[Beijing, China – March 18, 2026] Huahui Anjian announced that its independently developed, world’s first-in-class ribevittamab injection (trade name: Huayounuo), targeting PreS1 of hepatitis B and hepatitis D viruses, was successfully prescribed globally on March 16 at Beijing Friendship Hospital affiliated with Capital Medical University. This marks the official entry of my country’s first hepatitis D treatment drug into the clinical application stage. As a domestically developed original drug with independent innovation throughout the entire process from “target mechanism” to “drug creation,” ribevittamab will provide a more effective and accessible treatment option for patients with chronic hepatitis D virus (HDV) infection in my country and more countries along the “Belt and Road” initiative. picture Ribevirtamaab received conditional approval from the National Medical Products Administration (NMPA) on January 20, 2026, for the treatment of adult patients with chronic hepatitis D virus (HDV) infection, with or without compensated cirrhosis. This product is ...
On March 19, 2026, Novartis announced that its innovative biologic, Zorla® ( omalizumab), a pre-filled auto-injector pen, has been approved by the National Medical Products Administration for the treatment of adults and adolescents (12 years and older) with chronic spontaneous urticaria (CSU) and patients diagnosed with IgE (immunoglobulin E)-mediated asthma who still have symptoms after treatment with H1 antihistamines. (This product is indicated for adults and adolescents (12 years and older) with moderate to severe persistent allergic asthma whose symptoms are not effectively controlled after treatment with inhaled corticosteroids and long-acting inhaled β2 – adrenergic receptor agonists.) According to reports, Zorula has been on the global market for over 20 years, with multiple dosage forms and indications, and is widely used in more than 90 countries and regions, including China. https://www.vbdata.cn/1519067858
On March 20, Rigerna Therapeutics (Suzhou Xuanjing Biotechnology Co., Ltd.) announced the completion of a Pre‑A financing round totaling over 200 million yuan, led by Kangjun Capital. Participating investors include Delian Capital, Huatai‑GenScript Fund, Jinyi Fuxin, Guohai Innovation Capital, Lenovo Capital, and existing shareholder Yuanxi Haihe Fund, Xuanjing Biological. Founded in 2022, Rigerna Therapeutics is innovation‑driven and focuses on nephrology and metabolic diseases, aiming to become a leader and innovator in the small nucleic acid (oligonucleotide) pharmaceutical field Xuanjing Biological. With forward‑looking strategic planning, its lead pipeline has entered Phase II clinical trials and is poised to become the world’s first approved small nucleic acid drug for IgA nephropathy. Addressing unmet clinical needs in renal and metabolic disorders, Rigerna is developing multiple First‑in‑class programs, building a multi‑layered, gradient pipeline matrix. The completion of this financing round and advancement of several BD collaborations have secured substantial cash reserves, laying a solid ...
Recently, TQB6457 Injection, a Class 1 innovative drug developed by Chia Tai Tianqing Pharmaceutical Group, a core subsidiary of China Biologic Products Holdings, Inc. (1177.HK), has been granted clinical trial implied approval by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of advanced malignant tumors. As the world’s first fixed-dose combination of a CCR8 monoclonal antibody and a PD‑1 antibody to enter clinical research, this product is designed to replace combination therapy with a single agent, helping to improve medication adherence among patients with advanced tumors and overcome treatment limitations. CCR8 is a promising target specifically and highly expressed on the surface of regulatory T cells (Tregs) in the tumor microenvironment, and plays a key role in recruiting Tregs to tumor sites. PD‑1 is a canonical immune checkpoint protein; tumor cells can trigger immunosuppression by binding PD‑1 via PD‑L1. As a dual-targeted ...
Sinopharm Accord continues senior management reshuffle. 01 Sinopharm Accord Realigns Its Leadership Team On March 17, Sinopharm Accord Co., Ltd. (“Sinopharm Accord”) announced that Wang Chu, Deputy General Manager, had resigned due to work relocation and would not hold any other positions at the company after resignation. Wang Chu was primarily responsible for commercial sales. He assumed the post of Deputy General Manager of Sinopharm Accord in March 2025 and left after only one year in office. He currently remains the legal representative of Sinopharm Holding Guangzhou Co., Ltd., a wholly-owned subsidiary of Sinopharm Accord. This marks the second deputy general manager to depart Sinopharm Accord in the past six months. In November 2025, Chen Changbing, Deputy General Manager in charge of strategic planning, investment and M&A, left ahead of schedule; his original term was set to expire in July 2027. Following Wang Chu’s departure, Sinopharm Accord’s senior management team ...
From an aggressive M&A spree to a now selective asset manager, China Resources Pharmaceutical has begun to shift its logic in selecting and exiting investment targets. 01 Ending a Decade-Long Partnership China Resources Pharmaceutical Continues Asset Divestment On March 16, China Resources Pharmaceutical announced a plan to sell a 5.88% equity stake in Hefei Tianmai Biotech Co., Ltd. (“Tianmai Biotech”) via public listing at a price of 510 million yuan. This marks the second disposal of Tianmai Biotech shares by China Resources Pharmaceutical in just over a month. In February this year, it put a 17.87% stake up for transfer at a reserve price of 1.42 billion yuan. The combined reserve prices of the two transactions total 1.93 billion yuan, and the two deals are independent of each other. Data from Qichacha shows that China Resources Pharmaceutical Investment, a wholly-owned subsidiary of China Resources Pharmaceutical, is the largest shareholder ...
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, ...
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 ...
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 ...
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 ...
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