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Zelgen Biopharmaceuticals’ ZGGS18 Receives NMPA Approval for Solid Tumor Treatment
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate ZGGS18. The molecule will be assessed as a treatment for general advanced solid tumors. Drug DetailsZGGS18 is a bispecific antibody (BsAb) targeting vascular…
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Sanjin Pharma’s Subsidiary Gets NMPA Nod for BC007 Cancer Study
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China-based Guilin Sanjin Pharmaceutical Co. Ltd (SHE: 002275) announced that its subsidiary, Dragon Boat Biopharmaceutical (Shanghai) Co., Ltd, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of BC007. The study will assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy…
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Luye Pharma’s Goserelin Acetate Injectable Accepted for Breast Cancer Review
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China-based Luye Pharma Group (HKG: 2186) announced that another market filing for its goserelin acetate sustained-release injectable microspheres (LY01005) as a treatment for breast cancer has been accepted for review by China’s Center for Drug Evaluation (CDE). The drug is already under review for its use in treating prostate cancer.…
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Gilead Transfers Trodelvy Asian Rights to Everest Medicines for USD280m
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US pharmaceutical major Gilead Sciences Inc. (NASDAQ: GILD) today announced an agreement with Everest Medicines (HKG: 1952) to transfer the development and commercialization rights for Trodelvy (sacituzumab govitecan) in Asian territories. Trodelvy is a TROP-2 targeted antibody drug conjugate (ADC). The deal regains control of the drug’s Asian rights for…
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Henlius Biotech’s HanBeiTai sBLA Accepted for HCC Treatment Review
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab), has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indication is hepatocellular carcinoma (HCC). Drug BackgroundHanBeiTai is also awaiting a regulatory decision…
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Roche’s Rozlytrek Wins NMPA Approval for ROS1+ NSCLC Treatment
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Swiss pharmaceutical giant Roche’s China unit announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approved indication is for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug BackgroundEntrectinib, the first ROS1 inhibitor with…
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EQRx Accelerates US Development of Two Chinese-Licensed Cancer Drugs
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US-based pharma EQRx Inc. (Nasdaq: EQRX) has revealed its latest plans to accelerate the US market development of two innovative drugs licensed from Chinese partners. The company’s Q2 2022 financial report shows that a US-led Phase IIIb bridging study has recently been initiated for aumolertinib as a first-line treatment of…
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E-Health Now Raises Funds for Oncology and Cardiovascular Digital Health Products
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E-Health Now, a Beijing-based commercial insurance-focused health management service solutions provider, has raised an undisclosed amount of funds in a Series A++ financing round. The round was led by Borchid Capital, with participation from Tongji Fund. The proceeds will be used for the research and development of specialty digital health…
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Zelgen Biopharmaceuticals’ Donafenib Receives NMPA Approval for Thyroid Cancer
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that the supplementary New Drug Application (sNDA) for its Category 1 anti-cancer drug donafenib in locally advanced / metastatic radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) has been approved by the National Medical Products Administration (NMPA). This is the second indication approval for…
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InnoCare Pharma’s Orelabrutinib sNDA Accepted for Marginal Zone Lymphoma
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InnoCare Pharma (HKG: 9969) announced that a supplemental New Drug Application (sNDA) for its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib has been accepted for review by the Center for Drug Evaluation (CDE). The Chinese firm is seeking a new indication for patients with relapsed or refractory marginal zone lymphoma. Drug…
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BeiGene Partners with Jilin Cancer Hospital for Cancer Drug Development
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has entered into a clinical study partnership with Jilin Cancer Hospital. The collaboration is based on the hospital’s “Malignancy New Drug Creation Platform” and aims to bolster cancer drug development and accelerate BeiGene’s drug development activities. Financial details of the partnership were…
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Arbele’s ARB202 Enters Phase I Trial for Advanced Gastrointestinal Cancer
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Hong Kong-based biopharma Arbele announced that its CDH17 × CD3 bispecific T-Cell engager antibody, ARB202, has entered a Phase I clinical trial in the United States for advanced gastrointestinal cancer patients. The potential first-in-class drug has been dosed in the first patient, with the Phase I multi-center, open-label dose-escalation study…
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HutchMed and AstraZeneca’s Tagrisso-Orpathys Combo Shows Promise in NSCLC Study
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Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) and AstraZeneca (AZ, NASDAQ: AZN) announced the preliminary results of the Phase II SAVANNAH study evaluating the combination of Tagrisso (osimertinib) and Orpathys (savolitinib) in patients with epidermal growth factor receptor – mutated (EGFRm) non-small cell lung cancer (NSCLC) with high levels…
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BeiGene’s Tislelizumab Meets Primary Endpoint in Global HCC Study
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the global Phase III RATIONALE 301 study evaluating tislelizumab in first – line unresectable hepatocellular carcinoma (HCC) has met its primary endpoint. The study demonstrated that the programmed death – 1 (PD – 1) inhibitor tislelizumab was non – inferior to…
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GeneoDx Biotech’s Cervical Cancer Screening Kit Wins NMPA Approval
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Shanghai GeneoDx Biotech Co., Ltd, a medical diagnosis unit of Sinopharm, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its “human ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 gene methylation detection kit (fluorescent PCR method).” This marks the first approval in China…
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Dizal Pharma’s Sunvozertinib Shows Promise in NSCLC with EGFR Exon 20 Insertion
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has unveiled the latest positive data for its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008). The drug is in late-stage global studies for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (Exon20ins) mutation, both in the second-line stage following…
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Hywin Holdings to Acquire Life Infinity for Health Management Expansion
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China-based wealth management firm Hywin Holdings is set to move into the health management business through the acquisition of Beijing iLife3 Technology Co., Ltd (Life Infinity). The share transfer and capital increase agreement will require over RMB140 million (USD20.7 million) for Hywin to gain a controlling equity interest. The transaction…
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HutchMed’s FRESCO-2 Study for Elunate in Colorectal Cancer Meets Primary Endpoint
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced that the pivotal global Phase III FRESCO-2 study for its VEGFR 1/2/3 inhibitor Elunate (fruquintinib) in advanced refractory metastatic colorectal cancer (CRC) has met the primary overall survival (OS) endpoint. The multi-center study, initiated in July 2020, recruited 691 patients…
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Immvira’s Oncolytic Virus MVR-C5252 Receives FDA Orphan Drug Designation for Glioma
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Shenzhen-based Immvira Co., Ltd, a biotech company focused on oncolytic viruses, announced that it has received orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its herpetic oncolytic virus MVR-C5252. The designation is for the drug’s use in treating malignant glioma. Drug DetailsMVR-C5252, developed in-house…
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Transcenta Appoints Dr. Caroline Germa as Global Drug Development Chief
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) announced the appointment of Dr. Caroline Germa as its executive vice president of global drug development and chief medical officer (CMO). Dr. Germa will report directly to CEO Dr. Qian Xueming. Role and ResponsibilitiesDr. Germa will lead the global development and translational research…
