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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).…
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Takeda Secures Exclusive Rights to ImmunoGen’s Elahere in Japan Through New Agreement
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Japanese pharmaceutical company Takeda (TYO: 4502) has entered into an exclusive collaboration and license agreement with ImmunoGen (NASDAQ: IMGN) to develop and commercialize ImmunoGen’s antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) in Japan. Elahere has received accelerated approval in the United States for the treatment of FRα-positive platinum-resistant epithelial ovarian, fallopian…
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Dizal Pharmaceutical’s Golidocitinib Earns Priority Review for r/r PTCL Treatment in China
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its drug golidocitinib has been included in the priority review list for the treatment of recurrent or refractory peripheral T-cell lymphoma (r/r PTCL) in patients who have received at least one standard treatment. The priority status indicates the drug’s filing…
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Biocytogen Pharmaceuticals’ Eucure Biopharma Expands Partnership with Syncromune on Immunotherapies
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd’s (HKG: 2315) wholly owned subsidiary, Eucure Biopharma, has announced a technology transfer agreement with US firm Syncromune. This agreement builds upon an earlier licensing deal made in 2022, which resulted in Eucure transferring rights related to the drug candidate YH002 and other clinical stage…
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Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
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Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC) for an indication extension of its SMN2 splicing modifier Evrysdi (risdiplam). The drug is now approved for infants up to 2 months of age with a clinical diagnosis of spinal muscular atrophy (SMA) type 1,…
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BMS’ Reblozyl Expands Indication to Include First-Line MDS-Related Anemia Treatment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has received an indication extension approval from the US Food and Drug Administration (FDA) for its first-in-class drug Reblozyl (luspatercept). The drug is now approved as a first-line treatment for low- to intermediate-risk myelodysplastic syndromes (MDS)-related anemia in adults who may require regular red blood…
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ImmunoTech Biopharm’s EAL Earns Breakthrough Therapy Designation for HCC Recurrence Prevention
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The Center for Drug Evaluation (CDE) in China has indicated on its website that Immunotech Biopharm Ltd, a specialist in chimeric antigen receptor T-cell (CAR-T) therapies, has received breakthrough therapy designation (BTD) status for its EAL (amplified activated lymphocytes) product. This designation recognizes EAL’s potential use in the prevention of…
