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Hemay Pharma Completes Series D Financing for Autoimmune and Oncology Drugs
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China-based Ganzhou Hemay Pharmaceutical Co., Ltd, an innovative drug developer focused on autoimmune diseases and oncology, has announced the completion of a Series D financing round at close to RMB 300 million (USD 44.18 million). This significant funding round was led by Hongfu Investment, with contributions from Jihan Capital, Hainan…
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SciClone Pharmaceuticals Files for Hong Kong Market Approval of Danyelza
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017, has announced that a market approval filing has been made in Hong Kong for its Danyelza (naxitamab) in recurrent or refractory high-risk neuroblastoma. This marks a significant step in the global expansion of this innovative…
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Asieris Partners with ReviR Therapeutics for Urogenital Cancer Research
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has struck a partnership with compatriot firm ReviR Therapeutics, an artificial-intelligence (AI) and gene tech-powered start-up. The collaboration aims to utilize ReviR’s in-house developed AI drug research and development (R&D) platform and targeted RNA technology to conduct research…
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Harbour BioMed’s Anti-CCR8 Monoclonal Antibody HBM1022 Receives FDA IND Approval
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Harbour BioMed (HBM), which operates out of the Netherlands, the United States, and Suzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its in-house developed HBM1022, a novel anti-C-C chemokine receptor type 8 (CCR8) monoclonal antibody (mAb). This marks a significant milestone in the…
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Gracell’s CAR-T Therapy GC012F Receives FDA IND Approval
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Shanghai-based biotech Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the US FDA for its chimeric antigen receptor (CAR) T cell candidate GC012F. This dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step forward in the development…
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BeiGene Launches Mental Health Program for Cancer Patients
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China-based biotech BeiGene (Nasdaq: BGNE; HKG: 6160; SHA: 688235) has announced the launch of a new mental health program focused on cancer patients. The “Talk About It: Cancer and Mental Health” program, which includes the website CancerandMentalHealth.com, is designed to ensure that mental health is considered a vital part of…
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AnHeart Therapeutics Partners with Guardant Health for Taletrectinib Diagnostics
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Sino-US biopharma AnHeart Therapeutics and US precision oncology firm Guardant Health Inc. (NASDAQ: GH) have unveiled a partnership under which Guardant will provide companion diagnostics in support of AnHeart’s taletrectinib. This collaboration aims to enhance the development, regulatory approval, and commercialization of Guardant360 CDx and Guardant360 TissueNext assays in the…
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Grand Pharma’s TLX101 Accepted for NMPA Review for Glioblastoma Treatment
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its TLX101, a radionuclide drug conjugate (RDC) being developed to treat glioblastoma multiforme, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development…
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Mabwell’s Novel ADC 9MW2921 Accepted for NMPA Review
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that a clinical trial filing for its novel antibody-drug conjugate (ADC) 9MW2921 has been accepted for review by the National Medical Products Administration (NMPA). The firm is seeking to assess the ADC as a treatment for general solid tumors, marking…
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Roche Reports 2% YOY Growth in 2022; Ocrevus and Hemlibra Drive Sales
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Swiss pharmaceutical giant Roche (SWX: RO) released its 2022 financial report this week, recording CHF 63.3 billion (USD 69.5 billion) in global sales. The company achieved a modest 2% year-on-year (YOY) growth at constant exchange rates (CER), impacted by lower COVID-19-related sales across both its Pharmaceuticals and Diagnostics divisions. Pharmaceuticals…
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GenScript’s CAR-T Therapy Carvykti Achieves $55M in Sales, Awaits China Approval
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that sales of its subsidiary company Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), reached USD 55 million as of December 31, 2022. This figure, yet to be independently audited,…
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Virpax Pharmaceuticals Seeks China Licensing Partner for Non-Opioid Pain Drug Envelta
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US-based Virpax Pharmaceuticals Inc. (NASDAQ: VRPX) has announced the engagement of advisors to help search for a licensing partner for its non-opioid pain drug Envelta (NES100; enkephalin nasal formulation) in China. Virpax has appointed New England Investors as its out-licensing advisor to support the commercialization of Envelta, a treatment for…
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Antengene Launches Phase I CLINCH Study for ATG-022 in Australia
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China-based Antengene Corporation Ltd (HKG: 6996) has received approval from Australia’s Therapeutic Goods Administration (TGA) to commence the Phase I CLINCH study for its antibody-drug conjugate (ADC) ATG-022. The study targets advanced or metastatic solid tumors, with a focus on gastric cancer patients expressing Claudin 18.2. ATG-022: Mechanism and Preclinical…
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Henlius Begins Phase I Trial for Biosimilar HLX15 Targeting Multiple Myeloma
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Shanghai Henlius Biotech (HKG: 2696) has announced the dosing of the first subject in a Phase I clinical study for its biosimilar candidate HLX15, targeting Johnson & Johnson’s (J&J, NYSE: JNJ) blockbuster drug Darzalex (daratumumab). The study aims to evaluate the pharmacokinetics, safety, and immunogenicity of HLX15 in healthy male…
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Hengrui’s HER2-Targeted ADC SHR-A1811 Gains NMPA Clearance for Clinical Trial
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase Ib/II clinical study for its investigational HER2-targeted antibody-drug conjugate (ADC), SHR-A1811. The study will evaluate the drug in patients with unresectable or metastatic breast cancer with low…
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Hengrui’s Lutetium [177Lu] Oxy-Octreotide Gains Clinical Clearance in China
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its lutetium [177Lu] oxy-octreotide. The drug is being developed to treat unresectable or metastatic, progressive, well-differentiated (G1 and G2) neuroendocrine tumors that are somatostatin receptor-positive, specifically targeting gastrointestinal and pancreatic neuroendocrine…
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Betta Pharmaceuticals Gains FDA Approval for Clinical Trial of BPI-460372
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China’s Betta Pharmaceuticals (SHE: 300558) has announced receiving clinical trial approval from the US FDA for its Category 1 drug candidate BPI-460372. The trial will evaluate the drug as a potential treatment for advanced solid tumors, marking a significant milestone in the company’s oncology pipeline. BPI-460372: Targeting the Hippo Signaling…
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Zhifei Renews Vaccine Supply Agreement with Merck Sharp & Dohme
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China-based Chongqing Zhifei Biological Co., Ltd (SHE: 300122) has announced the renewal of a supply, distribution, and co-promotion agreement with Merck Sharp & Dohme (MSD, NYSE: MRK) for the US firm’s vaccine products. Under the renewed agreement, Zhifei aims to secure the supply of MSD’s human papillomavirus (HPV) and pentavalent…
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Kelun’s SKB264 Receives Breakthrough Therapy Designation for Lung Cancer
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE). The designation is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung…
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Hengrui’s Camrelizumab-Apatinib Combo Approved for Liver Cancer in China
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). This marks the…
