China NMPA Approved Penpulimab for First-line Treatment of Locally Advanced or Metastatic Squamous NSCLC

HONG KONG, Jan. 16, 2023 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso"), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, announced that the anti PD-1 monoclonal antibody drug penpulimab, co-developed by the Company with Sino Biopharmaceutical Limited (1177.HK) (together with its subsidiaries ''Sino Biopharm''), combined with chemotherapy as the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC) has been granted marketing approval by the National Medical Products Administration (NMPA) of China.

The approval of new indication is based on a randomized, double-blind, multi-center phase III clinical trial (AK105-302, NCT03866993), with 350 locally advanced or metastatic sq-NSCLC patients who have not received prior systemic therapy. According to the trial results published on 2022 ESMO Immuno-Oncology, penpulimab combined with chemotherapy shows consistent efficacy benefits across all efficacy endpoints and significantly reduces the risk of disease progression and death.

• The median progression-free survival (mPFS) of the treatment group (7.6 months) is significantly superior to the placebo+chemo group (4.2 months).
• The objective response rate (ORR) of the treatment group (71.4%) is significantly higher than the placebo+chemo group (44%).

In terms of safety, the treatment group shows no difference in the incidence of adverse event (AE) and serious adverse event (SAE), which shows the favourable safety profile of penpulimab.

Lung cancer is a malignant tumor with high incidence and high mortality rate worldwide. The incidences of lung cancer around the world and in China have exceeded 2.2 million and 810 thousand respectively in 2020. NSCLC patients accounts for 85% of total lung cancer patients, and about 30% of NSCLC patients are sq-NSCLC. The NMPA's approval of penpulimab combined with chemotherapy as the first line treatment of locally advanced or metastatic sq-NSCLC will further expand its potential.

In April 2022, this therapy was included as Grade II recommendation in Guidelines for Non-Small Cell Lung Cancer Treatment (2022) of Chinese Society of Clinical Oncology (CSCO) and was included in Guidelines of Chinese Society of Clinical Oncology Immune Checkpoint Inhibitor Clinical Practice (2022).

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