On July 17, Gaush Medical (02407) issued an announcement that the “corneal contact cap” of its subsidiary ShenzhenGaush Technology Co., Ltd. has been approved by the Guangdong Provincial Food and Drug Administration for medical devices.Registration certificate (Registration certificate number: Guangdong Medical Device Registration No. 20252161020). This product is used to cover the corneal microscope objective lens of the confocal ophthalmic laser diagnostic equipment when the patient’s cornea is tomographically scanned, which can effectively avoid cross infection and ensure the safety of the diagnosis and treatment process. The corneal contact cap consists of two parts: the corneal contact plane and the cone cover. It is made of high-quality medical-grade optical plastic and is formed by precision injection molding. The product has a flat and smooth surface, no scratches or impurities, and excellent light transmission performance, which can minimize light loss and refraction interference. In addition, the structural design of the product fits ...
July 17, Xinhua Medical(600587) announced that the company has recently obtained two medical device certificates issued by the Shandong Provincial Drug Administration.The registration certificates are for anesthesia machines, ventilator circuit disinfectors and electric beds. The registration certificate number of the anesthesia machine ventilator circuit disinfection machine is Lu Xie Zhu Zhun 20252110405, the approval date is July 4, 2025, and it is valid until July 3, 2030. The registration certificate number of the electric bed is Lu Xie Zhu Zhun 20252150409, the approval date is July 7, 2025, and it is valid until July 6, 2030. The launch of these two products will enrich the company’s product line. The anesthesia machine ventilator circuit disinfection machine provides a convenient and safe disinfection method for medical units, while the electric bed meets the different body position requirements of patients during treatment and improves nursing efficiency. The announcement pointed out that the launch ...
On the evening of July 17, Tiantan BiotechnologyDisclose announcements on the progress of clinical trials of drugs of affiliated companies. The announcement shows that the company’s subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd.’s marketed product “Intravenous Human Immunoglobulin (pH4)” (10%, 50ml) has completed clinical ethics review, pre-clinical preparations and other work for the new indication of chronic inflammatory demyelinating polyradiculoneuropathy, and has officially started Phase III clinical trials recently. This newly added indication is the first intravenous human immunoglobulin product in China to be approved for clinical research on the indication of chronic inflammatory demyelinating polyradiculoneuropathy. The main procedures that need to be fulfilled for the above-mentioned product to be approved for the new indication include: completing Phase III clinical trials, submitting an application for a license for the new indication, and obtaining approval for the new indication after passing the review of the Drug Evaluation Center of the National Medical ...
July 17, ST Huluwa(605199) issued an announcement that it recently received the “Notice of Approval of Drug Supplementary Application” for Ceftriaxone Sodium for Injection approved and issued by the National Drug Administration. The drug has successfully passed the generic drug quality and efficacy consistency evaluation. The specifications of the drug are 1.0g and 2.0g, the manufacturer is the company, and the original drug approval number is National Medicine Standard H20043257. The approval conclusion of this time confirms that this product meets the consistency evaluation standards according to the provisions of relevant laws and regulations, and agrees to change the drug quality standards and packaging materials that directly contact the drug.and container. As of the date of disclosure of the announcement, in addition to the company, more than three manufacturers have passed the consistency evaluation of the drug. The company has invested a total of RMB 3.61 million in research and ...
Sciwind Biopharma has registered a new clinical trial on the Drug Clinical Trial Registration and Information Disclosure Platform: a multicenter, randomized, open-label, switch treatment phase II study (SLIMMER-UP-SWITCH) on the efficacy and safety of XW003 injection versus semaglutide injection in obese patients. If the Phase II results are positive, it will further verify the clinical advantages of its world-first cAMP-biased GLP-1 mechanism and accelerate its impact on the 100 billion weight loss market. https://bydrug.pharmcube.com/news/detail/63af1637f55a1e3fc18e6a3e70bc5dd6
Baili Tianheng announced that it recently received the “Notice of Approval for Drug Clinical Trial” officially approved and issued by the National Medical Products Administration (NMPA). The company’s independently developed innovative biological drug Iza-bren (EGFR×HER3 dual-antibody ADC) combination drug Phase II clinical trial was approved for use in a clinical trial combined with lenvatinib ± pembrolizumab to treat advanced renal cancer. This therapy combines lenvatinib and pembrolizumab, which is expected to enhance the anti-tumor effect through multi-target synergy and fill the unmet needs in the field of renal cancer treatment. If the clinical trial goes smoothly, it will enhance the company’s competitiveness in the ADC track. https://m.cnstock.com/commonDetail/469101
The CDE official website shows that BeiGene and Amgen’s application for taratumumab injection has been accepted for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have failed at least 2 lines of treatment (including platinum-containing chemotherapy). This indication has been included in the priority review. Globally, only one DLL3/CD3 dual antibody, taratumumab, has been approved for marketing. In addition, there are 4 other products that have entered the clinical stage, with the highest progress being clinical phase II. In terms of clinical progress, taratumumab has a first-mover advantage. https://finance.sina.com.cn/roll/2025-07-17/doc-infftyiu0311325.shtml
Bio-Thera announced that the biologics license application (BLA) for BAT2506 (golimumab injection) has been accepted by the U.S. Food and Drug Administration (hereinafter referred to as FDA). The drug is a golimumab biosimilar developed by Bio-Thera, and its original drug is Simponi of Johnson & Johnson in the United States. According to Johnson & Johnson’s 2024 annual report, Simponi’s global sales last year were US$2.19 billion. BAT2506’s application for listing has been accepted by regulatory agencies in China, the United States, Europe and Brazil. However, given the lucrativeness of the U.S. pharmaceutical market, if BAT2506 is approved for listing in the United States, the commercial returns of the drug are expected to increase significantly. https://www.nbd.com.cn/articles/2025-07-16/3947861.html
Recently, according to Fierce Biotech, BD Medical officially announced the appointment of Bilal Muhsin as executive vice president, and he will serve as president of the “Connected Care” department, one of the four major departments of BD Medical. The appointment will take effect immediately from the date of official announcement. It is reported that Bilal Muhsin is a veteran of Masimo, who has been in the company for 25 years and served as executive vice president of engineering, marketing and regulatory affairs. Founded in 1989, Masimo is a globally recognized leader in non-invasive monitoring technology, dedicated to developing and producing various leading monitoring technologies and equipment in the medical industry, including meters, sensors, pulse oximeters, patient monitors and automation equipment. After joining BD Medical, Bilal Mushin will lead strategic development, report to Tom Polen, chairman, CEO and president of BD, and participate in the decision-making of BD’s global executive leadership ...
On July 15, Hengrui Medicine disclosed the positive top-line results of its GLP-1/GIP dual receptor agonist HRS9531 in China’s Phase III weight loss study. The average weight loss in the 6mg dose group was 19.2% in 48 weeks, and it did not reach the plateau. At the same time, the safety is good, and Hengrui plans to submit a new drug application in the near future. Not long ago, Innovent Biologics’ GLP-1/GCG dual receptor agonist Xinermei® (Masdu peptide) was approved for marketing in China for adult weight control. Its Phase III clinical trial showed that at week 48, the average weight loss in the 6 mg group reached 14.84%. The GLP-1 products of the two major pharmaceutical companies, Innovent and Hengrui, have entered the harvest period one after another, and the domestic weight loss drug market has ushered in a new pattern. Average weight loss of 19.2% in 48 weeks ...
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