On March 18, Buchang Pharmaceutical announced that the company received the “Notice of Approval of Supplementary Drug Application” for Angong Niuhuang Wan approved and issued by the State Drug Administration, agreeing that the holder of the marketing authorization for Angong Niuhuang Wan has been changed from Liaoning Hancaotang to Buchang Pharmaceutical. This change will not have a significant impact on the company’s current production and operation, but it will help expand the company’s business, enrich its product line, and enhance its market competitiveness. The specific sales of drugs in the future may be affected by factors such as industry policies and changes in the market environment, and there is uncertainty. 21 Comments: In April 2023, Buchang Pharmaceutical announced that it plans to acquire the drug production technology of Angong Niuhuang Wan owned by Liaoning Hancaotang for 8.4 million yuan. In recent years, the sales volume and sales of Angong Niuhuang ...
According to the website of the National Healthcare Security Administration on the 17th, the National Joint Procurement Office for Drugs issued the “Announcement on Cancelling the Qualification of Sichuan Haimeng Zhisen Biopharmaceutical Co., Ltd. for Phloroglucinol Injection and Listing the Company and the Product Manufacturer Taiji Group Sichuan Taiji Pharmaceutical Co., Ltd. on the Violation List” on the 17th. The announcement shows that the phloroglucinol injection produced by Sichuan Haimeng Zhisen Biopharmaceutical Co., Ltd. on behalf of Taiji Group Sichuan Taiji Pharmaceutical Co., Ltd. is the selected drug in the tenth batch of national centralized drug procurement, which has not yet been implemented. According to the supervision and inspection notice issued by the Sichuan Provincial Drug Administration on March 17, 2025, the holder Sichuan Haimeng Zhisen Biopharmaceutical Co., Ltd. failed to effectively monitor the production process of the entrusted production enterprise, and the entrusted production enterprise Taiji Group Sichuan Taiji ...
The traditional view is that cancer originates from the accumulation of somatic mutations, but many studies in recent years have found that epigenetic abnormalities are an important factor leading to tumorigenesis. At present, epigenetic changes can be used as biomarkers for cancer and can even be targeted by cancer treatment. As an important role in the epigenetic modification process, EZH2 has multiple targeted drugs approved for marketing and entered the late clinical stage, and has become a highly concerned anti-tumor target. Close connection between EZH2 gene and cancer The Zeste enhancer homolog 2 (EZH2) gene is one of the important members of the PcG family of epigenetic regulatory factors, and is also the catalytic subunit of Polycomb Repressive Complex 2 (PRC2). It plays a vital role in the H3 methylation pathway and plays an important role in the epigenetic modification process. Studies have found that EZH2 expression is elevated in ...
Organiser: Ecommerce Gateway Pakistan (Pvt.) Ltd Time: October 23 – 25, 2025 Address: University Rd, Gulshan-e-Iqbal, Karachi, Pakistan Exhibition hall: Karachi Expo Center Product range: Medical Supplies: Medical diagnostic equipment and supplies, pharmaceutical products, electronic medical equipment and instruments, emergency rescue equipment, medical reagent equipment, disposable medical devices Hospital Supplies: Catheters, interventional materials, surgical hygiene products, disposable medical consumables, surgical instruments, medical clothing and bedding, hospital furniture, emergency equipment, maternal and child care equipment, sterilization equipment, orthopedic prosthetics, air filtration devices, blood pressure diagnostic instruments for medical staff, heart rate monitors, ultrasound equipment, X-ray diagnostic equipment, urological and transplantation services, dialysis machines, physiotherapy equipment Laboratory Equipment: Laboratory instruments and equipment, optical instruments and equipment, image analysis and processing systems, testing instruments and devices, quality detection equipment, laboratory renovation and upgrading technologies, consumables, and related software, etc. Pharmaceuticals & Healthcare: Ophthalmic pharmaceuticals, orthopedic medications, traditional Chinese medicines, western medicines, traditional Chinese medicine health products, ...
CSPC Pharmaceutical Group announced that JSKN003 (an antibody-drug conjugate targeting HER2 dual epitopes) developed by its subsidiary Shanghai Jinman Biotechnology Co., Ltd. and Jiangsu Alphamab Biopharmaceuticals Co., Ltd. has been granted Breakthrough Therapy Designation by the China National Medical Products Administration. The proposed indication is monotherapy for the treatment of all patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer (“the indication”). The annual incidence of ovarian cancer ranks third among female reproductive system tumors in China, and the mortality rate ranks first among female reproductive tract malignancies. About 70% of patients are in the advanced stage when they seek medical treatment. Tumor cell reduction surgery combined with postoperative platinum-containing chemotherapy is the current main treatment method, but almost all patients eventually develop platinum resistance. For patients with platinum resistance, non-platinum single-agent chemotherapy is the main treatment option recommended by domestic and international guidelines, but ...
On March 17, Shapuaisi (603168) issued an announcement that the company recently obtained the “Drug Registration Certificate” for tafluprost eye drops approved and issued by the State Drug Administration. The drug is an ophthalmic preparation with a specification of 0.0015% (0.3ml: 4.5μg) and is registered as Class 4 chemical drugs. The company’s cumulative R&D investment in the drug is approximately RMB 6.46 million. Obtaining a drug registration certificate will help enrich the company’s product categories and optimize product layout. However, the future production and sales of the drug will still face many uncertain factors such as changes in pharmaceutical industry policies, bidding and procurement, and market environment, so there is uncertainty about the impact on the company’s performance. https://finance.eastmoney.com/a/202503173347698684.html
On March 17, Huiyu Pharmaceuticals issued an announcement that the company recently received the “Drug Registration Certificate” for Melphalan Hydrochloride for Injection approved and issued by the State Drug Administration. The registration classification of this drug is Class 4 chemical drugs, the specification is 50mg, and the drug validity period is 18 months. The registration certificate number is 2025S00720, and the drug approval number is National Medicine Standard H20253620. Melphalan is suitable for high-dose pretreatment and palliative treatment of patients with multiple myeloma. According to Minnet data, the sales of melphalan hydrochloride for injection in terminal hospitals in urban public hospitals in China in the first half of 2024 were approximately 86 million yuan. The company is the second company deemed to have passed the consistency evaluation of generic drug quality and efficacy. It is expected that drugs that have passed the consistency evaluation will receive greater support in areas ...
Recently, according to the official website of CDE, Hydroxocobalamin Injection of China Resources Double Crane and Fitusiran Injection of Genzyme Corporation were included in the pilot project of the “Patient-centered Rare Disease Drug R&D Pilot Work Plan (“Care Plan”)”. 1. Hydroxocobalamin Injection Variety name: Hydroxocobalamin injection Applicant: China Resources Double Crane Pharmaceutical Co., Ltd. Indications: This drug is suitable for the treatment of metabolic disorders in children with methylmalonic acidemia (MMA) with or without homocystinemia. Application stage: Phase A – R&D project establishment stage. Key points: During the R&D project establishment stage, detailed patient survey questionnaires will be collected to provide a basis for subsequent drug development, dosage forms, etc.; at the same time, the data on the natural history of MMA disease will be further enriched. 2. Fitusiran Injection Product name: Fitusiran injection Applicant: Genzyme Corporation Indications: This product is indicated as a routine preventive treatment for adult patients ...
Drugdu.com expert’s response: The registration of Class II and Class III medical devices is primarily based on the following reasons: I. Legal and Regulatory Requirements The “Regulations on the Supervision and Administration of Medical Devices” clearly stipulate that Class II and Class III medical devices must undergo registration management, and medical devices that have not undergone registration are prohibited from being sold and used in the market. This is a fundamental principle for the standardized operation of the medical device industry, and enterprises must comply with it to ensure legal operations. II. Risk Level Management Medical devices are classified into three categories based on their risk levels, with Class II and Class III belonging to medium and high-risk levels, respectively. Class II medical devices, such as thermometers, sphygmomanometers, and electrocardiographs, may lead to misdiagnosis, mistreatment, or cause certain harm to patients if there are issues with their quality or safety. ...
Recently, the injectable hydroxyapatite microsphere facial filler (registration certificate number: National Medical Device Approval No. 20253130390) applied by Shanghai Moyang Biotechnology Co., Ltd. has been approved for market by the National Medical Products Administration. At the same time, Merz North America Inc., a subsidiary of Merz North America Inc., which is represented by Merz Business Management Consulting (Shanghai) Co., Ltd., also obtained market approval on March 10, 2025 for the injectable hydroxyapatite microsphere facial filler produced by Merz North America Inc. (Registration number: National Medical Device Injection No. 20253130124). 1st domestically produced product Shanghai Moyang Biotechnology Co., Ltd.’s injectable hydroxyapatite calcium phosphate microsphere facial filler is the first officially approved hydroxyapatite based facial injection filler material in China, suitable for subcutaneous injection in the nasolabial folds to correct moderate to severe nasolabial folds. According to publicly available information, the main components of this product are: calcium hydroxyphosphate, sodium carboxymethyl cellulose, ...
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