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Hangzhou-based Oriomics, a specialist in cancer screening based on circulating tumor DNA (ctDNA) methylation detection, has reportedly raised close to RMB 100 million (USD 13.7 million) in a Series B+ financing round. The round was led by Fortune Capital, with additional investments from Tao Capital, Hotgen Biotech, and the company’s…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase III clinical study for its Category 1 innovative drug ABSK021 (pimicotinib), which is being assessed as a treatment for tendon sheath giant cell tumor (TGCT).…
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd and its US partner ArriVent Biopharma Inc. have jointly released interim data from a Phase Ib trial at the 2023 World Conference on Lung Cancer (WCLC) meeting. The trial assessed the efficacy of furmonertinib as a treatment for non-small cell lung cancer (NSCLC), specifically…
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The European Medicines Agency (EMA) has accepted for review a filing made by the Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) for the tyrosine kinase inhibitor (TKI) Balversa (erdafitinib) as a treatment for locally advanced unresectable or metastatic urothelial carcinoma (UC) in adults with susceptible fibroblast growth factor…
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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 multi-center, randomized, double-blind Phase Ib/III clinical study. The study will assess the combination of dalpiciclib (SHR6390) with abiraterone plus prednisone in patients with metastatic hormone…
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US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed drug Keytruda (pembrolizumab) has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficient (dMMR) advanced solid tumors. This includes colorectal cancer patients who have…
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Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration for its next-generation autologous CAR-T therapy, IMC008, for the treatment of pancreatic cancer. This follows the company’s first ODD status granted for gastric cancer in the country less…
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for its Category 1 product, glumetinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET 14 exon mutation. Glumetinib’s Development and EfficacyCo-developed by Haihe Pharma and the Chinese Academy…
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Precision medicine specialist Lucence, with a presence in Suzhou, Hong Kong, and Palo Alto, California, has announced that the interim results of the LIQUIK study, a prospective international multicenter liquid biopsy study for lung cancer, will be reported at the IASLC 2023 World Conference on Lung Cancer (WCLC) held on…
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, trade-named Botawei, for the treatment of breast cancer in premenopausal and perimenopausal women eligible for hormone therapy. Botawei: A Pioneering Treatment for…
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Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ), has released an update on a late-stage study for its bispecific antibody (BsAb) Rybrevant (amivantamab). The study investigated the combination of Rybrevant with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy in treating advanced or metastatic non-small cell lung cancer (NSCLC)…
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CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for narlumosbart (JMT103), an anti-RANKL monoclonal antibody (mAb), to treat giant cell tumors of bone that are inoperable or may lead to severe…
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive advanced colorectal cancer, marking…
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China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its programmed cell death-1 (PD-1) monoclonal antibody (mAb) zimberelimab. The drug is indicated for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1…
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), and its partner Genmab (NASDAQ: GMAB), have announced the achievement of the primary endpoint in a Phase III trial for their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). The trial focuses on patients with recurrent or metastatic…
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, for review. The drug is intended for the treatment of HR+/HER2- advanced breast cancer in patients who have…
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Germany-based Bayer (ETR: BAYN) has announced that its subsidiary BlueRock Therapeutics’ open-label Phase I study for cell therapy bemdaneprocel in Parkinson’s disease has successfully met the safety and tolerability primary endpoint. After one year, no bemdaneprocel-related serious adverse events (SAEs) were reported. Additionally, dose-dependent improvement in motor symptoms and evidence…
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic…
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Switzerland-based pharmaceutical giant Roche (SWX: ROG) has released an update from an interim analysis of a late-stage trial for its ALK inhibitor Alecensa (alectinib) as adjuvant therapy in the early setting for resected non-small cell lung cancer (NSCLC) with ALK mutations. These mutations are present in approximately 5% of NSCLC…
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US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical Products Administration (NMPA) has approved an indication extension for its Verzenios (abemaciclib). The drug is now indicated as adjuvant therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and lymph…