Officially cut into the CAR-T track! Huadong Medicine obtained the commercialization rights of Zewoki Orencel injection, a CAR-T product of Keji Pharmaceutical

On January 16, 2023, Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Huadong Pharmaceutical", stock code: SZ.000963) announced that Huadong Pharmaceutical (Hangzhou) Co., Ltd., a wholly-owned subsidiary of the Company, and Kaixing Life Science (Shanghai) Co., Ltd., a wholly-owned subsidiary of Keji Pharmaceutical, signed an exclusive product commercialization cooperation agreement to obtain Kaixing Life for the treatment of relapse/ Exclusive commercialization rights to Zewaki Orencel Chinese mainland injection for the fully human anti-autologous BCMACAR-T candidate for refractory multiple myeloma.

Huadong Pharmaceutical (Hangzhou) will make an initial payment of RMB200 million and a registration and sales milestone payment of up to RMB1.025 billion.

Huadong Medicine said that as a product with great potential, Zewoki Orencel injection will further enrich the company's product line in the field of blood diseases, and will share expert networks, research and clinical resources with the company's existing key varieties in this field in terms of marketing to form an effective synergy.

According to the announcement, zevorcabtagene autoleucel injection (R&D code: CT053) is a fully human anti-autologous BCMA (B cell mature antigen) CAR-T (chimeric antigen receptor T cell) product for the treatment of relapsed/refractory multiple myeloma (R/RMM), which was awarded the title of Regenerative Medicine Advanced Therapy (RMAT) and orphan drug by the US FDA in 2019. In 2019 and 2020, it was awarded the title of Priority Drug (PRIME) and Orphan Drug Product by the European Medicines Agency (EMA). Zewauki Orencel injection also received a breakthrough therapy drug variety from the State Food and Drug Administration in 2020.

There is still a huge demand gap for multiple myeloma (MM, MultipleMyeloma) treatment. Multiple myeloma is a fatal hematologic malignancy in which plasma cells in the bone marrow grow out of control and produce abnormal proteins that can cause damage to vital organs including the heart and kidneys. At present, there is no cure for the disease, and almost all patients will eventually relapse, with a 5-year recurrence rate of nearly 70%. Also, patients who currently relapse under conventional therapy have a poor prognosis and few treatment options. Therefore, these patients have a huge unmet clinical need and urgently need an effective, safe and convenient treatment. Clinical trial data show that CAR-T cells significantly improve the efficacy of tumor treatment, bring the possibility of cure for tumor patients, and improve the quality of life of patients, and are becoming the treatment choice of more and more tumor patients.

Zewaukee Orencel injection has shown good clinical treatment results in the treatment of relapsed/refractory multiple myeloma. In December 2021, CARsgen presented the results of the Phase I clinical trial of LUMMICARSTUDY1 conducted in China by Zewauki Orscel Injection at the American Society of Hematology ("ASH") Annual Meeting. IN OCTOBER 2022, BASED ON DATA FROM AN OPEN-LABEL, SINGLE-ARM PHASE I/II CLINICAL TRIAL (LUMMICARSTUDY1) CONDUCTED IN CHINA, THE MARKETING AUTHORIZATION APPLICATION FOR ZEWOKI ORENCEL INJECTION WAS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) AND INCLUDED IN THE PRIORITY REVIEW AND APPROVAL PROCESS. At present, no similar products have been approved in China.

In December 2022, preliminary data from the pivotal phase II study of LUMMICARSTUDY1 were presented at the 2022 American Society of Hematology Annual Meeting. The results of the study showed that as of August 16, 2022, the median follow-up of 102 patients was 9 months (range 0.4-17.8 months), the ORR was 92.2% (95% CI, 85.13, 96.55), the rate of response of VGPR and above was 85.3%, and the rate of CR/sCR was 45.1%. The results of the study showed that Zewauki orencel injection has a good safety and efficacy. Zewauki orencel injection is also a promising treatment for patients with high-risk factors.

The number of patients with multiple myeloma will further grow in the future, and the treatment market has broad prospects. According to the World Health Organization, in 2020, there were about 113,000 cases of multiple myeloma (newly diagnosed and relapsed/refractory patients) in China. According to Huaan Securities Research Report, the market size of multiple myeloma-related therapeutic drugs in China is expected to further grow to 2.4 billion yuan by 2025.

Multiple myeloma is the second largest malignant blood disease in the world, and Huadong Medicine's core products in the field of blood diseases include cyclosporine soft capsules, mycophenolate mofetil capsules/dispersible tablets, tacrolimus capsules, decitabine for injection, sirolimus oral liquid, etc.

The co-operation of East China Pharma is a biopharmaceutical company with operations in China and the United States, mainly focusing on innovative CAR-T cell therapy for the treatment of hematologic malignancies and solid tumors. CARsgen has established an integrated cell therapy platform and has internally developed a number of new technologies and a product pipeline with global interests. Keji Pharmaceutical has taken the lead in establishing independent and vertically integrated production capacity among similar companies in China, built a commercial production plant in Jinshan District, Shanghai, and obtained China's first drug production license for CAR-T cell therapy. At the same time, CARsgen also plans to conduct other clinical trials to develop Zewauki orencel injection as an early treatment for multiple myeloma.

The field of oncology is one of the three core therapeutic areas of East China Medicine in the pharmaceutical industry. In recent years, Huadong Medicine has continuously carried out in-depth layout in the field of oncology, and has successively cooperated with many foreign innovative R&D enterprises such as ImmunoGen, Kiniksa, HeidelbergPharma and introduced innovative technologies and products.