Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.

Cstone Pharmaceuticals Co. Ltd. released positive data from the phase III trial, Gemstone-302, of sugemalimab plus chemotherapy for the first-line treatment of patients with stage IV squamous and non-squamous non-small cell lung cancer.

Eqrx Inc., a startup co-founded by serial biotech entrepreneur and investor Alexis Borisy to deliver new medicines for cancer and other conditions at "radically lower prices," is poised to raise up to $1.8 billion via a merger with the special purpose acquisition company (SPAC) CM Life Sciences III Inc. The transaction, which would bring Eqrx to Nasdaq, includes a fully committed and upsized PIPE of $1.2 billion led by Softbank Group's SB Management Ltd. as well as SPAC sponsors Casdin Capital LLC and Corvex Management LP, plus $550 million of cash and trust held by the SPAC itself.

In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy. The data built on positive data released in August from another phase III study showing sugemalimab (CS-1001) prolonged PFS when used as a first-line treatment for stage IV squamous and nonsquamous NSCLC plus standard-of-care chemotherapy, hitting the study’s primary endpoint.

In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy.

Now drugmakers can gain instant access to hospitals in Hainan province right after their innovative drugs are approved by China’s National Medical Products Administration to skip market entry hurdles.