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Keymed Biosciences’ CM310 Achieves Primary Endpoints in Phase III Atopic Dermatitis Study
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China-based Keymed Biosciences Inc., a prominent player in the biopharmaceutical industry (HKG: 2162), has announced that its IL-4Rα monoclonal antibody (mAb) drug candidate, CM310, has successfully reached its primary endpoints in a confirmatory Phase III clinical study for the treatment of moderate to severe atopic dermatitis (AD). Phase III Study…
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CDE Grants Priority Review Status to TQB3454, HLX208, and Infigratinib for Cancer Treatments
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The Center for Drug Evaluation (CDE) website has indicated that Chia Tai Tianqing’s TQB3454, Henlius Bio’s HLX208, and LianBio’s infigratinib are all set to be awarded priority review status as Category 1 chemical drugs. TQB3454: A Promising IDH1 Mutase InhibitorTQB3454 is an in-house developed IDH1 mutase inhibitor intended for the…
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Brii Biosciences Halts Development of Antibody Cocktail for COVID-19 Treatment
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Brii Biosciences has announced a strategic decision to end the manufacturing and further development of the amubarvimab/romlusevimab combination treatment regimen for COVID-19. According to the company’s recent 2022 financial report, the antibody cocktail had been commercially available in China from July 2022 following an emergency use authorization (EUA) and had…
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CSPC Pharmaceutical Receives NMPA Approval for Generic Otezla Equivalent
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its generic version of Celgene’s Otezla (apremilast) has obtained marketing approval from the National Medical Products Administration (NMPA), signifying that it has passed the generic quality and efficacy consistency evaluation. Apremilast’s Background and Clinical Necessity in ChinaApremilast, an oral small…
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CANbridge Pharmaceuticals Completes Enrollment in Phase II GBM Trial for CAN008
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Sino-US biopharma CANbridge Pharmaceuticals (HKG: 1228) has announced the completion of patient enrollment in a Phase II trial for its pipeline candidate CAN008 (asunercept) in combination with temozolomide for the treatment of glioblastoma multiforme (GBM). The multi-center, randomized, placebo-controlled study, which is potentially registrational, has recruited a total of 117…
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Chongqing Genrix’s Xeligekimab for Psoriasis Accepted for Market Approval Review
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China-based Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443) has announced that the market approval filing for its in-house developed Category 1 biological product, Xeligekimab, for the treatment of moderate to severe plaque psoriasis has been accepted for review. This development marks a significant step forward for the company and the…
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CSPC Pharmaceutical’s mRNA Vaccine SYS6006 Receives Emergency Use Authorization in China
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has obtained an Emergency Use Authorization (EUA) for its in-house developed COVID-19 mRNA vaccine, SYS6006, in China. This approval marks a significant milestone as it is the first for a domestically developed mRNA product in the country. Design and…
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Sihuan Pharmaceutical’s XZP-KM602 and XZP-6877 Gain Clinical Trial Approvals
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its minority-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd, has obtained clinical trial approvals for two in-house developed drugs: CD80 mutant Fc fusion protein XZP-KM602 and DNA dependent protein kinase (DNA-PK) inhibitor XZP-6877. Both drugs are aimed at treating advanced solid…
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Sihuan Pharmaceutical’s XZP-KM602 and XZP-6877 Secure Clinical Trial Approvals for Solid Tumors
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its minority-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd, has obtained clinical trial approvals for two in-house developed drugs: CD80 mutant Fc fusion protein XZP-KM602 and DNA dependent protein kinase (DNA-PK) inhibitor XZP-6877. Both drugs are aimed at treating advanced solid…
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CSPC Pharmaceutical’s mRNA Vaccine SYS6006 Receives Emergency Use Authorization in China
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has revealed that it has obtained an Emergency Use Authorization (EUA) for its in-house developed COVID-19 mRNA vaccine, SYS6006, in China. This approval marks a significant milestone as it is the first for a domestically developed mRNA product in the country. SYS6006 Design…
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Sihuan Pharmaceutical’s KM501 Receives Clinical Trial Approval for HER2-Positive Tumors
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its XZP-KM501 (KM501) in solid tumors with HER2 positive, middle to low-expression. This marks a significant step forward in the development of innovative treatments for…
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4B Technologies’ FB1001 Receives CDE Approval for Clinical Trials
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China-based 4B Technologies Investments Ltd has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its potential first-in-class monoclonal antibody (mAb) FB1001 (ZG103). This marks a significant milestone in the development of the drug candidate, which was developed by the company’s founder, Dr.…
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RemeGen’s RC48 Receives Two Clinical Trial Approvals for Breast Cancer Treatments
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RemeGen Ltd (HKG: 9995) has announced the receipt of two clinical trial approvals for its antibody-drug conjugate (ADC) candidate RC48 (disitamab vedotin). The Chinese firm is set to assess the drug as a neo-adjuvant therapy for HR-positive, HER2 low-expression breast cancer, either in combination with Junshi Bio’s (HKG: 1877, SHA:…
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Luye Pharma’s Lurbinectedin Gains Priority Review Status for SCLC Treatment
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The Center for Drug Evaluation (CDE) website indicates that China-based Luye Pharma Group’s (HKG: 2186) lurbinectedin (LY01017), an RNA polymerase II inhibitor, is set to obtain priority review status for the treatment of metastatic small cell lung cancer (SCLC) with tumor progression during or after platinum-based chemotherapy. Development and Mechanism…
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Guangdong Zhongsheng’s RAY1216 Receives Conditional Approval for COVID-19 Treatment
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for its drug candidate RAY1216, a 3CL protease (3CLpro) inhibitor. The drug is set to be assessed as a treatment for mild to moderate COVID-19. Mechanism…
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Hengrui Pharmaceuticals’ HRS-5965 Receives NMPA Approval for Clinical Study in Hemolytic Anemia
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-5965. The study will focus on complement-mediated hemolytic anemia, including conditions such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic…
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Sunshine Guojian Completes Patient Enrollment for SSGJ-611 Phase II Study in Atopic Dermatitis
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced the completion of patient enrollment in a China-based Phase II clinical study for its SSGJ-611, an IL-4Rα monoclonal antibody (mAb). The drug is being evaluated as a treatment for moderate to severe atopic dermatitis…
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Henlius Biotech’s Serplulimab Accepted for EMA Review for ES-SCLC Treatment
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Shanghai Henlius Biotech (HKG: 2696) has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The drug is filed for its first indication as a first-line treatment in combination with chemotherapy for extensive-stage small cell lung cancer…
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AstraZeneca’s Calquence Receives Conditional Approval in China for MCL
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AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received conditional market approval in China for its next-generation Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is approved for the first indication in adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. Clinical Trial…
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Hinova Pharmaceuticals’ HC-1119 NDA Accepted for Review by NMPA
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Chengdu-based biotech Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the New Drug Application (NDA) filing for its Category 1 drug HC-1119 has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for patients with metastatic castrate-resistant prostate cancer (mCRPC) who have failed to…
