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EMA Reviews Janssen’s Balversa for Advanced Urothelial Carcinoma with FGFR3 Alterations
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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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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
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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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Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
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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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Immunofoco’s IMC008 Earns Orphan Drug Designation for Pancreatic Cancer from FDA
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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’s Glumetinib Filed for Marketing in Japan for NSCLC Treatment
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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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LIQUIK Study Interim Results to Showcase Lucence’s Liquid Biopsy Advancements at WCLC 2023
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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’s Botawei Receives NMPA Approval for Breast Cancer Treatment
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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’s Rybrevant Combo Meets Primary Endpoint in Advanced NSCLC Study
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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’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
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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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Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
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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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Harbin Gloria Pharmaceuticals’ Zimberelimab Receives NMPA Approval for Cervical Cancer Treatment
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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 and Genmab Announce Positive Phase III Results for Tivdak in Cervical Cancer
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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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Sihuan Pharmaceutical’s Birociclib NDA Accepted for Review by China’s NMPA
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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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Bayer Subsidiary’s Parkinson’s Treatment Bemdaneprocel Shows Promise in Phase I
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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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AstraZeneca’s Calquence Approved by NMPA for Chronic Lymphocytic Leukemia Treatment
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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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Roche’s Alecensa Achieves Milestone in Adjuvant Therapy Trial for Early-Stage NSCLC
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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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Eli Lilly’s Verzenios Receives NMPA Approval for Extended Indication in Early-Stage Breast Cancer
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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…
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XtalPi Partners with Parthenon Therapeutics to Harness AI for Solid Tumor Antibody Development
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Sino-US artificial intelligence (AI) firm XtalPi (QuantumPharm, HKG: 2228) has entered into a strategic partnership with US cancer therapy developer Parthenon Therapeutics Inc. to develop antibodies targeting solid tumors. This collaboration aims to leverage the power of AI to advance oncology treatments. Access to XtalPi’s XupremAb Platform and “Experiment+AI” SolutionsUnder…
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Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
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The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB, HKG: 9688) Margenza (margetuximab), an Fc-engineered monoclonal antibody (mAb) targeting HER2 and developed by MacroGenics Inc., has been approved for the China market. The drug is indicated for the treatment of metastatic HER2-positive breast cancer…
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Servier Group’s Pancreatic Cancer Therapy Onivyde Launches in Major Chinese Cities
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France-based Servier has announced the first prescriptions for its pancreatic cancer therapy, Onivyde (irinotecan), in 10 hospitals across major cities in China, including Tianjin, Beijing, Shanghai, Nanjing, Fuzhou, and Guangzhou. The drug is used to treat metastatic pancreatic cancer after gemcitabine treatment, in combination with 5-fluorouracil (5-FU) plus leucovorin (LV).…
