PharmaFocus Today – Page 8 – media

Rosuvastatin Ezetimibe Tablets (I) Receive Registration Approval

Shanghai Securities News (China Securities Network) – Peking University MedicineOn the evening of October 19th, the company announced that it had recently received a Drug Registration Certificate issued by the National Medical Products Administration. Its application for “Rosuvastatin Ezetimibe Tablets (I)” has been reviewed and found to meet the relevant requirements for drug registration, and has been approved for registration. It is understood that the drug is classified as a Class 4 chemical drug, and each tablet contains 10mg of rosuvastatin calcium (calculated as C22H28FN3O6S) and 10mg of ezetimibe. Data shows that rosuvastatin-ezetimibe tablets (I) are a compound preparation composed of rosuvastatin (an HMG-CoA reductase inhibitor) and ezetimibe (a cholesterol absorption inhibitor). Their mechanisms of action are complementary; by inhibiting cholesterol absorption and synthesis, they lower plasma levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), while increasing high-density lipoprotein ...
- Source: drugdu
- 95
- October 20, 2026
北大医药：瑞舒伐他汀依折麦布片(Ⅰ)获注册批件

上证报中国证券网讯北大医药10月19日晚间公告，近日公司收到国家药品监督管理局核准签发的有关《药品注册证书》，其申报的“瑞舒伐他汀依折麦布片(I)” 经审查，符合药品注册的有关要求，批准注册并发给药品注册证书。据悉，该药品注册分类为化学药品4类，规格为每片含瑞舒伐他汀钙10mg(按C22H28FN3O6S计)与依折麦布10mg。资料显示，瑞舒伐他汀依折麦布片(Ⅰ)是由瑞舒伐他汀（HMG-CoA还原酶抑制剂）和依折麦布（胆固醇吸收抑制剂）组成的复方制剂，二者作用机制互补，通过抑制胆固醇的吸收和合成，降低血浆总胆固醇（T-C）、低密度脂蛋白胆固醇（LDL-C）、载脂蛋白B（ApoB）、甘油三酯（TG）和非高密度脂蛋白胆固醇（non-HDL-C）的水平，并能提高高密度脂蛋白胆固醇（HDL-C）水平。其主要用于高胆固醇血症、纯合子型家族性高胆固醇血症（HoFH）的治疗。北大医药表示，上述药物注册批件的获得，进一步丰富了公司现有产品布局，有利于提升公司在慢病领域产品市场的竞争力，对公司未来业绩提升有积极作用。 Source: https://finance.eastmoney.com/a/202610193900214984.html
- Source: drugdu
- 88
- October 20, 2026
Telix teams up with Ekalia (IBA-Framatome JV) to scale up astatine-211 production in the U.S., advancing targeted alpha therapy

On 19 October 2026, Telix Pharmaceuticals Limited (ASX: TLX; NASDAQ: TLX) and Ekalia, a joint venture between IBA (Ion Beam Applications S.A., Euronext) and Framatome, announced a collaboration to advance scalable U.S. production of astatine-211 (211At), an alpha-emitting radioisotope being investigated for targeted alpha therapy (TAT). The collaboration establishes a framework for a dedicated U.S. source of 211At, a scarce, next-generation alpha-emitting isotope whose broader adoption has been constrained by limited production capacity. Under the arrangement, the first IBA alpha-beam cyclotron will be installed and operated at Telix’s RLS Radiopharmacies site in Trevose, near Philadelphia, Pennsylvania. Leveraging Telix’s vertically integrated U.S. manufacturing and distribution platform, the framework provides for the parties to evaluate additional installations across RLS sites as demand for 211At develops. The alliance brings together IBA’s specialized alpha-beam cyclotron technology, Framatome’s nuclear and isotope-production expertise, and Telix’s U.S. radiopharmacy and last-mile infrastructure, clinical portfolio and radiopharmaceutical development capabilities. ...
- Source: drugdu
- 102
- October 19, 2026
Haihe Biopharma’s oral paclitaxel (Bairuisu) approved for breast cancer, the world’s first oral paclitaxel

Shanghai Haihe Biopharma Co., Ltd. announced that its oral paclitaxel solution (brand name: Bairuisu; R&D code: RMX3001/DHP107), co-developed with South Korea’s Dae Hwa Pharmaceutical, has been approved by China’s National Medical Products Administration (NMPA) for a new indication: recurrent or metastatic HER2-negative breast cancer. The product was first approved in September 2024 for advanced gastric cancer patients whose disease progressed during or after first-line fluoropyrimidine-based therapy. 3SBio Inc. (01530.HK) holds the exclusive commercialization rights to the product in Chinese mainland and Hong Kong. In September 2017, Haihe in-licensed the rights to develop, manufacture and sell the product in Chinese mainland, Taiwan, Hong Kong and Thailand from Dae Hwa Pharmaceutical. Paclitaxel is one of the most widely used chemotherapy drugs, with substantial market demand. Until now, all paclitaxel products marketed in China were intravenous formulations that had to be prepared in hospital and given by infusion, requiring frequent hospital visits and ...
- Source: drugdu
- 196
- October 19, 2026
Beijing Fuyuan Pharmaceuticals aims to become the first generic version of a hypertension drug.

Recently, the CDE (Center for Drug Evaluation) website showed that Beijing Fuyuan Pharmaceutical’s esculenta potassium chlorthalidone tablets have had their clinical trial application accepted as a generic Class 3 product. Currently, no company has received approval for marketing or has submitted a production application for esculenta potassium chlorthalidone tablets under review. Mesartan potassium chlorthalidone tablets are a combination antihypertensive drug. Mesartan potassium belongs to the sartan (ARB) class of antihypertensive drugs, which dilates blood vessels and lowers blood pressure by blocking angiotensin receptors. Its antihypertensive effect is relatively strong among drugs of the same class. Chlorthalidone belongs to the thiazide diuretic class, which helps lower blood pressure by promoting sodium and water excretion and reducing blood volume. In recent years, the sales volume of hypertension medications (chemical and biological) has exceeded 60 billion yuan in all six major markets across China’s three major terminals (see the end of this article ...
- Source: drugdu
- 111
- October 19, 2026
The first generic version of Ponatinib from Yuandong Bio has been approved for marketing

On October 15, 2026, according to the official website of the National Medical Products Administration (NMPA ) of China, Ponatinib tablets, submitted by Chengdu ShuoDe Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yuandong Bio, were approved for marketing. Public information indicates that this drug is derived from traditional Chinese medicine preparations from medical institutions. Ponatinib tablets are a third-generation BCR-ABL tyrosine kinase inhibitor for leukemia, suitable for patients with chronic myeloid leukemia, acute lymphoblastic leukemia, and other conditions . Chronic myeloid leukemia (CML) is a malignant tumor affecting the blood and bone marrow, accounting for approximately 15% to 20% of adult leukemia cases. According to data released in the “2021 China Chronic Myeloid Leukemia Patient Report White Paper,” 20.2% of the 2,533 patients surveyed were intolerant to drug treatment. Mutations in the BCR-ABL kinase domain are one of the important mechanisms leading to resistance to tyrosine kinase inhibitor (TKI) therapy, ...
- Source: drugdu
- 148
- October 19, 2026
Clinical trial application for DR30206 for injection approved

Huadong Medicine, according to the announcement, the holding subsidiary, Zhejiang Daer Biotechnology Co., Ltd., recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA). The clinical trial application for DR30206 for injection submitted by Daer Biotechnology has been approved. The indication is: This product is intended as consolidation therapy for patients with locally advanced/unresectable (stage III) non-small cell lung cancer who have not progressed after concurrent/sequential chemoradiotherapy. Source: https://finance.eastmoney.com/a/202610163898618389.html
- Source: drugdu
- 131
- October 19, 2026
Warrant Pharmaceuticals’ active pharmaceutical ingredients, terbutaline sulfate and indocyanine green, have been approved for marketing

Recently, Warrant Pharmaceuticals(688799) Its wholly-owned subsidiary, Hunan Huana Pharmaceutical Chiral Drug Co., Ltd., successively received the ” Chemical Raw Material ” certificates for terbutaline sulfate and indocyanine green issued by the National Medical Products Administration.The drug marketing application approval notice, along with the formulation, received an “A” rating in the joint review and approval process, indicating that it meets the relevant national drug review technical standards and has been approved for use in domestic formulations. According to reports, terbutaline sulfate is the raw material for preparations such as terbutaline sulfate nebulized inhalation solution.Terbutaline sulfate nebulized inhalation solution is mainly used to relieve bronchospasm associated with bronchial asthma, chronic bronchitis, emphysema, and other lung diseases. Indocyanine green is the active pharmaceutical ingredient (API) for products such as injectable indocyanine green . Injectable indocyanine green, often referred to as “GPS on a knife’s edge,” is primarily used to diagnose various liver diseases, ...
- Source: drugdu
- 122
- October 19, 2026
Vir Biotechnology Enters Multi-Program Collaboration with Gilead Sciences to Develop Novel PRO-XTEN® Dual-masked T-cell Engagers for Solid Tumors

On October 14, 2026, Vir Biotechnology, Inc. (Nasdaq: VIR) announced a collaboration and license agreement with Gilead to discover and engineer three novel PRO-XTEN® dual-masked T-cell engager (TCE) development candidates targeting selected solid tumor-associated antigens. Gilead will have an exclusive license to develop and commercialize the novel TCEs. The collaboration combines Vir Biotechnology’s T-cell engager discovery, AI-enabled protein engineering and clinically-validated PRO-XTEN® masking technology with Gilead’s oncology development and commercialization expertise. This is the Company’s second collaboration building on the universal PRO-XTEN® masking technology. Through this collaboration, Vir Biotechnology will apply its deep expertise in TCE discovery and protein engineering, its proprietary dAIsY™ (data AI structure and antibodY) platform for rapid, multiparameter optimization of high-quality TCEs and the universal PRO-XTEN® masking technology to develop next-generation TCEs, each with potent anti-tumor activity and a wide therapeutic index across solid tumor targets addressing areas of high unmet need. “We believe TCEs have ...
- Source: drugdu
- 166
- October 16, 2026
Subsidiary’s YKYY036 Injection Receives Clinical Trial Approval from NMPA and FDA

People’s Finance News, October 13th – Yuekang PharmaceuticalOn October 13, (688658) announced that its subsidiaries, Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd. and Hangzhou Tianlong Pharmaceutical Co., Ltd. of Yuekang Pharmaceutical Group, recently received approval notices from the National Medical Products Administration (NMPA) for the use of YKYY036 injection for obese or overweight patients. Simultaneously, Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd. recently received a letter from the U.S. Food and Drug Administration (FDA) approving its application for clinical trials of YKYY036 injection for overweight or obese patients. Source: https://finance.eastmoney.com/a/202610133894283434.html
- Source: drugdu
- 126
- October 16, 2026

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.