\u3000\u3000 Beijing Konruns Pharmaceutical Co.Ltd(603590) (603590)
Event:
On the evening of February 23, the company issued the announcement on kc1036 entering phase Ib / II clinical research. The company's class I innovative drug kc1036 has excellent antitumor activity in phase I clinical research, and has decided to carry out phase Ib / II clinical research.
Kc1036 is the world's first class 1 new drug. Kc1036 is a research and development product in the field of cancer strongly dominated by the company. It belongs to a new structure of targeted antitumor drugs and meets the company's "global new" research and development standards. Its treatment scope includes non-small cell lung cancer, gallbladder cancer, cholangiocarcinoma, gastric cancer and leukemia. It is the world's first new small molecule antitumor drug with multi-target receptor tyrosine kinase Axl / VEGFR2 / FLT3. If it is successfully promoted, it is expected to enrich the company's product pipeline in malignant tumor treatment and other fields in the future.
The overall performance of clinical phase I data was excellent. In the phase I clinical trial, kc1036 achieved excellent performance in anti-tumor effect, clinical specificity, safety and tolerance. In the clinical phase I trial of 23 clinical subjects, 15 subjects completed at least one tumor evaluation. There were 10 cases of stable disease in the trial group, of which 2 cases had the best curative effect; The objective remission rate was 13.3%, and the disease control rate was 80%; Two patients with partial remission are still in continuous remission, and the continuous remission time has reached 3 months. The more common adverse reactions observed at this stage are mainly abnormal clinical laboratory test indicators and nausea, most of which are mild to moderate adverse reactions. The results show that kc1036 has excellent antitumor activity, good safety and tolerance. According to the results of kinase inhibition experiments, KC1036 has selected 5 indications for bile duct cancer, gallbladder cancer, esophageal cancer, gastric cancer and pancreatic cancer, which have not yet met the needs of clinical treatment. The results showed that the effective rate of kc1036 (TGI ≥ 60%) was 100%, and the effective rates of 5-FU and gemcitabine were 0% and 60%; In the gallbladder cancer model, the effective rate of kc1036 was 80% and that of gemcitabine was 60%.
The research and development has been carried out smoothly and entered clinical phase Ⅰ B / Ⅱ. Based on the smooth progress of the clinical trial of kc1036, the company announced on the evening of February 23 that it would cooperate with the Cancer Hospital of the Chinese Academy of Medical Sciences to jointly carry out the phase II clinical study of kc1036ib. The trial will be conducted simultaneously with QD and bid administration schemes. Under different administration schemes, the preliminary efficacy of kc1036 in patients with advanced recurrent or metastatic digestive system tumors will be observed.
R & D investment continues to increase, and non-public offering provides long-term R & D guarantee. In terms of R & D capacity, the company's R & D expenses in the first three quarters were 66.4391 million yuan, a year-on-year increase of 7.91%, accounting for 11.14% of the company's revenue, higher than the industry average. As the key product of the company's current R & D pipeline, kc1036 has accumulated R & D investment of 152 million yuan. In the long run, through continuous R & D investment, the company is expected to usher in the diversified realization of innovative achievements. In addition, in 2021, the company issued a plan for non-public offering of a shares, raising a total of no more than 300 million yuan. All the raised funds will be used for the R & D project of innovative drug kc1036, providing strong support for the follow-up R & D of kc1036 and other projects.
Investment suggestion: we expect the diluted EPS of the company from 2021 to 2023 to be 1.38 yuan, 1.63 yuan and 1.91 yuan respectively, and the corresponding dynamic P / E ratios are 21.54 times, 18.23 times and 15.56 times respectively. Beijing Konruns Pharmaceutical Co.Ltd(603590) as a leading enterprise in the subdivided field of China's hemagglutinase preparation industry, benefiting from the recovery and growth of surgical personnel in medical institutions, through continuous R & D innovation and product introduction and rich product pipelines, the company's R & D projects are smoothly promoted. In the future, the company is expected to usher in the diversified cashing of innovation achievements and maintain the buy rating.
Risk warning: policy risk, R & D risk and M & A are lower than expected.
