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 ...
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 ...
According to the Medicine Intelligence Data Investment Pattern Database, surgical equipment company Nuomei Xinchuang Medical Technology (Shanghai) Co., Ltd. (hereinafter referred to as Nuomei Xinchuang) recently announced that it has successfully completed a new round of strategic financing, with a total financing amount of over 300 million yuan. This round of financing is led by Qiming Venture Capital and co invested by Sunshine Ronghui Capital. Star Bridge Capital serves as the exclusive financial advisor. It is reported that the funds raised in this round will provide important financial support for the market expansion and product research and development of Nuomei Xinchuang, further helping the company to continue leading the field of ear, nose, throat, and cranial spine surgical instruments. It is worth mentioning that according to the Medicine Intelligence Data Investment Pattern Database, this financing is the first financing for Novo Medical after its official name change. Its predecessor, Leno ...
On February 16, the Shenzhen Stock Exchange issued a decision to terminate the review of the initial public offering and listing of Yantai MyPlex International Biopharmaceutical Co., Ltd. (hereinafter referred to as MyPlex) on the Growth Enterprise Market. Previously, MyPlex’s IPO application was accepted on September 28, 2022, and passed the meeting on June 16, 2023, but the company finally chose to withdraw its application due to failure to submit registration materials within the prescribed time. According to the information, MyPlex was established in 2013 and is a CDMO (contracted research and development and production of pharmaceuticals) company focusing on the field of biopharmaceuticals, focusing on providing CDMO services for monoclonal antibodies, bispecific antibodies, polyspecific antibodies, fusion proteins, antibody-drug conjugates, recombinant vaccines, recombinant proteins and other biopharmaceuticals. The reporter of “Daily Economic News” noticed that MyBio was found to have major errors in its application materials during the first round ...
On February 17, Innovent Biologics announced that its PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 was granted Fast Track Qualification (FTD) by the US FDA, with the proposed indication being locally advanced or metastatic squamous non-small cell lung cancer that has progressed after anti-PD-(L)1 immune checkpoint inhibitors and platinum-containing chemotherapy. This is the second time that IBI363 has been granted FDA Fast Track Qualification after melanoma. According to the data, IBI363 is the world’s first PD-1/IL-2 bispecific fusion protein independently developed by Innovent Biologics, which has the functions of blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. IBI363 has shown positive efficacy and safety signals in a variety of advanced solid tumors. Innovent Biologics is currently conducting Phase 1/2 clinical studies of IBI363 in China and the United States. https://finance.eastmoney.com/a/202502183321598760.html
On February 17, AI medical concept stocks continued to be hot in the capital market. Meinian Health has 5 boards in 7 days, Anping has 20CM for two consecutive days, Saili Medical has 5 boards in 10 days, Jiahe Meikang, Xin Ganjiang, Sichuang Yihui, and Chaoyan shares have risen by more than 10%. Some popular concept stocks have also successively issued announcements on abnormal stock trading fluctuations. For example, Meinian Health announced on February 16 that the company’s current business situation is normal, and there has been no major changes in the internal and external business environment. After verification, the company and the actual controller have no major matters that should be disclosed but have not been disclosed or major matters in the planning stage. Anping issued an announcement on February 17, saying that the company has recently noticed that many media reported that Huawei Technologies Co., Ltd. will build ...
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