CENTEK(SZ:000931) Shang Hai Zheng Quan Bao·2026-02-09 19:00Core Viewpoint - Beijing Zhongguancun Science and Technology Development (Holding) Co., Ltd. announced that its subsidiary, Beijing Huasu Pharmaceutical Co., Ltd., has successfully passed the consistency evaluation for the generic drug Tramadol Hydrochloride Tablets (50mg) [1][2]. Group 1: Drug Approval Details - The drug name is Tramadol Hydrochloride Tablets, in tablet form, with a specification of 50mg [1]. - The approval notice number is 2026B00624, and the drug is classified as a chemical drug [1]. - The approval includes changes to the prescription, manufacturing process, production batch, quality standards, and shelf life [1]. Group 2: Market Context - The original drug has not been marketed in China, but there are currently eight generic versions approved, with three having passed the consistency evaluation [2]. - Beijing Huasu is the third domestic company to receive approval for this drug's consistency evaluation [2]. Group 3: Financial Investment - The total research and development investment for the consistency evaluation project of Tramadol Hydrochloride Tablets has reached approximately 5.9 million yuan [3]. Group 4: Impact on Company Performance - The approval is expected to enhance the market competitiveness of the drug and positively impact the company's operating performance [5]. - The company emphasizes the importance of drug research and development, maintaining strict quality control throughout the drug development, manufacturing, and sales processes [5].