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Amgen
NEWS

Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC

Shots: The MHRA has granted conditional marketing authorization to Imdylltra for treating adults with ES-SCLC, whose disease progressed post prior 2 lines of treatment. Further evaluation is underway This authorization was supported by P-II (DeLLphi-301) study assessing Imdylltra (10mg, Q2W) in ES-SCLC patients (N=99). It showed ORR of 41% & mDoR of 9.7mos. …
January 6, 2025

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Astellas
NEWS

Astellas’ Vyloy (Zolbetuximab) Secures the NMPA’s Approval as a 1L Treatment of Advanced G/GEJ Adenocarcinoma

Shots: The NMPA has granted approval to Vyloy + fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic HER2-, CLDN18.2+ G/GEJ adenocarcinoma Approval was supported by P-III (GLOW: n=145 & SPOTLIGHT: n=36) studies assessing Vyloy + CAPOX & mFOLFOX6, respectively, vs PBO among Chinese patients with this indication …
January 6, 2025

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GSK
NEWS

GSK’s Nucala (Mepolizumab) Secures the NMPA’s Approval for Treating Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The NMPA has approved Nucala as an add-on therapy with intranasal corticosteroids in CRSwNP adults with inadequately controlled disease. It is approved for patients (≥12yrs.) as an add-on treatment of severe eosinophilic asthma & for adults having eosinophilic granulomatosis with polyangiitis Approval was based on 2 P-III studies: MERIT assessing Nucala vs PBO…
January 3, 2025

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Innovent
NEWS

Innovent Reports the NMPA’s Approval of Dovbleron (Taletrectinib Adipate Capsule) for Treating ROS1-Positive NSCLC

Shots: The NMPA has approved another NDA of Dovbleron (ROS1 tyrosine kinase inhibitor) for treating locally advanced or metastatic ROS1+ NSCLC. It was approved for those with ROS1+ NSCLC previously treated with ROS1 TKIs in Dec 2024 The approval was supported by pivotal P-II (TRUST-I) study assessing safety, tolerability and efficacy of Dovbleron to…
January 3, 2025

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Hutchmed
NEWS

HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification

Shots: The NMPA has accepted and granted priority review to NDA of Orpathys (savolitinib) + Tagrisso (osimertinib) for treating locally advanced or metastatic EGFR-mutated NSCLC with MET amplification in patients progressed on 1L EGFR inhibitor therapy. HUTCHMED will receive milestone from AstraZeneca Submission was based on P-III (SACHI) study assessing the safety & efficacy…
January 2, 2025

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Takeda
NEWS

Takeda’s ADAMTS13 Receives the CHMP’s Positive Opinion for Congenital Thrombotic Thrombocytopenic Purpura (cTTP) 

Shots:  The CHMP has granted a positive opinion to ADAMTS13 (rADAMTS13) for treating ADAMTS13 deficiency in cTTP children and adults   The positive opinion was based on the P-III study assessing the efficacy, PK, safety, and tolerability for the same. Data was published in The New England Journal of Medicine in May 2024  rADAMTS13 is a…
May 31, 2024

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NEWS

Alvotech Collaborates with Dr. Reddy’s to Commercialize AVT03 (Biosimilar, Prolia & Xgeva) 

  Shots:  Alvotech & Dr. Reddy’s have signed a license & supply agreement to commercialize AVT03 under which Alvotech will handle the development & manufacturing activities. Dr. Reddy will get regulatory & commercial rights exclusively in US and semi-exclusively in the EU & UK   Alvotech will receive an upfront, regulatory & commercial milestones as well as…
May 21, 2024

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NEWS

Boehringer Ingelheim Partners with Quallent Pharmaceuticals to Expand the Access of Cyltezo (Biosimilar, Humira) 

Shots:  Boehringer Ingelheim has signed an agreement with Quallent Pharmaceuticals to expand the access of citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), across the US  As per the agreement, BI will handle the manufacturing activity of adalimumab-adbm for Quallent and will continue the commercialization of Cyltezo (adalimumab-adbm) injection and Adalimumab-adbm  Quallent will provide high-concentration (40mg/0.4mL)…
May 13, 2024

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