Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Lidocaine and Prilocaine Cream, indicating a significant advancement in its product offerings [1] Group 1: Product Approval - The approved product, Lidocaine and Prilocaine Cream, is a compound formulation used for local anesthesia in various medical procedures [1] - Indications for use include skin local anesthesia for needle punctures, such as catheter insertion or blood sampling, and superficial surgical procedures [1] - The cream is also indicated for cleaning and debridement of leg ulcers, showcasing its versatility in clinical applications [1]

Core Viewpoint - Pro Pharmaceutical Co., Ltd. has received a drug registration certificate for Cefdinir capsules from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Group 1: Company Developments - The company’s subsidiary, Zhejiang Pro Pharmaceutical Co., Ltd., is the entity that received the drug registration certificate for Cefdinir capsules [1] - Cefdinir capsules are indicated for infections caused by various bacteria, including Staphylococcus, Streptococcus, and Escherichia coli, among others [1] Group 2: Product Indications - The indications for Cefdinir capsules include infections such as pharyngitis, tonsillitis, acute bronchitis, pneumonia, otitis media, sinusitis, pyelonephritis, cystitis, and gonococcal urethritis [1] - Additional indications cover conditions like pelvic inflammatory disease, intrauterine infections, and various skin and soft tissue infections [1]

Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. has received a drug registration certificate for Angong Niuhuang Pills from the Vietnamese Ministry of Health, which will allow its subsidiary to expand its market presence in Vietnam [1][3]. Group 1: Drug Information - The drug Angong Niuhuang Pills is a prescription traditional Chinese medicine used for clearing heat and detoxifying, as well as calming and opening the orifices [2]. - The registration number for Angong Niuhuang Pills is VNCT-00006-25, and it is manufactured by Guangzhou Baiyunshan Zhongyi Pharmaceutical Co., Ltd. [1]. Group 2: Financial Performance - In 2024, the sales revenue of Angong Niuhuang Pills in China reached RMB 498,242 million, while the sales revenue for Zhongyi Pharmaceutical was RMB 15,611.83 million [2]. - The total research and development investment for the Angong Niuhuang Pills project by Zhongyi Pharmaceutical has reached approximately RMB 3,279.81 million (unaudited) [2]. Group 3: Market Impact - The registration of Angong Niuhuang Pills is expected to enhance the market competitiveness of the company’s products and facilitate the expansion of its business in Vietnam [3]. - The impact of this registration on the company's current performance is not expected to be significant [3].

Core Viewpoint - Zhejiang Jiuzhou Pharmaceutical Co., Ltd. has received a drug registration certificate for Tanshinone IIA from the National Medical Products Administration, which enhances its product pipeline and market competitiveness [1][3]. Drug Basic Information - The drug name is Tanshinone IIA, available in tablet form with specifications of 60mg and 30mg [1]. - It is classified as a Class 4 chemical drug with registration numbers H20255929 and H20255930, valid until November 11, 2030 [1]. - The drug is produced by Jiuzhou Biopharmaceutical (Taizhou) Co., Ltd., located in Taizhou, Zhejiang Province [1]. Market Context - Tanshinone IIA is an oral anticoagulant primarily used for preventing strokes and systemic embolism in patients with non-valvular atrial fibrillation, as well as treating or preventing deep vein thrombosis and pulmonary embolism [2]. - The drug was first developed by Daiichi Sankyo in Japan and launched in April 2011 [2]. - In 2023, the sales revenue of Tanshinone IIA in domestic sample hospitals and pharmacies was approximately RMB 361 million [2]. - The company has invested about RMB 14.41 million in the research and development of Tanshinone IIA [2]. Impact on the Company - The acquisition of the drug registration certificate for Tanshinone IIA will enrich the company's product pipeline and enhance its market competitiveness [3]. - However, this development is not expected to have a significant short-term impact on the company's performance [3].

Core Viewpoint - The company has received approval for the registration certificate of Tofacitinib Tosylate Tablets, enhancing its product pipeline and market competitiveness [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Jiuzhou Biopharmaceutical (Taizhou) Co., Ltd., has obtained the drug registration certificate from the National Medical Products Administration for Tofacitinib Tosylate Tablets [1] - Tofacitinib Tosylate is an oral anticoagulant primarily used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment or prevention of deep vein thrombosis and pulmonary embolism [1] Group 2: Market Impact - The acquisition of the drug registration certificate will further enrich the company's product pipeline and help enhance its market competitiveness [1] - The recent approval is not expected to have a significant short-term impact on the company's performance [1] Group 3: Industry Characteristics - The production and sales of pharmaceutical products are influenced by market conditions, industry policies, and supply-demand relationships, which introduces a degree of uncertainty [1]

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received the drug registration certificate for Ezetimibe and Atorvastatin Calcium Tablets (I), which will enhance the company's product line and market competitiveness [1][5]. Drug Registration Certificate Details - The drug registration certificate (Certificate No. 2025S03344) was issued by the National Medical Products Administration (NMPA) for Ezetimibe and Atorvastatin Calcium Tablets (I), which contains 10mg of Ezetimibe and 10mg of Atorvastatin Calcium per tablet [1][2]. - The drug is indicated for hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) and was first approved by the FDA in May 2013 [1][2]. R&D Investment - The total R&D investment for this drug has reached RMB 5.0458 million (unaudited) as of the date of the announcement [3]. Market Status of Similar Drugs - According to data from Minai Network, the sales revenue of Ezetimibe and Atorvastatin Calcium Tablets in China for the first half of 2025 was approximately RMB 8.64 million, with sales from urban public hospitals and county-level public hospitals accounting for RMB 6.74 million [4]. - Sales from urban community centers and township health clinics were RMB 1.77 million, while urban pharmacies and online pharmacies contributed RMB 0.13 million [4].

Core Viewpoint - Fangsheng Pharmaceutical has received approval from the National Medical Products Administration for the production of Indobufene Tablets, enhancing its product line in cardiovascular medications and increasing market competitiveness, although short-term sales impact on performance is expected to be limited [1] Summary by Categories Product Approval - The company has been granted a drug registration certificate for Indobufene Tablets, with a specification of 0.2g and a validity period until November 3, 2030 [1] Research and Development Investment - Cumulative R&D investment for the project has reached approximately 28.72 million yuan [1] Sales Performance - In the first half of 2025, the total sales for the drug in hospitals and retail pharmacies are projected to be 1.192 billion yuan and 266 million yuan, respectively [1] Market Impact - The approval enriches the company's cardiovascular medication product line and enhances its market competitiveness, but various factors may influence sales performance, leading to a limited short-term impact on overall performance [1]

Core Viewpoint - Beilu Pharmaceutical (300016.SZ) has received approval from the National Medical Products Administration for the iodine-based contrast agent, Iodine Meper, which is expected to drive significant sales growth in the coming years [1] Group 1: Product Details - Iodine Meper is a non-ionic monomer X-ray contrast agent developed by Italy's Bracco, characterized by excellent physicochemical properties, including the lowest osmotic pressure and lower viscosity compared to similar agents at the same concentration [1] - The product is stable in its physicochemical properties and does not require the addition of chelating agents [1] - Indications for Iodine Meper include intravenous urography, CT scans, conventional angiography, and various forms of vascular imaging for both adults and children [1] Group 2: Market Potential - Iodine Meper has been included in the National Medical Insurance Class B directory, enhancing its market accessibility [1] - According to data from Minet, sales in China's three major terminal markets have been growing at double-digit rates, with projected sales exceeding 1.1 billion yuan in 2024, representing a year-on-year growth of approximately 32% [1] - In the first quarter of 2025, sales are expected to surpass 300 million yuan, with a year-on-year growth of about 39% [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Alendronate Sodium Oral Solution, which is indicated for the treatment of osteoporosis in postmenopausal women and men, aimed at preventing hip and vertebral fractures [1] Company Summary - The newly approved Alendronate Sodium Oral Solution is designed to increase bone mass and prevent fractures in specific patient populations [1] - The projected sales revenue for Alendronate Sodium in 2024 across major distribution channels, including public hospitals, grassroots medical institutions, and retail pharmacies, is estimated to reach RMB 720 million [1]

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. announced that its wholly-owned subsidiary, Zhejiang Aisheng Pharmaceutical Co., Ltd., has received a drug registration certificate from the National Medical Products Administration for Dydrogesterone Tablets, which will enhance the company's product line and market competitiveness [1][4]. Drug Registration Certificate Details - The drug registration certificate for Dydrogesterone Tablets (10mg) was issued by the National Medical Products Administration, indicating that the drug has passed the consistency evaluation as per national policies [1]. Drug Information - Dydrogesterone is an orally absorbable synthetic progestogen, originally developed by Solvay Pharmaceuticals and approved for market in Portugal in July 1961. It was approved for sale in China in December 2002 for treating endogenous progesterone deficiency and supporting luteal function in assisted reproductive technology [1][2]. R&D Investment - As of the announcement date, Zhejiang Aisheng has invested a total of RMB 5.3716 million (approximately 0.537 million) in the research and development of this drug [2]. Market Status of Similar Drugs - According to data from Minai Network, the sales revenue of Dydrogesterone Tablets in China's three major terminal markets is approximately RMB 2.57 billion (approximately 25.70 million), with public hospitals accounting for RMB 2.20 billion (approximately 22.01 million), community health centers and township hospitals for RMB 61 million (approximately 0.61 million), and retail pharmacies and online pharmacies for RMB 308 million (approximately 3.08 million) [3].