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Chipscreen Biosciences’ CS12088 Gets NMPA Clearance for Hepatitis B Study
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China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that the National Medical Products Administration (NMPA) has granted clearance to conduct a study of its investigational drug CS12088 in adult patients with chronic hepatitis B. Drug Mechanism and Preclinical DataCS12088 is an HBV nucleocapsid assembly regulator that interferes with the…
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Chipscreen Biosciences Gains NMPA Approval for Epidaza Phase III Study
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China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III study assessing its Epidaza (chidamide) combined with CHOP in naive, peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH). This approval marks a significant step…
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Chipscreen’s Epidaza Patent Faces Invalidation Request Review
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China-based Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has announced that a patent invalidation request filed by compatriot firm Chia Tai Tianqing relating to its Epidaza (chidamide) has been accepted for review by the China National Intellectual Property Administration (CNIPA). This development marks a significant legal milestone in the protection…
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Shenzhen Chipscreen Biosciences Gets NMPA Approval for CS231295 Solid Tumor Study
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a China-based biopharmaceutical company, has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate CS231295 in advanced solid tumors. CS231295: A Promising Multi-Target InhibitorCS231295 is a multi-target protein kinase inhibitor that has…
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Chipscreen Biosciences’ Chiauranib Phase III Trial Results for SCLC Announced
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China-based innovative drug company Chipscreen Biosciences (SHA: 688321) has announced the completion of the analysis of results from the Phase III clinical trial for its drug candidate chiauranib, used as a monotherapy for third-line and above small cell lung cancer (SCLC). The independent review committee (IRC) has assessed the trial’s…
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Shenzhen Chipscreen Biosciences Announces Private Placement to Fund Drug R&D and Expansion
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China-based biopharmaceutical company Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has announced plans for a private placement of 122,000,000 shares, valued at RMB 960 billion (USD 133 million). This strategic move aims to bolster the company’s financial position and support its research and development (R&D) initiatives. Investment in In-House Drug…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Clinical Study
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China-based biopharmaceutical company Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its category 1 innovative drug, chiauranib. The study will evaluate chiauranib in combination with a programmed-death (PD)-(ligand) 1 monoclonal antibody and chemotherapy as a…
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Shenzhen Chipscreen Biosciences’ Tivozanib Secures NMPA Approval for ES-SCLC Phase III Trial
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Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) has announced that the National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Tivozanib in combination with PD-(L)1 monoclonal antibodies and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Tivozanib, a novel multi-target inhibitor developed…
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Chipsscreen Biosciences and Zhejiang Hisun Pharmaceutical End Strategic Partnership for Chiglitazar Launch
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China-based Chipscreen Biosciences Co., Ltd (SHA: 688321) has reached an agreement with Zhejiang Hisun Pharmaceutical Co., Ltd (SHA: 600267) to terminate their strategic partnership, which was initially formed in December 2020 to support the launch of the hypoglycemic drug chiglitazar (Bilessglu) for type 2 diabetes in 19 provinces, including Henan,…
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Shenzhen Chipscreen Advances CS231295 for Cancer Treatment as IND Accepted by NMPA
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On October 17, Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that its innovative Class 1 national drug candidate, CS231295, for cancer treatment has received acceptance for its clinical trial application (IND) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China (Acceptance Numbers:…
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Chipscreen’s HDAC Inhibitor Chidamide to be Tested in Combination Therapy for CRC by NMPA
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical trial. The trial is designed to evaluate the efficacy and safety of Epidaza (chidamide) in combination with the PD-1 inhibitor sintilimab…
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NMPA Approves Chengdu Chipscreen’s Bilessglu for Type 2 Diabetes in Combination with Metformin
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The National Medical Products Administration (NMPA) has granted approval for Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321)’s Category 1 drug Bilessglu (chiglitazar sodium) for use in combination with metformin to treat type 2 diabetes. This decision marks another milestone for the Chinese pharmaceutical company, which has developed chiglitazar as a…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Phase II Trial in Pancreatic Cancer
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 innovative drug, chiauranib. The drug will be evaluated in combination with chemotherapy…
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Chipscreen’s Chidamide in Sight of Breakthrough Therapy Designation in China for MSS/pMMR Colorectal Cancer
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that its drug Epidaza (chidamide) is on track to receive a breakthrough therapy designation (BTD) in China. The potential designation is for the use of chidamide in combination with PD-1 inhibitor sintilimab and bevacizumab for…
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China’s NMPA Approves Shenzhen Chipscreen’s Chidamide for DLBCL Indication
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Shenzhen Chipscreen Biosciences Co., Ltd, a biopharmaceutical company based in China, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Epidaza (chidamide). The drug is indicated for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2…
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Chipscreen NewWay Biosciences Initiates Phase I Trial for PD-1/CD40 Bispecific Antibody Candidate NWY001
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China-based Chengdu Chipscreen NewWay Biosciences Co., Ltd has announced that the first patient has been dosed in a Phase I clinical trial for its investigational PD-1/CD40 bispecific antibody (BsAb) candidate, NWY001. The multi-center, non-random, open-label trial is conducted under the leadership of Sun Yat-Sen University Cancer Center, with objectives to…
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Shenzhen Chipscreen Biosciences Gets NMPA Approval for Phase I Study of CS32582 in Psoriasis
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its investigational drug CS32582 in patients with psoriasis. This approval marks a significant step forward in the…
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CASI Pharmaceuticals Enters Assignment Agreement with Mundipharma for Folotyn Commercialization in China
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US-based CASI Pharmaceuticals Inc., (NASDAQ: CASI) has announced the execution of an assignment agreement with Mundipharma International Corporation Limited (MICL), Mundipharma Medical Company (MMCo), and Acrotech Biopharma Inc. (Acrotech) for the commercialization of Folotyn (pralatrexate) in China. The financial details of the agreement have not been disclosed. Folotyn (Pralatrexate) for…
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Chipscreen’s Epidaza Receives TFDA Approval for Breast Cancer Treatment in Taiwan
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Shenzhen Chipscreen Pharmaceutical Co., Ltd’s partner, GNT Biotech & Medicals Corporation, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for Epidaza (chidamide, Kepida in TW). This innovative class 1-selective oral histone deacetylase inhibitor was originally discovered by Chipscreen. Indication and Target Patient…
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Biocytogen’s YH008 Gets NMPA Approval for Phase I Study
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd has announced receiving approval from the China National Medical Products Administration (NMPA) to conduct an open-label Phase I dosage escalation study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of YH008, an internally developed first-in-class PD-1 x CD40 bispecific antibody (BsAb)…
