The first unprofitable enterprise of science and technology innovation board is approved to register! All products are in the R & D stage

category:Finance
 The first unprofitable enterprise of science and technology innovation board is approved to register! All products are in the R & D stage


At present, the company is still unable to make profits and has accumulated unrepaired losses, mainly due to the fact that all products of the company are in the stage of R & D, have not yet carried out commercial production and sales, and have not yet realized sales revenue.

Domestic targeted new drug donafinil tablets

At present, the main products of Zejing pharmaceutical which have entered the clinical trial stage are donafinil toluene sulfonate tablets (zepusen), recombinant human thrombin for external use (zepusen), jaketinib hydrochloride tablets (zepusen), orcatinib, recombinant human thyrotropin for injection (rhTSH), jaketinib hydrochloride cream, etc. Donafinil toluenesulfonate tablet is the core of the above-mentioned products, which is close to the listing and commercialization of new drugs. It may become a product with great impact on the companys performance.

Zejing pharmaceutical said that donafinil is the first domestic targeted new drug to carry out phase III clinical trials of first-line treatment of advanced liver cancer in China. It is expected to complete phase III clinical trials of this product in the first-line treatment of advanced liver cancer by the end of 2019 or early 2020, and submit NDA in the first quarter of 2020. At present, the targeted drugs for the treatment of first-line HCC are solafeni from Bayer company in Germany and renvatinib from Weicai company in Japan. The patent protection period of solafeni compound is from January 2020, the patent protection period of crystalline form is from September 2025; the patent protection period of renvatinib compound is from October 2021, and the patent protection period of crystalline form is from December 2024.

The company is expected to complete the phase III clinical trial of donafinil in the treatment of advanced colorectal cancer in 2020 and submit the listing application, and it is expected to complete the phase III clinical trial of donafinil in the treatment of local advanced / metastatic radioiodine refractory differentiated thyroid cancer and external recombinant human thrombin in the treatment of surgical bleeding and hemostasis in 2021 and submit the listing application.

Once approved for marketing, donafinil will compete directly with solafeni and lovatinib, the first-line therapeutic drugs for HCC, as well as with the generic drugs of solafeni and lovatinib after the expiration of their respective patents.

It is reported that sorafenib was approved to be listed in July 2008, and its sales volume in China in 2018 was 710 million yuan, accounting for 87.7% of the market share of first-line liver cancer targeted treatment drugs; and renvaltinib was approved to be listed in China in September 2018, and its sales revenue in China in 2018 was 100 million yuan, accounting for 12.3% of the market share of first-line liver cancer targeted treatment drugs.

Over 40% of annual R & D investment

Up to now, the company has 11 product pipelines of 29 research projects of drugs under research; at the same time, the company reserves a number of research projects in the early pre clinical research stage. Zejing pharmaceutical said that in the future, it still needs to continue large-scale R & D investment to complete product pipeline R & D businesses such as clinical trials, pharmaceutical research, preclinical research and new drug preparation before marketing.

During the reporting period, from January 2016 to June 2019, the R & D expenses invested by Zejing pharmaceutical were 61.0774 million yuan, 159 million yuan, 143 million yuan and 75.7106 million yuan respectively, of which the R & D expenses after the research project entered the phase III clinical trial accounted for 63.29%, 47.22%, 41.01% and 18.07% respectively.

According to the disclosed information, the financing amount of this listing is 2.384 billion yuan, which will be fully used for the projects related to the main business and the working capital required for the development of the main business.

The company has built two core technology platforms, i.e. precise small molecule drug R & D and industrialization platform and complex recombinant protein new drug R & D and industrialization platform. Relying on these two technology platforms, the company has developed a wealth of product pipelines for new small molecule drugs and recombinant protein drugs, covering a variety of cancer and blood tumors such as liver cancer, non-small cell lung cancer, colorectal cancer, thyroid cancer, nasopharyngeal cancer, bone marrow proliferative diseases, as well as bleeding, hepatobiliary diseases and other treatment fields. The goal is to become one of the leading enterprises in the research and development of new drugs in the above fields in China. In addition, while focusing on the development of its own R & D pipeline, the company and well-known domestic pharmaceutical companies are actively promoting the research on the combination treatment of small molecule targeted new drugs and anti-PD-1 / PD-L1 antibodies for tumors. According to the disclosure, during the reporting period, Wuxi apptec and tag pharmaceutical ranked among the top five suppliers of the company for three consecutive years. Source: responsible editor of Beijing Youth Daily: Guo Chenqi, nbj9931

The company has built two core technology platforms, i.e. precise small molecule drug R & D and industrialization platform and complex recombinant protein new drug R & D and industrialization platform. Relying on these two technology platforms, the company has developed a wealth of product pipelines for new small molecule drugs and recombinant protein drugs, covering a variety of cancer and blood tumors such as liver cancer, non-small cell lung cancer, colorectal cancer, thyroid cancer, nasopharyngeal cancer, bone marrow proliferative diseases, as well as bleeding, hepatobiliary diseases and other treatment fields. The goal is to become one of the leading enterprises in the research and development of new drugs in the above fields in China.

In addition, while focusing on the development of its own R & D pipeline, the company and well-known domestic pharmaceutical companies are actively promoting the research on the combination treatment of small molecule targeted new drugs and anti-PD-1 / PD-L1 antibodies for tumors. According to the disclosure, during the reporting period, Wuxi apptec and tag pharmaceutical ranked among the top five suppliers of the company for three consecutive years.