Tasly Bioharma (hereinafter referred to as the “Company”) has received a Notice of Approval for Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the “SDA”) for the project of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as the “B2278 Injection”), agreeing to carry out the project of Coronary Artery Bypass Grafting (Coronary Artery Bypass Grafting). The Company has received a Notice of Approval for Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as “B2278 Injection”) from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing to carry out a clinical trial on chronic heart failure caused by chronic ischemic cardiomyopathy with indications of Coronary artery bypass graft (“CABG”). The relevant information is announced as follows: I. Basic information of the drug Drug name: human umbilical cord mesenchymal stem cell injection Dosage form: Injection Specification: 5×107 cells/1 ...
Novartis is paying Voyager Therapeutics $100 million up front to collaborate on gene therapies for Huntington’s disease and spinal muscular atrophy. The deal builds on a relationship the companies started in 2022. By FRANK VINLUAN Novartis is committing $100 million to Voyager Therapeutics to see if the biotech’s technology can lead to new gene therapies for Huntington’s disease and spinal muscular atrophy. According to deal terms announced Tuesday, the sum is an upfront payment that includes a $20 million equity investment in Voyager. Milestone payments could bring the Lexington, Massachusetts-based biotech up to $1.2 billion more. If the partnership leads to commercialized therapies, Voyager would also receive royalties from sales. Gene therapies reach their bodily destinations carried aboard an engineered virus. The therapy’s genetic cargo is enveloped by a protein shell called a capsid. Voyager’s TRACER technology platform discovers capsids that can target particular types of tissue. In addition to ...
ROCKVILLE, U.S. and SUZHOU, China, Jan 2, 2024 — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed in a Phase 3 clinical trial (GLORY-2) of higher dose 9 mg mazdutide (Innovent R&D Code: IBI362) , a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with obesity. This is also the fourth large-scale phase 3 clinical study of mazdutide.GLORY-2 plans to enroll 450 subjects and randomize to receive mazdutide 9 mg treatment or placebo. The primary endpoints include the percentage change in body weight from baseline to week 60 and the proportion of subjects with 5% or more body weight loss from baseline at week 60.A Phase 2 study conducted in Chinese people with obesity ...
Sanofi announced that its rosuvastatin and ezetimibe tablets (I) (Yipian Lida®) have been approved by the National Medical Products Administration (NMPA) of China for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) patients. As the first approved and marketed combination formulation of rosuvastatin and ezetimibe in China, Yipian Lida® marks the beginning of a new era in potent combination lipid-lowering therapy. A single dose achieves a greater than 50% reduction in low-density lipoprotein cholesterol (LDL-C), effectively and continuously lowering LDL-C to target levels, supporting ‘Dual Standards’ in lipid management, and providing a new and powerful option for patients with lipid abnormalities. Academician Ge Junbo from Zhongshan Hospital, affiliated with Fudan University, stated, “In the face of the increasingly serious burden of cardiovascular diseases, effective control and management of risk factors are crucial. Only by controlling LDL-C to ideal levels early can we reduce the incidence of adverse events and ...
ROCKVILLE, Md. and SUZHOU, China, Dec 20, 2023 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and Sanegene Bio USA Inc. (SanegeneBio) announce that they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Innovent also obtains an exclusive option to license in the future development, manufacturing and commercialization rights of SGB-3908. SGB-3908 is an IND-enabling stage siRNA drug developed based on SanegeneBio’s proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) platform. Under the terms of the agreement, both parties will be jointly responsible for the development of SGB-3908 to certain stage. Innovent will receive an exclusive option to pay different option exercise fees to obtain the exclusive development, manufacturing, and commercialization license of SGB-3908 in ...
Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
Time: Oct 8-10, 2024 sponsor: Informa Markets Venue:Milan International Exhibition Center City: Milan / Italy Product categories: Bulk drug: Vitamins, hormones, sulfonamides, antipyretic and analgesic drugs, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macroliones, respiratory system drugs, central nervous system drugs, and other Western medicine raw materials. Excipients and dosage forms: excipients, flux-aids, enteric-soluble materials, antioxidants, sweeteners, permeability enhancers, preservatives, disintegrators, coating materials, surfactants, sunblocks, fragrances, filter AIDS, stabilizers, lubricants, plasticizers, solvents, flavor straighteners, colorants, clarifying agents, PH regulators. Other natural extracts: Plant extract, animal extract, traditional Chinese medicine raw materials, functional food raw materials, health products raw materials, nutrition and health products raw materials, supplements, dietary fiber, beauty cosmetics raw materials, biological product reagents: antibody, nucleic acid/protein synthesis, carrier and construction, cell biological detection, animal/plant protein/antigen/polypeptide, nucleic acid analysis, library and construction, biochemistry, standard Product/reference product, ...
ROCKVILLE, U.S. and SUZHOU, China, Dec 18, 2023,— Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that results of a Phase 2 clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications. Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, stated, “As a chronic disease with complex underlying causes, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, joint diseases, sleep apnea in addition to cancers. Obesity requires increased public awareness of long-term treatment and management with effective and science-backed approaches. China has the largest obese population; however, no safe and efficacious ...
On December 16th, during the 18th Asia-Pacific Symposium on Hypertension, the National Launching Meeting of Sacubitril Valsartan Sodium Tablets (trade name: Yixintan®), which is exclusively commercialized by Fosun Pharmaceuticals and researched, developed and manufactured by Nanjing Fangshenghe Pharmaceuticals, was held grandly in Shanghai. The approved indications of Yixintan® (sacubitril valsartan sodium tablets) are for use in adult patients with chronic heart failure (NYHA class II-IV, LVEF ≤ 40%) with reduced ejection fraction, to reduce the risk of cardiovascular death and hospitalization for heart failure; and for the treatment of essential hypertension. The product is a first-line drug for the treatment of heart failure and hypertension with an innovative crystalline form with independent intellectual property rights. After the launching ceremony, a press conference on the national launching of Yixintan® was held, in which experts appeared and answered questions from the media about the current situation of cardiovascular prevention and treatment, the ...
By Tristan Manalac Pictured: Roche’s building in California Roche on Monday announced it has entered into a definitive merger agreement with Berkeley, California-based Carmot Therapeutics, a move that could place it in the thick of the lucrative and increasingly competitive weight-loss market. As per the terms of the acquisition, Roche will make an upfront payment of $2.7 billion at the transaction’s close, which the companies anticipate will occur in the first quarter of 2024, pending regulatory and anti-trust clearance. Carmot’s equity holders will also be eligible for up to $400 million in additional payments, contingent on the achievement of certain milestones. In return, Roche will gain access to Carmot’s portfolio of preclinical and clinical assets, including three GLP-1 receptor agonists, which have “best-in-class potential to treat obesity,” according to Monday’s news release. Carmot’s lead asset is CT-388, a dual agonist of both the GLP-1 and GIP receptors that is ready ...
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