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InnoCare Pharma Initiates Clinical Trial for TYK2 Inhibitor ICP-488 in Psoriasis Patients
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced a significant milestone in the clinical development of its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, with the dosing of the first psoriasis patient in China. This marks a progressive step towards addressing the treatment needs for psoriasis and other…
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Ascentage Pharma’s Olverembatinib Gets NMPA Greenlight for Phase III Study in Ph+ ALL
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China-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a pivotal regulatory Phase III clinical study. The study will evaluate the combination of its Category 1 drug, olverembatinib, with chemotherapy in newly diagnosed Philadelphia chromosome positive (Ph+) acute…
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InnoCare Pharma and Keymed Biosciences Initiate Clinical Trial for ICP-B02 with First Subcutaneous Injection
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InnoCare Pharma (HKG: 9969; SHA: 688428) and Keymed Biosciences Inc., (HKG: 2162) have announced a significant milestone in their joint development of ICP-B02 (CM355), a bispecific antibody (BsAb) targeting CD20 and CD3. The first subcutaneous injection administration has been successfully administered to a Chinese patient, marking a new route of…
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Jiangsu Hengrui Medicine Gets NMPA Approval for HRS-4357 Clinical Study in Prostate Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 radiotherapeutic drug, HRS-4357. This novel molecule is under development for the treatment of prostate specific…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for BL-B01D1 Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its drug candidate, BL-B01D1. This in-house developed antibody-drug conjugate (ADC) targets EGFR and HER3, key drivers…
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Joincare Pharmaceutical Initiates Phase III Study for Anti-IL-17A mAb in Plaque Psoriasis
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced the initiation of a Phase III clinical study for its anti-IL-17A monoclonal antibody (mAb) in the treatment of moderate to severe plaque psoriasis. The study, which was approved in China in February 2020, marks a significant step forward in…
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Huadong Medicine Receives NMPA Approval for DR30206 Clinical Study in Advanced Solid Tumors
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable DR30206, a Category 1 biologic product, in the treatment of advanced solid tumors. DR30206: A Promising Antibody Fusion Protein Targeting PD-L1,…
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Sinocelltech Group Receives NMPA Approval for COVID-19 Vaccine Bridging Phase II Study
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study. The study will assess the safety and immunogenicity of SCTV01E-2, an S trimer protein vaccine developed to combat COVID-19. This vaccine is designed for individuals…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase III Studies of Gallium Edotreotide Injection
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with Phase III clinical studies for its gallium [68Ga] edotreotide injection and gallium [68Ga] edotreotide injection preparation kit. Gallium [68Ga]…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-10518 Clinical Study in Endometriosis Pain
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug HS-10518 (TU2670). The study will focus on the treatment of moderate to severe pain associated with endometriosis and menorrhagia associated with…
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Shanghai Junshi Biosciences Gets FDA Approval for Phase III Study of Tifcemalimab in Small-Cell Lung Cancer
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a randomized, double-blind, placebo-controlled, global multi-center Phase III study for its drug tifcemalimab (TAB004/JS004) in combination with Tuoyi (toripalimab). This consolidation therapy is intended for patients with limited-stage small-cell…
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AIM Vaccine Receives NMPA Approval for mRNA Vaccine Clinical Study Targeting COVID-19 Variants
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a Phase I/II clinical study for its mRNA vaccine targeting COVID-19 variants Delta and Omicron BA.5. This development marks a significant step in the company’s efforts to combat the evolving…
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Shandong Buchang Pharmaceuticals’ BC001 Gets Clinical Trial Approval for Solid Tumors
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced receiving clinical trial approval for its investigational injectable product BC001. The drug is intended for use in combination with pucotenlimab for the treatment of advanced solid tumors, including first-line HER-2 negative advanced or metastatic gastric cancer/adenocarcinoma at…
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Beijing Tiantan Biological Completes Phase I Study for Recombinant Coagulation Factor VIIa
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China-based Beijing Tiantan Biological Products Co., Ltd (SHA: 600161) has announced the conclusion of a Phase I clinical study for its recombinant human coagulation factor VIIa for injection. The company is now preparing for a Phase III study, which is expected to commence soon. This advanced treatment is aimed at…
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Grand Pharmaceutical Initiates Phase I Study for TLX250-CDx in Renal Mass Imaging
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the Phase I clinical study for its TLX250-CDx (89Zr-DFO-girentuximab), an imaging agent licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a deal valued at up to USD 225 million in 2020. Phase I Study Design…
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CSPC Pharmaceutical Group Gets NMPA Approval for JMT203 Cancer Cachexia Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its in-house developed Category 1 antibody, JMT203. This marks a significant step forward in the development of this novel treatment for cancer cachexia.…
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Henlius Biotech’s HLX13 Biosimilar Gets NMPA Approval for Liver Cancer Clinical Trial
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Shanghai Henlius Biotech, Inc (HKG: 2696) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its HLX13, a biosimilar of US major Bristol-Myers Squibb’s (BMS, NYSE: BMY) Yervoy (ipilimumab), for the treatment of liver cancer. HLX13: A CTLA-4 Monoclonal Antibody for Cancer TreatmentsHLX13 is a…
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Jiangsu Kanion Pharmaceutical Gets FDA Approval for KYS202002A Clinical Study in Multiple Myeloma
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its pipeline candidate KYS202002A, focusing on recurrent/refractory multiple myeloma (R/R MM). This follows the molecule’s approval for clinical trials in China in…
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Haisco Pharmaceutical’s HSK31679 Receives Clinical Trial Approval for NASH Treatment
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its in-house developed Category 1 drug candidate, HSK31679, has obtained clinical trial approval for the treatment of non-alcoholic steatohepatitis (NASH). HSK31679: A Selective THR-β Agonist for Lipid MetabolismHSK31679 is a highly selective thyroid hormone β receptor (THR-β) agonist that…
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S-Evans Biosciences Receives NMPA Tacit Approval for Stem Cell Therapy in ARDS
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S-Evans Biosciences, a stem cell specialist based in Hangzhou, has obtained tacit clinical trial approval from the National Medical Products Administration (NMPA) for its “human umbilical cord mesenchymal stem cell injection” in the treatment of moderate to severe acute respiratory distress syndrome (ARDS). Product Development and ARDS OverviewThe in-house developed…
