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[Lepu Medical: Subsidiary MWN110 injection has been approved for clinical trials by the U.S. FDA] On September 28, Lepu Medical (300003.SZ) announced that the company’s controlled subsidiary Shanghai Minwei Biotech has received a notice from the U.S. FDA agreeing to conduct clinical trials of MWN110 injection. The drug is a monoclonal antibody targeting ActRIIA/B. The applied indication is overweight or obesity. It has global intellectual property rights and has been approved by CDE for clinical trials in July 2026. Non-clinical studies have shown that the drug alone can significantly reduce body fat percentage, weight and increase muscle mass, while combined use with semaglutide can inhibit muscle loss. At present, no similar drugs have been approved for marketing at home or abroad.
#clinical trial#clone#A-share announcement express09-28 18:39
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[Macron: Supports Canada and the EU moving closer to each other] September 21st, French President Macron said on the 20th that France supports the agenda of Canada and the EU moving closer to each other, and supports Canada becoming a "joint member" of the EU. On the same day, Macron met with reporters in St. Pierre, the capital of the French overseas administrative region of St. Pierre and Miquelon, and visiting Canadian Prime Minister Carney, and made the above statement. Macron said that this is the first official visit by a Canadian prime minister to Saint-Pierre and Miquelon, and that the two countries will strengthen cooperation in areas such as fisheries, security and energy. Carney said Canada and Europe will build a future-oriented alliance to enhance "collective resilience."
#clone#Global market intelligence09-21 04:44
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[Shanghai RAAS: SR604 Injection Enters Phase III Clinical Trial] On September 16, Shanghai RAAS (002252.SZ) announced that the company’s product under development, “SR604 Injection,” recently announced the registration information for the Phase III clinical trial of “Preventive Treatment of Bleeding Episodes in Hemophilia A/B Patients” on the Drug Clinical Trial Registration and Information Disclosure Platform of the State Food and Drug Administration. SR604 injection is a humanized monoclonal antibody preparation that binds to human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. The company is conducting a phase III confirmatory clinical study on the indications for the prevention and treatment of bleeding episodes in patients with hemophilia A/B. It plans to conduct a multiple-dose trial of 0.4 mg/kg once every 4 weeks. If this variety is successfully developed, it is expected to significantly improve the medication experience of hemophilia A/B patients. As of the disclosure date of this announcement, there is no product with the same target as this drug on the market globally.
#clinical trial#clone#A-share announcement express09-16 19:54
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[Hengrui Pharmaceuticals: Subsidiary's raciximab for injection has been approved for clinical trials] On September 15th, Hengrui Pharmaceuticals (600276.SH) announced that the company's subsidiary Guangdong Hengrui Pharmaceutical has received the approval from the State Food and Drug Administration to issue a "Drug Clinical Trial Approval Notice" for raciximab for injection, and agreed to conduct a Phase III clinical trial for adult patients with intracranial atherosclerotic stenosis to reduce the risk of recurrence of stroke. The drug is an anti-PCSK9 monoclonal antibody independently developed by the company. It has been approved for marketing in China in 2025. The cumulative investment in research and development of related projects is approximately 422 million yuan.
#clinical trial#clone#A-share announcement express09-15 16:35
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[Canada seeks to establish a unique alliance with the EU] On September 13, local time, Canadian Prime Minister Carney said that Canada is seeking to establish a "unique alliance" with the EU, but does not intend to become an EU member state. Carney said that day that Canada would begin negotiations with the EU on establishing a "unique alliance." It is reported that Carney will visit France and the United Kingdom. He will address the European Parliament in Strasbourg and attend EU President Ursula von der Leyen's State of the Union speech. Carney will also meet with French President Emmanuel Macron in the French island of Saint Pierre and Miquelon. Previously, there were reports that Canada was exploring the possibility of becoming an "associate member" of the European Union. (CCTV International News)
#clone09-14 10:05
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[The first domestically produced long-acting respiratory syncytial virus preventive monoclonal antibody is approved] On September 4, Simcere Pharmaceuticals announced that the domestic Class 1 bio-innovative drug Culevibizumab Injection (trade name: Inmulac), a strategic collaboration between it and Ruiyang (Shandong) Biopharmaceutical Co., Ltd., was approved for marketing by the National Medical Products Administration, becoming China’s first domestically produced long-acting preventive monoclonal antibody against respiratory syncytial virus (RSV) approved for marketing.
#biopharmaceutical#clone#Virus#medicine#Pharmaceutical business09-04 19:43
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[Tylenumab: Riteviribumab injection has been approved for marketing by the State Food and Drug Administration] On September 3, Tylenumab (688806.SH) announced that the company received a notice from the State Food and Drug Administration to approve the independently developed Class 1 innovative drug Riteviribumab injection for children through the priority review and approval process. This product is suitable for preventing lower respiratory tract infections caused by RSV in newborns and infants who are about to enter or are born in the first respiratory syncytial virus epidemic season. Key Phase III clinical trials showed that within 150 days after administration, the protective efficacy against RSV lower respiratory tract infections requiring medical treatment and hospitalization resulted in 71.3% and 71.7%, and the protective efficacy against severe RSV LRT increased to 93.9% and 90.1%. This product is the world's first RSV monoclonal antibody with clinical protection data of up to nine months after one injection. This approval marks the successful launch of the company’s second independently developed fully human monoclonal antibody innovative drug.
#clinical trial#clone#Virus#A-share announcement express09-03 16:54