Approved Clinical Trials of Humanwell Pharmaceutical Opioid Analgesics RFUS-144

       On June 29th, Humanwell Pharmaceutical Group Co., Ltd. announced that its holding subsidiary, Yichang Humanwell Pharmaceutical Co., Ltd., had developed a Class 1 new drug, RFUS-144 injection, which has been approved by the National Food and Drug Administration for clinical use in the treatment of pain and itching. RFUS-144 is a selective opioid receptor agonist, and there is currently no similar product available in China. Public data shows that in 2021, the global market sales in the pain field were $3.477 billion, with opioid receptor analgesics accounting for 66.8% of the total. (Information from GBIHealth)

Minstar Pharmaceutical's Aficamten Approved for Phase III in China for Hypertrophic Cardiomyopathy

       On June 29th, Minstar Pharmaceutical announced that the Drug Review Center of the State Drug Administration has approved the application for a Phase III clinical trial of Aficamten (CK-3773274 tablets) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in China, which is part of the global multicenter study of Aficamten, SEQUOIA-HCM. Aficamten, developed by Cytokinetics, is a potential next-generation cardiac myosin inhibitor for the treatment of hypertrophic cardiomyopathy (HCM), which was previously recognized as a breakthrough therapeutic drug in China and the U.S. In July 2020, Minstar entered into a licensing and collaboration agreement with Cytokinetics to obtain an exclusive license for the development and commercialization of Aficamten in Greater China. Aficamten reduces the number of active myosin force-producing cross-bridges per cardiac cycle, thereby inhibiting myocardial over-contraction associated with hypertrophic cardiomyopathy (HCM). Aficamten is expected to improve the treatment of oHCM, for which no therapeutic drug has been approved in China to address the underlying pathophysiology. (Information from GBIHealth)

Harbour BioMed Receives FDA IND Clearance for B7H4x4-1BB Bispecific Antibody

       On June 27, Harbour BioMed announced that the U.S. Food and Drug Administration (FDA) approved an Investigational New Drug (IND) application for a B7H4x4-1BB bispecific antibody (HBM7008), which has successfully completed the first patient in the May 2022 Phase I trial of HBM7008 in Australia, and received early June 2022 Chinese HBM7008 is a first-in-class bispecific antibody against B7H4 and 4-1BB. The bispecific antibody can engage and activate T cells via 4-1BB only in the microenvironment of B7H4-positive tumors.B7H4 is overexpressed in a variety of solid malignancies, including breast, ovarian, endometrial, and non-small cell lung cancers. With its tumor-dependent cross-linking specificity and potent immunomodulatory activity, HBM7008 has demonstrated an excellent safety profile and potent anti-tumor efficacy in preclinical studies. (Information from the official website of He-Platinum Pharmaceuticals)

Lilly's breakthrough new Aβ-targeting drug: donanemab, Alzheimer's disease clinically approved in China

       The CDE's official website announced that Lilly Company's filing of a new Aβ-targeted drug, donanemab injection, was granted an implied license for clinical trials. The drug is an anti-beta amyloid (Aβ) antibody drug intended to be developed for the treatment of early symptomatic Alzheimer's disease, including mild cognitive impairment due to Alzheimer's disease as well as mild Alzheimer's disease. donanemab is a monoclonal antibody that binds to the beta amyloid isoform N3pG. It binds to beta amyloid in the amyloid deposits in the brains of patients with Alzheimer's disease, thereby facilitating the clearance of amyloid deposits from the patient's brain. Previously Donanemab has met its primary endpoint in a Phase II clinical trial, based on which Donanemab has received Breakthrough Therapy designation from the FDA in June 2021, and Lilly has initiated the filing of a rolling marketing application for the drug with the US FDA. (Information from the CDE website)

Hengrui Medicine's SHR4640 Tablets Combined with Febuxostat Tablets Approved for Gout Patients with Hyperuricemia

       On June 16th, Hengrui Medicine announced that it has received the "Notice of Approval of Drug Clinical Trial" approved by the State Drug Administration, approving the company's SHR4640 tablets combined with febuxostat tablets to carry out clinical trials for gout patients with hyperuricemia.SHR4640 tablets is a selective small-molecule inhibitor developed by Hengrui Medicine for URAT1 (urate transporter), which is specifically expressed in the epithelium of renal tubules, and is the company's independent innovation of class 1 anti-gout drug. SHR4640 tablets are highly selective small molecule inhibitors developed by Hengrui Medicine for URAT1 (urate rotamer) specifically expressed in renal tubular epithelial cells, which is the company's independently innovated Class 1 anti-gout drug, and it can selectively inhibit URAT1's transport of uric acid, thus inhibiting uric acid reabsorption and promoting uric acid excretion, and achieving the purpose of lowering blood uric acid concentration. SHR4640 has been approved to conduct a number of clinical studies, in addition to the combination with febuxostat tablets, its single-agent use in the treatment of patients with primary gout with hyperuricemia, a clinical phase III trial is also underway. (Information from the official website of Hengrui Medicine)

Kexing COVID-19 Vaccine was approved to be conditionally marketed in South Africa

       The South African Health Products Regulatory Authority (SAHPRA) recently announced that it had approved on June 14 the conditional marketing of China's KeXing COVID-19 vaccine Kerlafor in South Africa for the vaccination of adults in the country between the ages of 18 and 59 years, with a two-dose interval ranging from 14 to 28 days.In July 2021, the South African Health Products Regulatory Authority (SAHPRA) approved Kerlafor for conditional emergency use in South Africa. Since then, Kerlafor has been disclosing the results of clinical trials conducted in South Africa in a timely manner and complying with the pharmacovigilance reporting requirements of its risk management program by submitting regular vaccine safety update data. Up to now, Kexing Xinguan vaccine has been approved for emergency use in over 60 countries, regions and international organizations worldwide, and nearly 2.9 billion doses have been supplied globally. (Information from GBIHealth)