Dark horse! The first company in China to get clinical approval for cellular immunotherapy drugs

With the approval of CAR-T products of Novartis and Kite Pharmaceuticals and the clear regulatory path of cell therapy in China, CAR-T has become a hot area in the industry and investment circles. The valuation of domestic CAR-T companies has soared rapidly. Not only have several companies received huge amounts of financing, but also attracted the cooperation of international pharmaceutical giants.

However, from the perspective of the whole cell therapy field, the cell therapy products that are the first to declare according to the form of drugs and obtain clinical approval in China are not in the CAR-T field, but two products called "autologous ovarian cancer cytotoxic T lymphocyte injection" and "amplified and activated lymphocytes" respectively, which were approved for clinical use on March 11, 2015 and October 26, 2017, the company that developed the above products is a dark horse company that has been ignored by the investment community-Yongtai Bio.

Up to now, there are 16 cell therapy products in China to declare clinical according to drugs. Yongtai Bio is the first company in China to obtain clinical approval documents for cellular immunotherapy drugs, and it is also the only company in China that has two clinical approval documents for adoptive cellular immunotherapy at the same time, which has obvious first-mover advantage.

The newly approved amplified activated lymphocytes (Expanded Activated Lymphocytes,EAL) product of Yongtai Bio is introduced as an example. EAL technology is prepared from the patient's own peripheral blood mononuclear cells, the main component is the expansion of activated lymphocytes, CD8 killer T lymphocytes (surface marker CD3 molecules) as the main active ingredient. After one or more reinfusion, it is used for adjuvant treatment of malignant tumors and chronic infectious viral infections. Since its establishment in 2006, Yongtai Biology has been committed to the application of advanced immunology, cell biology, genetics and other theories, combined with international advanced adoptive immunotherapy methods, to research and develop the immunotherapy and clinical application of major diseases such as tumors. The independent patent technology mastered-Amplification of Activated Lymphocytes (EAL,Expanded Activated Lymphocytes) has been successfully applied to clinical practice and has achieved very definite curative effects, it has been recognized by experts and patients, and has gradually become the fourth therapy for cancer treatment after surgery, radiotherapy and chemotherapy. Compared with similar technologies in China, this technology has higher safety, more obvious curative effect and less pain. High-quality cell products and services make Yongtai Bio a leader in the industry. In addition, the clinical application technology of antigen-specific lymphocyte and dendritic cell immunotherapy with international advanced level developed by Yongtai Biology has observed the results of cure and (or) long-term tumor recurrence in some patients.

EAL technology began to emerge in 2000, after nearly 20 years of development gradually mature. Clinical trials conducted in Japan show that EAL treatment for liver cancer patients after surgery can significantly delay the time of first recurrence and reduce the risk of recurrence by 41%. South Korea, the results of EAL alone and combination trials for patients with early and advanced liver cancer show that cellular immunotherapy can significantly prolong the median recurrence-free survival time and reduce the risk of death by 37%.

Before applying to CDE for clinical treatment, EAL of Yongtai Biology was managed as the third type of medical technology, and clinical treatment has been carried out on about 5000 patients in combination with regular treatment programs. The results show that it can significantly prolong the overall survival time of patients with malignant tumors such as non-small cell lung cancer, gastric cancer and colorectal cancer, and some patients have achieved long-term survival of more than 5 years using EAL cells alone. For example, in a trial of 65 children with AML admitted to the Department of Pediatrics of Peking University People's Hospital, it was found that EAL combined with chemotherapy was more effective than chemotherapy alone in the treatment of AML in children, and could significantly prolong the duration of MRD negative and event-free survival. In the combination therapy trial, adding cell therapy within 10 months of chemotherapy resulted in better MRD clearance in more patients.

In addition to EAL, Yongtai Bio also has deep pipeline reserves in the CAR-T field.

Yongtai Biology and the Cancer Center of PLA General Hospital jointly carried out a scientific research-type clinical trial of CAR-T-19 in the treatment of refractory and relapsing acute lymphoblastic leukemia and lymphoma, and achieved good therapeutic results. Between June 2017 and February 2018, 93% of trials with 14 children with B- ALL achieved remission.

Wing Tai Bio plans to submit IND applications for CAR-T-19 products in the middle of this year. In addition, other CAR-T products developed by Yongtai Bio include HBV, CD22, and BCMA, all of which have achieved valid preclinical data.

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