•
China-based Alphamab Oncology (HKG: 9966)’s US partner Tracon Pharmaceuticals (NASDAQ: TCON) has provided an early positive update from a Phase II trial underway for envafolimab, the Alphamab-discovered programmed death-ligand 1 (PD-L1) antibody capable of subcutaneous injection. The pivotal ENVASARC trial, being conducted by Tracon in the US and UK, is…
•
Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has announced the interim results of part one of a Phase IIb clinical study for STP705, a therapeutic that combines TGF-β1/COX-2 with histidine-lysine polypeptide (siRNA/HKP) nanoparticle silencing. The trial is assessing the therapy as a treatment for cutaneous squamous cell carcinoma in…
•
Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the first subject dosed in a Phase I clinical trial in Australia for its independently developed HLX60 (recombinant anti-GARP humanized monoclonal antibody injection) in combination with Henlius’s innovative in-house anti-PD-1 mAb serplulimab. The trial is assessing the combination in treating general advanced…
•
China-based Everest Medicines (HKG: 1952) has announced that the company has achieved the preclinical proof-of-concept milestone for its mRNA rabies vaccine program. This new vaccine candidate for rabies post-exposure prophylactic was developed in partnership with Providence Therapeutics Holdings Inc., using a clinically validated mRNA technology platform. It can be used…
•
China-based online pharmacy 111 Inc. (NASDAQ: YI) reportedly initiated online retail sales of Pfizer Inc.’s oral COVID-19 therapy Paxlovid (nirmatrelvir, ritonavir) in China. The price for one box covering a single course of treatment was set at RMB 2,980 (USD 428.23). 111 later released a statement noting that the drug…
•
Suzhou-based Ascentage Pharma (HKG: 6855) unveiled preliminary data from the global Phase II clinical study for its APG-2575, alone or combined with Calquence (acalabrutinib) plus rituximab, in recurrent/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The results were released at the 64th American Society of Hematology (ASH) annual meeting this…
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced receiving clinical trial approval from the US FDA for its IMM2520, a bispecific antibody (BsAb) targeting CD47 and PD-L1 in solid tumors. Mechanism of Action and Preclinical ResultsIMM2520, featuring functional IgG1 Fc, can activate macrophages and T cells simultaneously by targeting CD47 and PD-L1…
•
China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced the positive results of a Phase II clinical study for its recombinant COVID-19 vaccine ReCOV in the Philippines as a sequential booster shot. The results showed that ReCOV as a sequential booster shot was superior to mRNA vaccine in…
•
China-based Treadwell Therapeutics presented results of the company’s CFI-400945 program, a first-in-class inhibitor of Polo-like Kinase 4 (PLK4), a critical regulator of centriole duplication, at the 64th American Society of Hematology (ASH) annual meeting. The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202…
•
China-based Asieris Pharmaceuticals (SHA: 688176) announced the first patient enrollment in a Phase II clinical study for its oral drug candidate APL-1202 in combination with the PD-1 inhibitor tislelizumab as a neoadjuvant therapy for muscular invasive bladder cancer (MIBC). The open-label, multi-center Phase I/II clinical study is designed to evaluate…
•
China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) announced the first patient administration of Hexvix (hexyl aminolevulinate hydrochloride) in the Lecheng medical pilot zone in Hainan province. Hexvix is an optical imaging agent used to perform Blue Light Cystoscopy to detect carcinoma of the bladder for…
•
China-based Ascletis Pharma Inc., (HKG: 1672) announced the positive topline results from its Phase I multiple ascending dose (MAD) study (NCT05523141) in healthy subjects for the oral RNA-dependent RNA polymerase (RdRp) inhibitor ASC10 being developed as treatment for COVID-19. The Phase I data demonstrated that all doses of ASC10, including…
•
China-based Angel Pharmaceuticals Ltd announced the latest results of the global Phase I/Ib clinical study for CPI-818, a first-in-class ITK inhibitor co-developed by US partner Corvus Pharmaceuticals, at the American Society of Hematology (ASH) 2022 annual meeting. The study has shown the anti-tumor activities in T-cell lymphoma (TCL), alongside therapeutic…
•
China-based JW Therapeutics (HKG: 2126) presented the latest clinical data on Carteyva (relmacabtagene autoleucel injection) in Chinese adults with relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory mantle cell lymphoma (r/r MCL) at the 64th American Society of Hematology (ASH) annual meeting. Efficacy and Safety in Relapsed/Refractory Follicular LymphomaIn the pivotal…
•
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented the latest clinical data on golidocitinib (DZD4205) at the 64th American Society of Hematology (ASH) annual meeting. Global Multi-Center Phase I/II StudyA global multi-center Phase I/II study for golidocitinib in recurrent refractory peripheral T-cell lymphoma (r/r PTCL) included a total of 51…
•
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced the acceptance for review of its Investigational New Drug (IND) filing for its in-house developed selective ATR kinase inhibitor TCC1727 by the US FDA. ATR Kinase and TCC1727 MechanismATR, namely ataxia telangiectasia and Rad-3-related protein, is a family of protein serine/threonine kinases and…
•
US major Biogen’s (NASDAQ: BIIB) Alzheimer’s disease (AD) therapy aducanumab has been administered to a Chinese patient for the first time via the Hainan branch of Ruijin Hospital. The hospital is part of the Boao Lecheng medical pilot zone in Hainan province. Aducanumab: FDA Approval and IndicationAducanumab, a beta amyloid…
•
Stemirna Therapeutics Co., Ltd, an mRNA drug developer based in Shanghai, has obtained Emergency Use Authorization (EUA) in Laos for its in-house developed COVID-19 mRNA vaccine, used for people aged 18 and above to prevent COVID-19 pneumonia through active immunization. The product, the first home-grown COVID-19 mRNA vaccine approved in…
•
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) announced the completion of the enrollment of all subjects and their clinical observation, alongside the clinical study summary report of a Phase I clinical study for its Category 1 GST-HG171. The results showed that GST-HG171 had good safety, tolerability, and pharmacokinetics, which…
•
China-based Alphamab Oncology (HKG: 9966) updated the clinical studies for its KN046 and KN026 at the San Antonio Breast Cancer Symposium 2022 annual meeting. KN046/Albumin Paclitaxel in Metastatic TNBCThe Phase II clinical trial is designed to evaluate the efficacy, safety, and tolerability of KN046 combined with albumin paclitaxel in the…