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Lenvatinib Mesylate Capsules Receive Drug Registration Certificate

Nanfang Finance News, August 7th – Lu Kang PharmaceuticalThe company announced that it has received a Drug Registration Certificate for Lenvatinib Mesylate Capsules issued by the National Medical Products Administration. This product is used to treat patients with unresectable hepatocellular carcinoma who have not previously received systemic therapy. https://finance.eastmoney.com/a/202608073835336556.html
- Source: drugdu
- 59
- August 10, 2026
Loxoprofen Sodium Patch Receives Drug Registration Certificate

　　Fuyuan Pharmaceutical(601089.SH) announced that it has received a Drug Registration Certificate for Loxoprofen Sodium Patches from the National Medical Products Administration, approving the production of the drug. This drug is used for anti-inflammatory and analgesic purposes for osteoarthritis, muscle pain, and swelling or pain caused by trauma. As of the date of the announcement, the company’s cumulative R&D investment in this drug is RMB 11.7065 million. Sales of Loxoprofen Sodium Patches in China’s three major terminal markets and six major markets are projected to reach approximately RMB 901 million by 2025. https://finance.eastmoney.com/a/202608073835312137.html
- Source: drugdu
- 64
- August 10, 2026
Subsidiary obtains drug registration certificate for injectable multivitamins (12)

　　Wei Xinkang(603676.SH) announced that its wholly-owned subsidiary, Baiyi Pharmaceutical, received approval from the National Medical Products Administration for injectable multivitamins .(12) Drug Registration Certificate. This drug is a Class 4 chemical drug and is considered to have passed the consistency evaluation. In 2025, the sales of this drug in domestic public medical institutions reached RMB 1.601 billion, and the cumulative R&D investment as of the end of July 2026 was RMB 11.3139 million. https://finance.eastmoney.com/a/202608073835199693.html
- Source: drugdu
- 64
- August 10, 2026
【EXPERT Q&A】How should a post-market supervision plan for in vitro diagnostic products be established under the EU IVDR regulation?

Drugdu.com expert’s response: Many IVD enterprises, when preparing for EU market compliance, tend to prioritize pre-market requirements such as CE certification, technical documentation and performance evaluation. However, regulatory obligations do not terminate once the product is placed on the market. In accordance with the EU IVDR, manufacturers are mandated to establish a Post-Market Surveillance (PMS) system to continuously collect post-launch real-world usage data, safety performance and potential risks of the device, and implement corresponding corrective actions based on the feedback. For IVD enterprises planning to access the EU market, the post-market surveillance plan shall be established as follows: 1. Define the objectives and scope of post-market surveillance in advance Prior to developing the PMS plan, the enterprise shall explicitly determine: The product portfolio covered by the surveillance scope; The sales territories of the products; Target user groups; Risk class of each product; Key issues requiring prioritized attention. Different IVD products ...
- Source: drugdu
- 64
- August 10, 2026
【EXPERT Q&A】What are the key requirements of the EU CE for the design and development control of medical devices?

Drugdu.com expert’s response: The key requirements of EU CE for medical device design and development control, which are centered on full-process compliance management, are mainly divided into the following modules: I. Planning Phase Before initiating the design, a complete project plan shall be formulated, clarifying project objectives, timelines, resource allocation, risk assessment and verification protocols. Accurately define the design inputs based on user requirements, EU regulations, safety standards and technical specifications, and specify core indicators such as the device’s performance, functions and safety. II. Implementation Phase Produce clear and actionable design deliverables, including product drawings, technical specifications, process flows and other contents to facilitate subsequent production and inspection. Organize regular cross-departmental design reviews to ensure that design outputs fully meet the requirements of design inputs, and simultaneously optimize design details. Implement full-process risk management, identify potential risks throughout the design, production and usage processes, and formulate corresponding risk control measures. ...
- Source: drugdu
- 83
- August 7, 2026
ISPE Singapore Affiliate

Organiser： International Society for Pharmaceutical Engineering (ISPE) Time：August 19-21, 2026 Address：1 Raffles Blvd, Singapore 039593 Exhibition hall：Suntec Convention & Exhibition Centre Product range: Pharmaceutical Raw Materials‌: Pharmaceutical raw materials, chemical intermediates, excipients, active ingredients, alkaloids, amino acids, antibiotics, antibacterial preservatives, enzymes, hormones and synthetic products, capsules, animal and plant extracts, humectants, antioxidants, catalysts, emulsifiers and solubilizers, herbal teas, intermediates, ointments, phospholipids, sweeteners, lubricants, coating agents, pigments, flavors and fragrances, interferons, diagnostic reagents, fine chemicals, colloids, medicinal plants, sera and vaccines, suppositories and tablets, contract research, custom manufacturing, marketing services, etc. ‌Pharmaceutical Industry‌: Raw materials and components for the pharmaceutical industry, intermediates, pharmaceutical equipment, pharmaceutical packaging, laboratory equipment and reagents, control instruments and equipment, clinical research, cleanroom technology, pharmaceutical engineering, personal protective equipment, quality inspection equipment and consumer goods, auxiliary software required for the pharmaceutical industry. About ISPE Singapore Affiliate： ISPE Singapore Affiliate is the largest and most respected ...
- Source: drugdu
- 76
- August 6, 2026
【EXPERT Q&A】Why do buyers still not know your advantages after uploading dozens of peptide products?

Drugdu.com expert’s response: Many peptide API enterprises have a common habit when launching overseas promotion: uploading their entire existing product catalog at once, showcasing dozens of varieties or even hundreds of CAS numbers in a single batch. Their logic is straightforward — the broader the product coverage, the higher the chance of being discovered by overseas buyers. However, in actual platform operation, they often encounter a counterintuitive situation: despite a large number of products and considerable page views, the volume of truly matched inquiries remains low. The problem rarely lies in insufficient product quantity; instead, it stems from the failure to present the information buyers need to confirm quickly after landing on the page. There is a distinct difference between peptide API procurement and general chemical product sourcing. Buyers do not judge a supplier’s strength merely by the scale of its product portfolio. What they prioritize are: Whether the enterprise ...
- Source: drugdu
- 83
- August 5, 2026
its stock price has shrunk by 90% from its issue price, and although it has finally received approval for its first product, the market landscape has already changed.

Kang Le Guardian (i.e., *ST Kang Le)(BJ920575, stock price 4.71 yuan, market value 1.323 billion yuan) has finally ushered in its long-awaited first commercial product. Delivery letter of drug approval certificate published by the National Medical Products Administration on July 30Information shows that the trivalent human papillomavirus vaccine from Health Guard (Kunming) Biotechnology Co., Ltd.(Escherichia coli) has been approved, with approval number S20260057, and approval date July 28. This product covers HPV types 16, 18, and 58. KangLeGuardian had been waiting for this moment for far too long. In March 2023, KangLeGuardian went public on the Beijing Stock Exchange with an issue price of 42 yuan per share, becoming the first HPV stock on the Beijing Stock Exchange. That was also a high point for HPV vaccines —more than 58 million doses were administered in China throughout the year, and HPV vaccines became the vaccine category with the largest increase ...
- Source: drugdu
- 93
- August 4, 2026
China’s first generic tiotropium bromide inhalation spray approved.

China Securities Intelligent Finance News: BrightGene Pharmaceutical(688166) announced on the evening of July 31 that its holding subsidiary, Aitemei (Suzhou) Pharmaceutical Technology Co., Ltd., recently received a Drug Registration Certificate for Tiotropium Bromide Inhalation Spray issued by the National Medical Products Administration. The specification is 60 sprays per bottle, the registration category is chemical drug category 4, and the drug approval number is valid until July 27, 2031. The announcement indicates that this drug is suitable for maintenance treatment of chronic obstructive pulmonary disease (COPD) and related dyspnea, and can reduce acute exacerbations of COPD. The original manufacturer is Boehringer Ingelheim, and currently only the original imported version is available on the market. The National Medical Products Administration (NMPA) website shows that there are currently no generic versions of this drug available in China, making Boehringer Ingelheim the first company to receive approval for its market launch in the country. ...
- Source: drugdu
- 82
- August 4, 2026
Ibrutinib tablets receiving drug registration certificate is considered equivalent to passing the consistency evaluation

China Securities Intelligent Finance Huabang Health(002004) announced on the evening of July 31 that its wholly-owned subsidiary, Chongqing Huabang Pharmaceutical Co., Ltd., recently received the Drug Registration Certificate for Ibrutinib tablets issued by the National Medical Products Administration. The specifications are 0.14g and 420mg, and the registration category is Class 3 chemical drug, which is regarded as passing the consistency evaluation of generic drug quality and efficacy. The announcement indicates that this drug is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy; patients with chronic lymphocytic leukemia/small lymphocytic lymphoma; patients with Waldenström macroglobulinemia who have received at least one prior therapy, or those who are unsuitable for chemoimmunotherapy .This product is a first-line treatment for patients with Waldenström macroglobulinemia; when used in combination with rituximab, it is suitable for the treatment of patients with Waldenström macroglobulinemia. The company stated that ...
- Source: drugdu
- 76
- August 4, 2026

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