HANGZHOU, China and SHAOXING, China, Feb. 14, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) today announces that Shanghai Public Health Clinical Center initiated functional cure study of anti-PD-L1 antibody ASC22 (Envafolimab) in combination with Chidamide in patients infected by human immunodeficiency virus (HIV) with antiviral suppression.
Taipei, Taiwan –Aug. 17, 2021 –United BioPharma (UBP) announced today that two separated Investigational New Drug (IND) approvals have been granted by Taiwan FDA (UBP protocol No. A232) and by China National Medical Products Administration (NMPA; protocol No. A230) for two phase 2 proof-of-concept (POC) trials with UB-421 (an anti-CD4 monoclonal antibody) monotherapy alone or in combination with chidamide, a latency reversal agent (LRA), among virally suppressed patients under stable treatment with antiretroviral therapy (ART) to evaluate the application in HIV-1 functional cure. The objective is to examine the reduction of HIV reservoirs and dynamics of related biomarkers that may shed lights into the mechanism of “shock-and-kill” to achieve the HIV functional cure. The two POC studies with slightly different designs will be conducted in Kaohsiung Veteran General Hospital, Taiwan (A232 trial) and Guangzhou Eighth People’s Hospital, Guangzhou Medical University, Guangdong China (A230 trial), respectively.
On November 29, 2019, Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) announced that the company's lead innovative product Epidaza® (Chidamide), an oral subtype-selective histone deacetylase (HDAC) inhibitor, previously approved for recurrent and refractory peripheral T cell lymphoma in China, has received approval for marketing application in its second indication from NMPA. The indication includes Chidamide combined with aromatase inhibitor in postmenopausal patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer (ABC) treated with endocrine therapies for recurrence or progression.
Chipscreen Biosciences, a leading integrated Chinese biotech company specialized in discovery and development of novel small molecule pharmaceuticals with a primary focus in oncology, metabolic disease, and autoimmune diseases, announce the signing of a collaboration agreement with Innovent Biologics, Inc. (Innovent) to evaluate the safety and tolerability of Chipscreen's Chidamide and Innovent's Sintilimab in combination with an anti-VEGF monoclonal antibody IBI305 in patients with advanced colorectal carcinoma.
GNT Biotech & Medicals Co., Ltd. (GNTbm, TPEx Emerging: 7427) announced that it has awarded exclusive sales and marketing rights in Taiwan of anticancer drug Chidamide to pharmaceutical distribution company Taiwan Specialty Pharma Corp. (TSPC) for two indications; hormone receptor-positive, HER-2 negative late stage breast cancer in post-menopausal patients; and peripheral T-cell lymphoma (PTCL). The licensing agreement includes upfront and milestone payments of up to NT$30 million (approx US$1mil), with royalties from sales to be awarded separately.
Taiwan's GNT Biotech & Medicals recently announced that it has granted exclusive sales and marketing rights of anticancer drug Chidamide to pharmaceutical distribution company Taiwan Specialty Pharma Corp. (TSPC) for two indications; hormone receptor-positive, HER-2 negative late stage breast cancer in post-menopausal patients; and peripheral T-cell lymphoma (PTCL) in Taiwan.