仿制药一致性评价
Search documents
中国医药:盐酸林可霉素注射液通过一致性评价
Di Yi Cai Jing· 2025-09-23 08:12
Core Viewpoint - The announcement highlights that Tianfang Pharmaceutical, a subsidiary of China Pharmaceutical, has successfully passed the consistency evaluation for the quality and efficacy of its Lincomycin Hydrochloride Injection, which is expected to enhance its market competitiveness and expand market share [1] Group 1: Product Development - Tianfang Pharmaceutical's Lincomycin Hydrochloride Injection received acceptance for consistency evaluation by the National Medical Products Administration in July 2024 [1] - The company has invested approximately 6.08 million RMB (about 0.608 million) in the development of this product as of the announcement date [1] Group 2: Market Potential - The domestic sales revenue for public hospitals and grassroots medical terminals in 2024 is projected to be around 77 million RMB (approximately 0.77 billion) [1] - Tianfang Pharmaceutical's sales revenue for this product is approximately 15.32 million RMB (about 1.532 million) [1] Group 3: Competitive Advantage - Passing the consistency evaluation is expected to improve the market competitiveness of the Lincomycin Hydrochloride Injection, allowing for further market share expansion [1]
江苏吴中医药发展股份有限公司关于盐酸林可霉素注射液通过仿制药一致性评价的公告
Shang Hai Zheng Quan Bao· 2025-09-22 20:34
Core Viewpoint - Jiangsu Wuzhong Pharmaceutical Development Co., Ltd. announced that its subsidiary has received approval for the consistency evaluation of Lincomycin Hydrochloride Injection, enhancing its market competitiveness and sales potential [1][3]. Drug Basic Information - Drug Name: Lincomycin Hydrochloride Injection - Dosage Form: Injection - Specification: 2ml: 0.6g (calculated as C18H34N2O6S) - Approval Number: National Drug Approval No. H32021365 - Registration Category: Chemical Drug - Holder of Marketing Authorization: Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. Suzhou Pharmaceutical Factory [1]. Market and Financial Impact - The total sales of Lincomycin Hydrochloride Injection in hospitals nationwide for 2024 are approximately 22.1165 million yuan [3]. - The drug is included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024) as a Class A variety [3]. - As of August 2025, the company has invested approximately 3.1324 million yuan in the research and development of Lincomycin Hydrochloride Injection [3]. Regulatory and Clinical Use - The drug is indicated for severe infections caused by sensitive strains of Streptococcus, Pneumococcus, and Staphylococcus, specifically for patients allergic to penicillin or deemed unsuitable for penicillin use [2]. - Lincomycin Hydrochloride Injection was first approved by the FDA on December 29, 1964, and has since been approved in various countries, including Japan and European nations [2]. Competitive Advantage - The approval of the drug through the consistency evaluation is expected to positively impact its market sales and competitiveness, as healthcare institutions are encouraged to prioritize the procurement of drugs that have passed this evaluation [3].
海欣股份:APDC三期临床试验正在探索解决方案
Quan Jing Wang· 2025-09-19 10:22
Group 1 - The core viewpoint of the article highlights the recent developments in HaiXin Co., Ltd.'s pharmaceutical sector, particularly in the area of oncology drug research and development [1] - The chairman of HaiXin Co., Ltd., Deng Haibin, stated that the company's pharmaceutical subsidiaries are primarily traditional generic drug companies, focusing on post-marketing clinical trial evaluations of existing key products and promoting the consistency evaluation of generic drugs [1] - Regarding the clinical trial progress of HaiXin Biotech's APDC, it was mentioned that the design of the Phase III clinical trial was established a long time ago, leading to difficulties in patient enrollment, and the company is currently exploring solutions to this issue [1]
国药现代最新公告:马来酸依那普利片(5mg)通过仿制药一致性评价
Sou Hu Cai Jing· 2025-09-17 09:46
Core Viewpoint - The company, China National Pharmaceutical Group Modern (国药现代), has received approval from the National Medical Products Administration for the supplementary application of Enalapril Maleate Tablets (5mg), which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Product Information - Enalapril Maleate Tablets are an angiotensin-converting enzyme (ACE) inhibitor primarily used for treating essential hypertension, renovascular hypertension, and symptomatic heart failure [1] - The projected sales for Enalapril Maleate Tablets in public medical institutions and urban pharmacies in China for 2024 is estimated at RMB 164 million [1] Group 2: Financial Investment - The cumulative R&D investment for this project amounts to approximately RMB 15.37 million (unaudited) [1] - The approval of the 5mg formulation is expected to facilitate future market expansion and sales of the product [1] Group 3: Impact on Company Performance - The recent approval is not anticipated to have a significant impact on the company's current operating performance [1]
天圣制药集团股份有限公司 2025年第三次临时股东大会决议公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-14 22:40
Group 1 - The company held its third extraordinary general meeting of shareholders on September 12, 2025, with no resolutions being rejected [1][2][6] - A total of 100 shareholders participated in the meeting, representing 113,225,082 shares, which is 35.6054% of the total voting shares [7] - The meeting approved several resolutions, including amendments to the company's articles of association and governance systems, with significant support from shareholders [11][12][14][16][18][20] Group 2 - The company received an administrative penalty notice from the China Securities Regulatory Commission (CSRC) regarding violations of information disclosure laws, specifically for inflating profits in 2017 and 2018 [24][25] - The inflated profits amounted to 92,204,254.47 yuan in 2017 and 28,823,001.51 yuan in 2018, representing 30.21% and 20.61% of the reported profits for those years, respectively [25][27] - The company and several executives face fines and potential market bans due to their involvement in these violations, with the actual controller facing a lifetime ban from the securities market [31][34] Group 3 - The company's stock will be subject to additional risk warnings starting September 15, 2025, due to the identified violations, although it will not be suspended from trading [38][40] - The company plans to enhance its internal controls and compliance measures to prevent future violations and improve governance [42]
国药现代:碳酸氢钠注射液增加规格并通过仿制药一致性评价
Zhi Tong Cai Jing· 2025-09-12 08:59
Core Viewpoint - The company, China National Pharmaceutical Group Modern (600420.SH), announced that its wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for a supplemental application regarding sodium bicarbonate injection, which includes an increase in specifications and has passed the consistency evaluation for generic drug quality and efficacy [1]. Group 1 - The sodium bicarbonate injection is classified as an antacid [1]. - Indications for sodium bicarbonate injection include: (1) treatment of metabolic acidosis; (2) prevention of uric acid kidney stones, reduction of nephrotoxicity from sulfonamides, and prevention of hemoglobin deposition in renal tubules during acute hemolysis; (3) intravenous infusion for non-specific treatment of certain drug poisonings, such as barbiturates, salicylates, and methanol [1].
哈药股份(600664.SH):所属企业药品通过仿制药一致性评价
Ge Long Hui A P P· 2025-09-11 07:52
Core Viewpoint - Harbin Pharmaceutical Group's subsidiary, Sanjing Mingshui, has received approval from the National Medical Products Administration for the supplementary application of Lercanidipine tablets, which have passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval and Market Impact - The approval of Lercanidipine tablets (4mg) enhances the market competitiveness of the product and is expected to increase its market share [1] - The drug is a highly selective calcium channel blocker that primarily dilates peripheral small arteries, reducing peripheral vascular resistance and lowering blood pressure [1] - The approval aligns with national policies that provide greater support for drugs that pass the consistency evaluation in areas such as medical insurance payments and procurement by medical institutions [1] Group 2: Strategic Implications for the Company - The successful evaluation of Lercanidipine tablets provides valuable experience for the company in conducting future consistency evaluations for other products [1]
上海医药集团股份有限公司 关于二羟丙茶碱注射液通过仿制药一致性评价的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-05 04:44
Group 1 - The company Shanghai Pharmaceutical Group Co., Ltd. announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration approving the supplementary application for the drug Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1][2] - The drug Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, wheezing bronchitis, and obstructive pulmonary emphysema, and it was developed by Eisai Co., Ltd. and launched in Japan in October 1952 [2] - As of the announcement date, the company has invested approximately RMB 3.05 million in research and development for this drug [2] Group 2 - The approval of the drug's consistency evaluation is expected to enhance its market share and competitiveness, as products that pass this evaluation will receive greater support in medical insurance payments and procurement by medical institutions [2] - The total procurement amount for Dihydroxypropyl Theophylline Injection (2ml:0.3g) in hospitals in mainland China for 2024 is reported to be RMB 9.737 million [2]
上海医药(601607.SH):二羟丙茶碱注射液通过仿制药一致性评价
智通财经网· 2025-09-04 07:44
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. (referred to as "Xinyi Jinzhu"), has received a "Drug Supplement Application Approval Notice" from the National Medical Products Administration (NMPA) for its Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, and relief of wheezing symptoms [1] - The drug can also be used for wheezing caused by cardiogenic pulmonary edema [1] - Dihydroxypropyl Theophylline Injection was developed by Eisai Co., Ltd. and was launched in Japan in October 1952 [1] Group 2 - In August 2024, Xinyi Jinzhu submitted a supplementary application to the NMPA for the new specification and combined consistency evaluation of the generic drug, which was accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.05 million in research and development costs for this drug [1]
上海医药:二羟丙茶碱注射液通过仿制药一致性评价
Zhi Tong Cai Jing· 2025-09-04 07:39
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. (referred to as "Xinyi Jinzhu"), has received a Supplementary Application Approval Notice from the National Medical Products Administration (NMPA) for its Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, and relief of wheezing symptoms [1] - The drug can also be used for wheezing caused by cardiogenic pulmonary edema [1] - The drug was developed by Eisai Co., Ltd. and was launched in Japan in October 1952 [1] Group 2 - In August 2024, Xinyi Jinzhu submitted a supplementary application to the NMPA for the new specification and consistency evaluation of the generic drug, which has been accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.05 million in research and development costs for this drug [1]