Recent Articles in Trials & Approvals

Suzhou’s Innovent Biologics and HutchMed of Shanghai filed an NDA in China for a combination therapy aimed at advanced endometrial cancer. The trial tested Innovent’s sintilimab, an approved PD-1 immunoglobulin G4 mAb, and HutchMed’s fruquintinib, an approved VEGFR inhibitor. The NDA seeks China approval of the combination for advanced endometrial cancer company with pMMR[1] or non-MSI-H[2] tumors that have failed a prior systemic therapy. Patients must not be candidates for curative surgery or radiation. China’s National Medical Products Administration will review the application under Priority rules. More details....

Share this with colleagues:  

Taiwan’s PharmaEssentia reported positive data from studies of its ropeginterferon alfa-2b (BESREMi^®) therapy in patients with polycythemia vera (PV), a type of chronic leukemia (blood cancer) that causes bone marrow to overproduce red blood cells. The company said a 250–350–500 µg dosing regimen had the highest probability of a complete hematologic response with acceptable safety. The data was from an exposure–response analyses of the drug. PharmaEssentia published the results in the British Journal of Clinical Pharmacology. More details...

Share this with colleagues:

Zai Lab highlighted news that its partner Bristol Myers Squibb completed a pivotal Phase III trial showing Krazati® (adagrasib) was effective as a monotherapy in patients with NSCLC that harbors a KRASG12C mutation. Zai Lab added China data to the Phase III trial. In 2021, Zai Lab acquired China rights to adagrasib from Mirati Therapeutics in a $338 million ($60 million upfront) deal. Mirati was bought by BMS in 2023. Zai Lab expects to file an NDA in China later this year for adagrasib as a second or later line therapy in patients with KRASG12C mutated NSCLC. More details....

Share this with colleagues:  

Beijing InnoCare Pharma has dosed the first patient in a China Phase Ib trial of ICP-189, its SHP2 allosteric inhibitor, in combination with ArriVent’s furmonertinib to treat advanced or metastatic non-small cell lung cancer (NSCLC). Furmonertinib is an approved highly brain-penetrant EGFR inhibitor. ICP-189 is a novel selective oral allosteric inhibitor of SHP2 (Src homology 2 domain containing protein tyrosine phosphatase), a non-receptor protein tyrosine phosphatase that is usually expressed in the cytoplasm of several tissues. Innocare’s ICP-189 has shown preliminary efficacy as a monotherapy. More details....

Share this with colleagues:  

Sperogenix Therapeutics of Shanghai announced its NDA for Agamree (vamorolone), a treatment for Duchenne muscular dystrophy (DMD), has been accepted for review by China’s Center for Drug Evaluation (CDE). Two years ago, Sperogenix in-licensed greater China rights to the drug from Santhera Therapeutics of Switzerland in a $124 million agreement. A novel drug, Agamree binds to the same receptor as glucocorticoids but modifies its downstream activity for better safety. Sperogenix is a China rare disease company. More details....

Share this with colleagues: