Beijing News (Reporter Zhang Xiulan) On the evening of March 24, Innovent announced that it had received the US Food and Drug Administration (FDA) for the use of sintilimab in combination with pemetrexed and platinum-based chemotherapy. A complete response letter to a New Drug Application (BLA) for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), which the FDA failed to approve. Previously, the products of BeiGene and Legend Bio have been approved by the FDA in China and successfully “going overseas”.
It is recommended to supplement additional clinical trials
The drug sintilimab applied for marketing this time, Co-developed and commercialized PD-1 monoclonal antibody drug for Innovent Biologics and Eli Lilly. Sintilimab was approved for marketing in China on December 24, 2018, and a marketing application was submitted to the FDA in March 2021. The declared indication is sintilimab combined with pemetrexed and platinum for non-squamous non-squamous First-line treatment of small cell lung cancer.
Before receiving the complete reply letter from the FDA this time, the road of sintilimab to “break through” has already achieved phased results. On February 11 this year, the results of the discussion at the FDA Oncology Drug Advisory Committee Review Meeting (ODAC) were released, suggesting that Innovent Biologics should supplement additional clinical trials to demonstrate the applicability of sintilimab in the U.S. population and U.S. medical practice. At that time, the marketing application submitted by Innovent was mainly based on the ORIENT-11 Phase III clinical trial data in China. ORIENT-11 is a high-quality, high-standard, Chinese clinical trial involving experienced clinical investigators and meeting the requirements of the globally certified GCP. The trial results data show that sintilimab has a good risk-benefit relationship.
In its response letter, the FDA also recommended that sindixumab combined with chemotherapy and standard therapy for first-line metastatic NSCLC should be non-inferior in multiple regions with overall survival as the endpoint. Sexual clinical trials. Innovent said that it is evaluating the next steps of Sindica in the United States with Eli Lilly.
On February 4th this year, the latest information released by Innovent Biotech showed that Daboshu achieved revenue of 900 million yuan in the fourth quarter of 2021, and sales continued to grow quarter by quarter. . After the market opened on March 25, Innovent’s share price fell, down 5.05% so far, with a share price of HK$30.10 per share.
Innovative power of local enterprises is gradually improving
Innovent is not the only one who has failed the FDA road. In April 2021, Kanghong Pharmaceutical suspended the international phase III clinical trial of its blockbuster product Conbercept, and its stock price suffered a continuous decline. Ke Zunhong, chairman of Kanghong Pharmaceuticals, said at the annual shareholders meeting that the termination of the trial was “a tuition fee” for Kanghong Pharmaceuticals.
Up to now, a total of two domestic companies’ drugs have been successfully approved by the FDA.
In November 2019, the FDA approved the new anti-cancer drug “zanubrutinib” independently developed by BeiGene. “Approved for listing, this is also the first new anti-cancer drug that was completely independently developed by a Chinese company and approved for marketing by the FDA; in February this year, the cell therapy product Sidaki Aurexa, a cell therapy product independently developed by GenScript’s subsidiary Legend Bio, was approved by the FDA. It became the first FDA-approved cell therapy product in China.
With the gradual improvement of the innovation capabilities of local enterprises, domestic innovative drugs continue to work hard for “going overseas”. In March 2021, Junshi Bio submitted a new drug application for toripalimab to the FDA, which was accepted by the FDA. In May of that year, Kangfang Bio also submitted a new drug marketing application for Papilimumab to the FDA, and the declared indication was the third-line treatment of metastatic nasopharyngeal carcinoma. PD-1 drugs under review under the RTOR project. In September 2021, BeiGene’s marketing application for tislelizumab was accepted by the FDA, and the indication is unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma after systemic therapy. This is the target date for the FDA to make a decision on the tislelizumab marketing application. Another traditional Chinese medicine product, Lianhua Qingwen Capsule, was approved to enter the FDA Phase II clinical study in December 2015.
Proofreading Liu Baoqing