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On January 22, 2025,《Nature Medicine》 published the results of the Akeso independently developed PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine for the first-line treatment of unresectable locally advanced or metastatic gastric or gastroesophageal j...Read more »
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On January 8, 2025,China’s National Medical Products Administration (NMPA) has approved PADCEVTM (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC). The NMPA’s approval of enfortumab vedotin in comb...Read more »
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On February 17, 2025,Innovent Biologics announced that its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, has received its second Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). This designation applies to the treatment of unresectable, ...Read more »
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On January 16, 2025, IMPACT announce that Senaparib Capsules (派舒宁®)has received marketing authorization in China from National Medical Products Administration (NMPA) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ov...Read more »
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On February 7, 2025,Sichuan Kelun-Biotech Biopharmaceutical announced the approval of its Cetuximab N01 Injection by the National Medical Products Administration for the treatment of metastatic colorectal cancer (mCRC) in China. The approval is based on a large-scale phase III clinical study sho...Read more »
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On February 10, 2025,CARsgen Therapeutics announces that the first subject treated with an allogeneic BCMA CAR-T therapy developed on the THANK-u Plus™ platform, has achieved stringent complete response (sCR) and minimal residual disease (MRD) negativity at the Day-28 assessment.Developed in-hous...Read more »
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On January 29, 2025, a Chinese research team published an article titled “Neoadjuvant pyrotinib and trastuzumab in HER2 positive breast cancer with no early response (NeoPaTHer): effectiveness, safety, and biomarker analysis of a prospective, multicenter, response adapted study” in th...Read more »
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On January 26, 2025, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that LM-108 injection is intended to be included in breakthrough therapy for advanced solid tumors with microsatellite instability (MSI-H) or mismatch repair defects (dMMR) th...Read more »
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On January 20th,The National Medical Products Administration (NMPA) approves the innovative humanized monoclonal antibody tagitanlimab (formerly KL-A167) Combination therapy of cisplatin and gemcitabine for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) patients. ...Read more »
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On January 16, 2025, China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). About Limertinib Limertinib ...Read more »
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On January 8th, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343, a potentially best-in-class TOPO1i anti-CLDN18.2 ADC, as monotherapy for the treatment of CLDN18.2-positive advanced pancr...Read more »
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On January 8, 2025, 9MW2821 was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.9MW2821 is given in combination with toripalimab, an anti-PD-1 monoclonal antibody, for treatment-naïve, unresecta...Read more »