazolin sodium for injection, indicating that the drug has passed the consistency evaluation of generic drug quality and efficacy. According to reports, cefazolin sodium for injection is indicated for the treatment of respiratory tract infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, sepsis, infective endocarditis, hepatobiliary system infections, reproductive system infections, and perioperative infection prevention caused by susceptible bacteria. In July 2024, Shanghai Pharmaceuticals New Asia submitted an application to the National Medical Products Administration for consistency evaluation of generic versions of this drug, which was accepted. Shanghai Pharmaceuticals stated that products that pass the consistency evaluation will receive greater support in areas such as medical insurance reimbursement and procurement by medical ...
- Source: drugdu
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- March 19, 2026
HB0025 injection initiates Phase III clinical trial for endometrial cancer

Huahai Pharmaceutical(600521) announced on March 19 that its subsidiary, Shanghai Huaaotai Biotechnology Co., Ltd.Following the completion of the Phase II clinical trial and the pre-initiation meeting for the Phase III clinical trial with the Center for Drug Evaluation of the National Medical Products Administration, the company’s independently developed HB0025 injection will officially commence Phase III clinical trials for advanced/recurrent endometrial cancer. This trial will primarily evaluate the therapeutic efficacy, safety, and tolerability of HB0025 in combination with chemotherapy. To date, the company’s total R&D investment in the HB0025 project is approximately RMB 342 million. According to the announcement, HB0025 is an innovative anti-PD-L1/VEGF bispecific fusion protein that simultaneously targets the tumor immune escape pathway PD-L1 and the tumor angiogenesis pathway VEGF, possessing a dual anti-tumor mechanism of “immune enhancement + anti-angiogenesis”. Currently, there are no completely similar products on the market domestically or internationally. The development of this product will ...
- Source: drugdu
- 43
- March 19, 2026
Industry News | Bowang Pharmaceutical’s siRNA therapy granted Fast Track designation by the FDA

On March 16, Bowang Pharmaceutical announced that its investigational siRNA therapy BW-20805 received Fast Track designation from the U.S. FDA for the treatment of hereditary angioedema (HAE). HAE is a rare genetic disorder that causes sudden, unpredictable swelling in different parts of the body. Severe cases can lead to laryngeal edema, with a mortality rate as high as approximately 40%. BW-20805 is an siRNA therapy targeting prokallikrein (PKK). By targeting PKK mRNA and inhibiting PKK gene expression, it holds promise for providing long-term flare prevention for patients with heart attack (HAE). PKK is currently a well-established therapeutic target in HAE treatment. Recent data presented by Bowang Pharmaceuticals at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting showed that BW-20805 significantly reduces plasma PKK levels and achieves a clinically significant reduction in HAE flare rates. Bowang Pharmaceuticals is currently conducting a Phase 2 clinical trial in adult HAE ...
- Source: drugdu
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- March 19, 2026
Chongqing Yaoyou Pharmaceutical Receives Approval for 2 Billion Yuan Worth of Injectable Drugs

Moxifloxacin hydrochloride sodium chloride injection is an 8-methoxyfluoroquinolone antibiotic with broad-spectrum activity and bactericidal effects. It is suitable for acute bacterial sinusitis, acute exacerbations of chronic bronchitis, community-acquired pneumonia, complicated/uncomplicated skin and skin tissue infections, and complicated intra-abdominal infections caused by susceptible bacteria. According to data from Menet.com , Moxifloxacin Hydrochloride Sodium Chloride Injection is a Class B drug covered by the National Medical Insurance and a National Essential Medicines List. In 2024, its sales in China’s three major terminals and six major markets approached 2 billion yuan, recovering to the level before the implementation of the national centralized procurement policy. However, it experienced a certain degree of decline in the first three quarters of 2025. Sales of Moxifloxacin Hydrochloride Sodium Chloride Injection in China’s Three Major Terminals and Six Major Markets in Recent Years (Unit: RMB 10,000) Source: Menet Pattern Database Currently, more than 30 domestic companies have passed ...
- Source: drugdu
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- March 19, 2026
Chinese Cell Therapy Company Secures Over 100 Million Yuan Seed Funding

Recently, SkyeThera Pharmaceuticals (Shanghai) Co., Ltd. (“SkyeThera” or the “Company”) announced the completion of a seed round financing totaling over 100 million yuan. The round was co-led by Hony Capital and PowerFong Health Fund, with participation from Su Venture Capital, Chenshu Investment, Yingxian Investment and Yida Capital. The proceeds will be mainly allocated to three core areas: the R&D of in vivo multi-target cell therapy candidates, the next-generation universal multi-target CAR-T products for the broad autoimmune disease field, and the development of multi-target CAR-T cell therapy products based on a new-generation rapid autologous manufacturing process. SkyeThera’s founding was driven by keen insights into deep-seated pain points in the cell therapy industry. Although CAR-T therapies have demonstrated remarkable efficacy in hematologic malignancies, they still face three major challenges in real-world clinical practice: high production costs, long manufacturing cycles, and patient relapse due to antigen escape. As an innovative company focused on ...
- Source: drugdu
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- March 19, 2026
March 19, 2026, from the Wechat Public Account “Smart Pharma Hub”

On February 10, 2026, Galux announced the successful completion of a $29 million Series B financing (approximately 42 billion KRW). Following this round, the company’s total cumulative funding reached $47 million (around 68 billion KRW). The Series B round brought together a number of long-term and new institutional investors. Existing investors including InterVest, DAYLI Partners, and PATHWAY Investment participated in the round, while new investors comprised Yuanta Investment, Korea Development Bank (KDB), SL Investment, NCORE Ventures, SneakPeek Investments, Korea Investment & Securities, and Mirae Asset Securities. Galux previously completed an $18 million Series A financing in 2022 (approximately 21 billion KRW), which supported the upgrade of its AI platform and the enhancement of its R&D capabilities. Since then, the company has achieved multiple key R&D and commercial milestones. The successful completion of the Series B round further validates its execution capabilities and growth momentum. Dr. Sang-gyun Kim, Managing Director at ...
- Source: drugdu
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- March 19, 2026
General Practice Conference & Exhibition

Organiser：Reed Exhibitions Australia Pty Ltd Time：May 15 – May 17, 2026 Address：14 Darling Dr, Sydney NSW 2000 Exhibition hall：Sydney Convention and Exhibition Centre Product range: Testing Instruments: Blood pressure and blood glucose monitors, electronic thermometers, blood oxygen detectors, one-drop blood testers, various testing reagents, cardiovascular detectors, blood lipid detectors, stethoscopes, sperm count testers, contraception devices, home electrocardiograms, health detectors, pedometers, and other home-use testing instruments. Health Products: Various health-oriented small home appliances; health textiles with functions such as nanotechnology, magnetic therapy, far-infrared, negative ions, tourmaline, and bamboo charcoal; sleep products, bedding, clothing, protective gear, accessories, and steam sauna series; nano-electrolysis multifunctional water makers, ionized water machines, direct drinking water machines, central water purification equipment, nano-ecological antibacterial cups, water treatment and environmental protection series; health-preserving activated cups, energy cups, wellness cups, and other health and wellness products. Nursing Equipment: Various rehabilitation and nursing equipment, barrier-free equipment, mobility aids, hearing and ...
- Source: drugdu
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- March 19, 2026

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