The BIOCAD and Shanghai Pharmaceuticals Holding joint venture has announced the enrollment of the first Chinese patient in the Phase III international multicenter clinical trial of +prolgolimab. BCD-100-3/DOMAJOR is an international clinical trial of an original anti-PD1 check point inhibitor in patients with non-small cell lung cancer (NSCLC) by BIOCAD. The clinical trial in China is conducted by SPH-Biocad (HK) Ltd., the co-sponsor of the international prolgolimab clinical research program. The drug is expected to be available to Chinese patients as early as 2026.
The clinical trial in China was approved by the CDE of NMPA this February, and the final permission of the Human Genetic Resource Administration of China (HGRAC) was obtained in July. The completion of the clinical trial is planned for the second half of 2025, which will allow the drug to be launched on the Chinese market in 2026.
BIOCAD CEO Dmitry Morozov stated,
The Chinese market is very important for us for many reasons, primarily because of the efforts of the Chinese authorities to update and modernize the healthcare system. Assistance programs offered to citizens of the country for the treatment of cancer provide great opportunities for knowledge-intensive businesses around the world. It is also very important to us that this is our first experience of integrating the company’s products in China, and we are grateful to our Chinese partner Shanghai Pharmaceuticals Holding for their well-coordinated efforts and sincere interest in cooperation. I hope for the future expansion of this partnership and that it will not just be limited to the sale of pharmaceuticals.
The BCD-100-3/DOMAJOR clinical trial is also simultaneously taking place in the European Union and Russia. It is an international multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of BCD-100 in combination with pemetrexed + cisplatin/carboplatin versus placebo in combination with pemetrexed + cisplatin/carboplatin as the first-line therapy for patients with non-small cell lung cancer. It is planned that the study will involve 88 patients from China diagnosed with lung cancer (NSCLC). At the end of the study, a dossier will be submitted for obtaining a marketing authorization for prolgolimab in the People’s Republic of China.
BCD-100-5 / FERMATA is another prolgolimab clinical trial planned to be conducted in patients with cervical cancer in China. At least $20 million will be invested in these two prolgolimab studies. The total investment (including investment from partners) in international multicenter clinical trials (MMCI) of prolgolimab will reach over $35 million.
Prolgolimab is a monoclonal antibody that binds the PD-1 programmed cell death receptor and blocks its interaction with PD-L1 and PD-L2 ligands. Prolgolimab is an immunoglobulin. The Fc fragment of prolgolimab has been modified to prevent cytotoxic effects on target cells expressing PD-1. In Russia, prolgolimab is included in the list of List of Vital and Essential Medicines.
An increase in the number of studies of PD1/PDL1 inhibitors and their various combinations has been recorded in China, and the market itself demonstrates a significant demand for such inhibitors. Chinese experts forecast the PD1/PDL1 inhibitor market to reach over 30 billion ($4.7 billion) yuan annually over the next five years. Thanks to the assistance programs in the country, Chinese patients pay a small part of the cost of drugs for cancer therapy with a large share of the costs covered by the national health insurance fund of China that holds more than 2.44 trillion yuan ($373 billion) and covers 95% of the country’s residents.