于本公告日期，公司已完成II期临床试验所需的272名目标患者入组工作。根据II期临床试验的目前进度，公司管理层深信最快将于2021年第四季完成中期数据分析，并向国家药监局提交产品举行新药预备会议的申请。Yongtai Bio-B(06978) according to the results for the six months ended June 30, 2021, the group achieved other income of 6.435 million yuan (the same unit below), an increase of 560% over the same period last year, and R & D expenditure of 107 million yuan, an increase of 13.02% over the same period last year. The owner of the company incurred a loss of 147 million yuan and a basic loss of 0.29 yuan per share.
According to the announcement, EAL ®is a multi-target cellular immunotherapy product with a track record of more than a decade in the clinical application of cancer treatment. EAL ®is a preparation originally taken from the patient's autologous peripheral blood by activating and amplifying T cells using proprietary methods. The main active ingredient of the product is CD8+ killer T cells (surface labeled with CD3 molecule).
EAL ®is conducting a phase II clinical trial to prevent postoperative recurrence of liver cancer. Based on the communication between the company and the drug review center, the company may use the interim results of ongoing clinical trials or the final results after the conclusion of clinical trials to apply for marketing permission for EAL ®to prevent postoperative recurrence of liver cancer, provided that the results are statistically significant. After obtaining the results of clinical trials that can support the effectiveness of EAL ®, the company can further communicate with the Drug Review Center to facilitate the review.
As of the date of this announcement, the company has completed the enrollment of 272 target patients required for phase II clinical trials. Based on the current progress of the phase II clinical trial, the company's management is confident that the interim data analysis will be completed by the fourth quarter of 2021 at the earliest and submit an application for a new drug preparatory meeting to the SFDA.
The company plans to further increase investment and expand the number of areas participating in ongoing EAL ®II clinical trials to accelerate patient enrollment and access to the required data, while advancing future commercial layouts.
When the cellular immunotherapy products are removed from the laboratory, the cell activity will be reduced. As of the date of this announcement, the company has confirmed the establishment of production centers in Beijing and Shaoxing. For the six-hour transportation radius of EAL ®, the company is planning to set up an R & D and production center covering major population centers across the country. After establishing operations in Beijing, Shaoxing and Shenzhen, the company plans to establish production centers in Chengdu, Wuhan, Xi'an and Shenyang and other major cities.
