NEWS

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Shots: Chinese NMPA received two IND applications for CT0596 to initiate P-Ib/II trials in r/r multiple myeloma (MM) & primary plasma cell leukemia (pPCL), respectively IIT in China showed favorable efficacy as of Aug 31, 2025, with 6/8 evaluable R/R MM pts achieving PR or better (3 CR/sCR, 1 VGPR, 2 PR) at an mFU…

December 29, 2025

Harbour BioMed Collaborates with Yantai Lannacheng Biotechnology to Develop Radionuclide Drug Conjugates (RDCs)

Shots: Harbour BioMed has entered into a long-term strategic collaboration with Yantai Lannacheng Biotechnology to jointly advance the development of next-generation RDCs Collaboration will combine Harbour’s fully human antibody discovery capabilities via its Harbour Mice platform with Lannacheng’s radiopharmaceutical R&D & commercialization strengths Harbour Mice platform provides fully human mAbs in both conventional & heavy chain-only…

December 29, 2025

ABL Bio Secures Upfront Payment and Equity Investment from Lilly to Accelerate Grabody Programs

Shots: ABL Bio has secured a total of $55M, incl. $40M upfront & $15M in equity investment, from Eli Lilly under their ~$2.602B license, research & collaboration agreement Under the deal, ABL Bio & Eli Lilly are jointly advancing multiple therapeutic candidates across diverse modalities, leveraging ABL Bio’s Grabody platform for collaborative research & development…

December 29, 2025

Bruno Vision Care Reports the US FDA Clearance of Deseyne for Presbyopia

Shots: FDA has cleared Deseyne, a daily disposable soft contact lens for presbyopia that uses patented Extended Depth of Focus technology Deseyne provides continuous near, intermediate, & distance vision through Cataltheia’s patented hyper-refractive central zone, showing a clinical advantage over multifocal lenses with minimal patient adaptation, strong comfort, & no adverse events reported in studies Made…

December 26, 2025

Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Shots: The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD) In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…

December 26, 2025

Sanofi and Regeneron’s Dupixent (Dupilumab) Receives MHLW Approval for Children with Bronchial Asthma

Shots: The MHLW has approved Sanofi and Regeneron’s Dupixent for the treatment of bronchial asthma in children (6-11yrs.) with severe or refractory disease whose symptoms are inadequately controlled with existing therapy Approval was based on the P-III (VOYAGE) trial data in the overall population & those with a type 2 inflammation phenotype, which showed reduced…

December 26, 2025

Italfarmaco and JCR Pharmaceuticals Partner to Commercialize Givinostat in Japan

Shots: Italfarmaco has entered into an exclusive licensing agreement with JCR Pharmaceuticals for the development and commercialisation of givinostat in Japan As per the deal, JCR will secure exclusive rights to commercialize givinostat, marketed as Duvyzat in US, EU & UK, for Duchenne muscular dystrophy (DMD) in Japan & will lead local execution of clinical…

December 26, 2025

Omeros Receives the FDA Approval for Yartemlea (Narsoplimab-wuug) to Treat TA-TMA

Shots: The US FDA has approved Yartemlea for the treatment of HSCT-Associated Thrombotic Microangiopathy, with US launch planned for Jan 2026. MAA is under the EMA’s review, with a decision expected in mid-2026 Approval was based on the TA-TMA Study (n=28) plus EAP (N=221 adults & pediatric pts), where 19 pts (13 adult & 6…

December 26, 2025

Innovent’s Tabosun (Ipilimumab N01) Receives the NMPA approval for MSI-H/dMMR Resectable Colon Cancer

Shots: The NMPA has approved Innovent's Tabosun (ipilimumab N01 injection or IBI310) + sintilimab for the neoadj. treatment of stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer Approval was based on the P-III (NeoShot) trial assessing ipilimumab N01 + sintilimab as neoadj. therapy in pts with MSI-H/dMMR colon cancer Trial met…

December 26, 2025

Gilead Sciences to Acquire Repare Therapeutics’ Polθ ATPase Inhibitor RP-3467 for ~$30M

Shots: Repare Therapeutics has entered into a definitive asset purchase agreement with Gilead Sciences for the acquisition of Repare's RP-3467, a polymerase theta (Polθ) ATPase inhibitor, strengthening Gilead’s precision oncology pipeline Under the Agreement, Repare will receive up to $30M in total consideration, including $25M upfront (subject to customary adjustments) and an additional $5M upon…

December 25, 2025

NEWS

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Harbour BioMed Collaborates with Yantai Lannacheng Biotechnology to Develop Radionuclide Drug Conjugates (RDCs)

ABL Bio Secures Upfront Payment and Equity Investment from Lilly to Accelerate Grabody Programs

Bruno Vision Care Reports the US FDA Clearance of Deseyne for Presbyopia

Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Sanofi and Regeneron’s Dupixent (Dupilumab) Receives MHLW Approval for Children with Bronchial Asthma

Italfarmaco and JCR Pharmaceuticals Partner to Commercialize Givinostat in Japan

Omeros Receives the FDA Approval for Yartemlea (Narsoplimab-wuug) to Treat TA-TMA

Innovent’s Tabosun (Ipilimumab N01) Receives the NMPA approval for MSI-H/dMMR Resectable Colon Cancer

Gilead Sciences to Acquire Repare Therapeutics’ Polθ ATPase Inhibitor RP-3467 for ~$30M

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