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Janssen Submits Indication Extension Application for Balversa in Urothelial Carcinoma Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an indication extension application to the US Food and Drug Administration (FDA) for its FGFR kinase inhibitor Balversa (erdafitinib). The application seeks to expand the use of Balversa as a treatment for locally advanced or metastatic urothelial carcinoma…
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Antengene’s Xpovio Price Reduced by 37% in China, Aiding Patient Access
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Antengene Corp., Ltd (HKG: 6996) has announced a significant price reduction for its drug Xpovio (selinexor) in China, cutting the cost by 37%. The new pricing for the 20mg*12 tablet box is RMB 14,135, and for the 20mg*16 tablet/box, it is RMB 18,649.67, down from the previous prices of RMB…
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GenFleet Therapeutics and Verastem Oncology Ink Licensing Deal for RAS Pathway Cancer Therapies
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China-based GenFleet Therapeutics has entered into an exclusive licensing and early development agreement with US firm Verastem Oncology (NASDAQ: VSTM). Under the agreement, Verastem will obtain development and commercialization rights to GenFleet’s three oncology discovery programs targeting RAS pathway-driven cancers, excluding Greater China. Financial Terms and Potential Deal SizeThe agreement…
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Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review with the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Rybrevant (amivantamab). The submission seeks approval for Rybrevant in combination with carboplatin and pemetrexed as a first-line treatment for locally advanced or…
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Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its third-generation antibody drug conjugate (ADC), STRO-002, in advanced malignant solid tumors. STRO-002: A Third-Generation ADC Targeting FRαSTRO-002, originated by US firm Sutro Biopharma Inc.,…
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AstraZeneca and MSD’s Lynparza Gets Green Light for Prostate Cancer Treatment in Japan
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Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca (AZ; NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for the use of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a treatment for BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant…
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Akeso Biopharma’s Ivonescimab Heads for Priority Review for NSCLC Treatment
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China-based Akeso Biopharma (HKG: 9926) has announced that its bispecific antibody (BsAb) ivonescimab (AK112), targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), is on course for priority review for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations that progress after treatment…
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Dizal Pharmaceutical’s Sunvozertinib Approved by China’s NMPA for NSCLC Treatment
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This novel targeted therapy is now approved for the treatment of locally advanced or metastatic non-small cell lung…
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Hinova Pharmaceuticals’ HP518 for mCRPC Accepted for Review by China’s NMPA
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Chengdu-based biotech company Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the National Medical Products Administration (NMPA) has accepted its clinical filing for HP518, a Category 1 chemical drug intended to treat metastatic castration-resistant prostate cancer (mCRPC). HP518: A Promising PROTAC Drug for Prostate CancerHP518 is an androgen receptor (AR)…
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Eli Lilly’s Retevmo Meets Primary Endpoint in Phase III Trial for RET-mutant Medullary Thyroid Cancer
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Eli Lilly (NYSE: LLY) has announced that its Phase III trial for the RET kinase inhibitor Retevmo (selpercatinib) has successfully met its primary endpoint in patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC). The trial demonstrated a significant improvement in progression-free survival (PFS) compared to cabozantinib or vandetanib,…
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FDA Grants Priority Review to Pfizer and Astellas’ Xtandi for High-Risk Prostate Cancer
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The US Food and Drug Administration (FDA) has granted priority review status to the submission by pharmaceutical partners Pfizer (NYSE: PFE) and Astellas (TYO: 4503) for their drug combination of Xtandi (enzalutamide) and leuprolide. This treatment is intended for patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) who are at high…
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Allist Pharmaceuticals’ Furmonertinib Wins NMPA Nod for EGFR-Mutated NSCLC Treatment
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its drug furmonertinib. The drug is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR PACC mutation or EGFR L861Q…
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Zai Lab’s Repotrectinib Targets Breakthrough Therapy Designation for TRK-Positive Tumors
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The Center for Drug Evaluation (CDE) website has indicated that repotrectinib, a next-generation ROS1/TRK/ALK tyrosine kinase inhibitor (TKI) licensed by China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB), is on track to receive breakthrough therapy designation (BTD) status in China for the treatment of NTRK fusion-positive advanced solid tumors that…
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Roche Subsidiary Genentech Addresses Accidental Disclosure of Tiragolumab Trial Data
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Swiss pharmaceutical major Roche (SWX: ROG), through its subsidiary Genentech, has released a statement addressing an accidental disclosure of the second interim analysis from an ongoing Phase III study. The study involves the anti-TIGIT biologic tiragolumab, used with and without the PD-L1 inhibitor Tecentriq (atezolizumab), for patients with PD-L1-high locally…
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European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
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The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, for its innovative GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This first-in-class treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have shown disease progression after at least three prior…
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Novatim’s KQ-2003 and KY-0118 Advance with Clinical Trial Approvals in China
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China-based cancer immunotherapy specialist Novatim Immune Therapeutics (Zhejiang) Co., Ltd has recently obtained clinical trial clearances for two of its products in China. The products are KQ-2003, an autologous chimeric antigen receptor (CAR) T cell therapy for the fourth-line treatment of recurrent/refractory multiple myeloma, and KY-0118, a therapy aimed at…
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Lifetech Scientific Corporation Receives NMPA Approval for Epione Navigation System
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its product, Epione. Epione is an in-licensed puncture surgery navigation and positioning system designed for navigation and positioning in adult abdominal solid organ puncture surgery. Origin and Commercialization…
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Gilead’s Magrolimab Phase III Trial for AML Faces Partial Hold by FDA
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Gilead (NASDAQ: GILD) has announced that the US Food and Drug Administration (FDA) has imposed a partial hold on recruitment for a Phase III trial of its investigational anti-CD47 biologic, magrolimab, in acute myeloid leukemia (AML). The company has not disclosed the reason behind the FDA’s decision but has indicated…
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J&J’s Teclistamab Granted Priority Review in China for Relapsed Multiple Myeloma
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson’s (J&J, NYSE: JNJ) teclistamab has been granted priority review for the treatment of recurrent or refractory multiple myeloma in China. The drug is being considered for conditional approval due to its breakthrough therapy designation (BTD) status, given…
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Amgen’s Lumakras Faces Full Registration Review by FDA for KRAS-Mutated NSCLC
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The US Food and Drug Administration (FDA) is scheduled to review an application submitted by Amgen (NASDAQ: AMGN) for the full registration of its pioneering KRASG12C inhibitor, Lumakras (sotorasib), in October this year. The treatment targets locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). Amgen announced this…
