Cancer drug 1st in China OK'd for third-party contracting

The approval of the innovative cancer treatment tislelizumab by Chinese authorities marked a key milestone in the application of the Marketing Authorization Holder (MAH) system in China, industry people said.

The China National Medical Products Administration announced on Saturday that the Chinese pharmaceutical company BeiGene Ltd's anti-PD-1 antibody tislelizumab had received its approval as a treatment for patients with classical Hodgkin's lymphoma who have received at least two prior therapies under priority review.

Anti-PD-1 antibodies are novel immunotherapies that help the immune system to target and kill tumors, and tislelizumab is BeiGene's first drug approved in China.

John V Oyler, chairman, co-founder and CEO of BeiGene, said the company looks forward to the newly approved drug's further development in a broad array of solid tumors and hematological malignancies.

The drug is also the first innovative biologic approved in China to be produced by a Marketing Authorization Holder under the contract manufacturing regulatory system after the revision of the drug authorization law that took effect on Dec 1 and adopted the MAH system.

Under the new law, individuals and entities who have become medicine MAHs shall be responsible for the full "life cycle" of the drugs, including clinical and nonclinical trials, manufacturing, selling, and the analysis, report and response of adverse reactions, and can engage contract manufacturers for the manufacturing of the drugs.

That marks the separation of drug production authorization from marketing authorization in China, allowing drug research institutes and individual researchers to become drug registration applicants, and to authorize third-party entities to commercially manufacture drug products as marketing authorization holders.

Based on the cooperation agreement between BeiGene and Boehringer Ingelheim Biopharmaceuticals China, the latter will provide long-term commercial contract manufacturing services for the drug, making it the first company to successfully provide biopharmaceutical contract manufacturing services in line with the revised drug administration law.

"The approval of the new immuno-oncology drug marks the successful application of the revised drug administration law," said Wu Xiaobin, president of BeiGene.

The new drug is expected to benefit cancer patients in China and around the world, and BeiGene's collaboration with Boehringer Ingelheim Biopharmaceuticals China will not only ensure the high-quality production and stable supply of this new biologic, but also support clinical trials of the drug in other types of cancer, he said.

The MAH system will further foster the rapid rise of the biopharmaceutical industry in China, and bolster the significant growth of life sciences research in China, he added.

Luo Jiali, general manager and site head of Boehringer Ingelheim Biopharmaceuticals China, said his company got involved in a pilot reform program on the MAH system in China as early as in 2016, and the new officially established MAH system model can be of great benefit for Chinese healthcare systems and will finally provide Chinese patients broader access to more innovative drugs.