Today (February 18th), Zhuhai Beihai Biotechnology Co., Ltd. (referred to as “Beihai Biotechnology”) announced that it has reached a significant strategic cooperation with Zydus Lifesciences, granting its new drug BEIBRAY (docetaxel BH009) exclusive commercialization rights in the US market. The news pointed out that BEIZRA is the first improved new drug in China to successfully achieve authorization for export to the United States in recent years. According to the terms of the agreement, Beihai Biotechnology will be responsible for the production and supply of BEIBRAY, while Zydus Pharmaceuticals, a US subsidiary of Zydus, will be responsible for the commercialization of the product in the United States. Beihai Biotechnology will receive a down payment of $15 million (to be paid after the agreement is signed) and $10 million (to be paid after the first product delivery), as well as multiple sales milestone payments and high double-digit profit sharing. According to a ...
On February 17, Watson Pharmaceuticals announced that the company recently received the “Drug Re-registration Approval Notice” for the company’s product Orlistat Capsules approved and issued by the Chongqing Municipal Drug Administration. The drug approval number of Orlistat Capsules is valid until January 22, 2030. The product was originally a cooperative product of the company. At the end of 2021, the company reached a further agreement with its partners to sell and operate Orlistat Capsules under its own brand “Quchang”. At present, this variety has little impact on the company’s operating income and profits. It will not have a significant impact on the company’s operating performance in the short term. https://finance.eastmoney.com/a/202502173321214653.html
Baili Tianheng (688506) announced on the evening of February 18 that the company recently received the “Drug Clinical Trial Approval Notice” officially approved and issued by the National Medical Products Administration (NMPA), and the Phase II/III clinical trial of the company’s independently developed innovative biological drug BL-M07D1 (HER2-ADC) for injection was approved. As of the disclosure date of this announcement, in addition to the newly approved clinical trial, BL-M07D1 is being evaluated as a single drug or in combination in 10 Phase I/II/III clinical trials in China and the United States. The various clinical studies include patients with various HER2-expressing/mutated solid tumors (including non-small cell lung cancer, breast cancer, urothelial carcinoma, gynecological tumors and digestive tract tumors). https://finance.eastmoney.com/a/202502183322435142.html
Reporters learned from Merck that Beijing’s male HPV vaccination work has been fully launched. Related studies have confirmed that HPV vaccines can provide lasting protection and are safe. Several new indications of the quadrivalent human papillomavirus vaccine (brewer’s yeast) have been approved for marketing by the National Medical Products Administration and are suitable for males aged 9-26. This is the first and currently the only HPV vaccine approved for males in China, filling an important gap in the field of male HPV prevention. Merck said that at present, the supply of vaccines in Beijing is stable, and the official platform for male HPV vaccination appointments has been officially opened. Citizens only need to pull down the Jingtong applet on WeChat, find vaccination in the “appointment registration” on the main page, enter to make a vaccine appointment, or download the Capital Vaccine Service app to make the same appointment, and then ...
Gan&Lee Pharmaceuticals (603087) announced that the company’s GZR4 insulin weekly formulation has successfully completed the first subject dose in Phase III clinical trial in China. GZR4 is an ultra-long-acting insulin injected subcutaneously once a week, suitable for patients with diabetes. Compared with the existing long-acting basal insulin on the market, GZR4 has a longer half-life and lower dosing frequency, can provide more stable blood drug concentration and efficacy, and reduce the risk of hypoglycemia. As of September 30, 2024, the company has invested a total of RMB 153 million in research and development expenses in the GZR4 project. The project was approved for clinical trials by the China National Medical Products Administration in July 2022, and the first subject dosed in Phase II clinical trials in September 2023. The completion of the first dose in Phase III clinical trials marks another important progress in the GZR4 project, reflecting the company’s ...
Organiser:Informa Markets Time:October 20th – 23th, 2025 Address:King Abdullah Rd, King Abdullah Dt., Riyadh 11564, Saudi Arabia Exhibition hall:Riyadh International Convention & Exhibition Center Product range: Medical Devices & Equipment: Medical electronic equipment, medical ultrasound equipment, medical X-ray equipment, clinical laboratory analytical instruments, dental equipment & materials, operating room, emergency room, and consulting room equipment & appliances, disposable medical supplies, medical dressings & hygienic materials, various surgical instruments, medical healthcare equipment & appliances, traditional Chinese medicine instruments & rehabilitation equipment, hemodialysis equipment, anesthesia & respiratory equipment, etc. Household Healthcare Products & Small Healthcare Devices: Household healthcare products, small household diagnostic, monitoring, and treatment instruments, rehabilitation, physiotherapy instruments & appliances, electronic medical instruments, sports medicine products, etc. Laboratory Instruments & Equipment: Laboratory instruments & equipment, laboratory furniture, laboratory automation & accessories, optical instruments & equipment, medical laboratory analysis & diagnostic instruments, biopharmaceutical instruments, cellular biology instruments, biotechnology equipment, etc. Medical ...
Drugdu.com expert’s response: The necessity of FDA (U.S. Food and Drug Administration) and CE (Conformité Européenne) certifications for pharmaceuticals and medical devices is primarily based on the following reasons: I. Importance of FDA Certification Ensuring Product Safety and Effectiveness: The FDA conducts rigorous reviews and testing processes for pharmaceuticals and medical devices to ensure their safety and effectiveness. This is a crucial step in protecting consumer health. Enhancing Public Trust: Products that have obtained FDA certification are generally regarded as symbols of quality and safety, which helps to enhance public trust in these products. Market Access Requirements: FDA certification is a necessary condition for selling pharmaceuticals and medical devices in the U.S. market. Products without certification cannot enter the U.S. market. Facilitating International Trade: Many countries and regions refer to FDA certification standards when importing pharmaceuticals and medical devices. Obtaining FDA certification helps products gain broader recognition in the international ...
Recently, the biopharmaceutical industry in the Guangdong Hong Kong Macao Greater Bay Area has achieved a good start. The official WeChat official account of Guangdong Provincial Food and Drug Administration announced yesterday that the State Food and Drug Administration has recently approved the listing of three types of Class 1 innovative drugs in the region, namely, Stadumumab injection, Racacizumab for injection, and Natltamivir Phosphate Capsules, which marks that the Great Bay Area has taken a solid step in the field of biomedical innovation, and the number of new drugs launched in the world has reached a record high. The approval of innovative drugs demonstrates the initial results of the Greater Bay Area’s sustained investment in the field of biomedicine in recent years. It is reported that the world’s first ultra long acting PCSK9 monoclonal antibody developed by Guangdong Hengrui Pharmaceutical Co., Ltd. is used to treat hypercholesterolemia, breaking through the ...
The competition in the field of atropine sulfate, known as the “miracle drug for myopia”, is becoming increasingly fierce. After Zhaoke Ophthalmology (06622. HK), the drug marketing authorization application for HR19034 eye drops under Hengrui Pharmaceutical (600276. SH) has been accepted by the National Medical Products Administration, and the exclusive situation of Xingqi Eye Medicine (300573. SZ) may be broken. In addition, several pharmaceutical companies have entered phase 3 clinical trials for atropine sulfate eye drops suitable for adolescent myopia. This evening, Hengrui Pharmaceutical announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has received a “Notice of Acceptance” issued by the National Medical Products Administration. The company’s application for marketing authorization for HR19034 eye drops has been accepted by the National Medical Products Administration. Hengrui Medicine stated in the announcement that HR19034 eye drops are a single dose eye drop developed by the company using B/F/S three in one ...
Recently, ForSight Robotics, a pioneer in ophthalmic surgical robotics, announced that Dr. Fred Moll, co-founder of Intuitive Surgical, has joined its board of directors. Intuitive Surgical is the company behind the most successful surgical robot system in history – the da Vinci Surgical System. Dr. Fred Moll, as a co-founder, is known as the “father of surgical robots”. His joining ForSight Robotics is his first time serving as a consultant for a surgical robot company in the field of ophthalmology. 01. The world’s first cataract and panocular surgery robot ForSight Robotics is headquartered in Israel and has developed the ORYOMTM platform (Hebrew for “daylight”), which claims to be the world’s first robotic surgical platform for cataracts and panocular diseases. It will utilize AI based algorithms, computer vision, and micro mechanical technology. At the 2024 American Society of Cataract and Refractive Surgery Annual Meeting (ASCRS2024), renowned cataract surgeon and former president ...
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