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Transcenta’s Osemitamab Receives FDA Orphan Drug Designation for Pancreatic Cancer
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China-based biotechnology company Transcenta Holdings Ltd (HKG: 6628) has announced that its drug TST001 (osemitamab), a humanized ADCC-enhanced anti-Claudin 18.2 monoclonal antibody (mAb), has received orphan drug designation (ODD) status from the US FDA for the treatment of pancreatic cancer. This follows a previous ODD granted in 2021 for the…
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ImmuneOnco Achieves Full Enrollment in Phase II Study of IMM01 for CMML
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced the successful completion of patient enrollment in its Phase II clinical study (IMM01-02), which investigates the combination of IMM01 with azacitidine for the treatment of naïve chronic myelomonocytic leukemia (CMML). The study has fully enrolled 20 patients, marking a significant milestone in the…
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Kintor Pharmaceutical Realigns Funds from COVID-19 Studies to Other Pipeline Candidates
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced a strategic change in the allocation of proceeds from previous subscriptions. The company has decided to redirect HKD 509 million (USD 64.8 million), initially intended for the clinical development and commercialization of proxalutamide, pyrilutamide, and AR-PROTAC GT20029, away from clinical studies for…
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Shanghai Pharmaceuticals’ SPH4336 Earns Orphan Drug Status for Liposarcoma Treatment
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Shanghai Pharmaceuticals, a leading pharmaceutical company based in China (HKG: 2607, SHA: 601607), has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate, SPH4336. This designation is for the potential treatment of liposarcoma, a rare form of cancer.…
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Novartis’ Kisqali Demonstrates Improved iDFS in Phase III NATALEE Study for Early Breast Cancer
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that the multi-center, randomized, open-label Phase III NATALEE study has achieved its primary endpoint of invasive disease-free survival (iDFS). The study assessed the efficacy of Kisqali (ribociclib) in combination with endocrine therapy (ET) for hormone receptor-positive/human epidermal growth factor receptor 2 negative…
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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…
