\u3000\u3000 Beijing Konruns Pharmaceutical Co.Ltd(603590) (603590)
Key investment points
Matters: 1. The innovative drug]kc1036 independently developed by the company entered the phase Ib / II clinical study. 2. The company carried out the clinical trial of Agkistrodon acutus haemagglutinin for injection in dogs.
Kc1036 is about to enter phase Ib / II clinical study. The indications of this study were late recurrent or metastatic digestive system tumors. A multicenter, open trial design was adopted. The team leader was the Cancer Hospital of the Chinese Academy of Medical Sciences. There are more than one million new digestive system tumors such as gastric cancer, esophageal cancer and colorectal cancer in China every year. The mortality of digestive system tumors is generally high, and there is an urgent need for drugs with better curative effect. The Cancer Hospital of the Chinese Academy of Medical Sciences ranks first among the cancer hospitals in China and has a high academic influence in the industry. Kc1036 can be recognized by the hospital and take the lead in clinical trials. The follow-up results are worth looking forward to.
Preclinical study data of kc1036 showed antitumor activity and good tolerance. Kc1036 is the first type of innovative chemical drug developed by the company and not listed at home and abroad. It is a new multi-target receptor tyrosine kinase inhibitor mainly Acting on Axl / VEGFR2 / FLT3. The results of preclinical pharmacodynamics study showed that in the models of esophageal cancer and cholangiocarcinoma, the effective rates of kc1036 (TGI ≥ 60%) were 100%, and the effective rates of control drugs 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 results showed that kc1036 showed obvious antitumor effect at low dose level, and was safe and well tolerated.
Phase I clinical data show that it is safe and effective for a variety of tumors. The phase I clinical study of kc1036 included 23 subjects, including lung adenocarcinoma, rectal cancer, cholangiocarcinoma, thymic cancer, lung squamous cell carcinoma, esophageal cancer, soft tissue sarcoma and other tumors. The median number of previous systematic treatment lines was 2. 15 subjects completed at least one tumor assessment, with an orr of 13.3% and a DCR of 80%. Two PR subjects are still in continuous remission, and the continuous remission time has reached 3 months. In terms of safety, as of August 2021, the more common adverse reactions observed were abnormal clinical laboratory test indicators and nausea, and the adverse reactions were grade 1 ~ 2. The results showed that kc1036 single drug had good safety and tolerance, and showed prominent antitumor activity in patients with advanced solid tumors.
The company is committed to building a “global new” innovative new drug, and the R & D pipeline is advancing smoothly. At present, the company’s two anti-tumor innovative drugs kc1036 and cx1003 are in the clinical stage, and kc1036 has completed the first clinical stage. Cx1003 is currently in phase I clinical stage and is normally promoted according to the clinical plan. Cx1026 project is in preclinical stage.
Suling carries out clinical research on canine hemostasis, which is expected to expand the pet market. According to the data of prospective industry research institute, the number of pet cats and dogs in China reached 99.15 million in 2019, and the annual surgical operation volume is expected to be one million. The corresponding surgical hemostatic drug market still has large space, which is expected to further promote the growth power of suling. In addition, pet medicine belongs to the independent consumer market, which is not affected by the cost control of medical insurance, and the product price is more flexible.
Maintain the “buy” rating. It is estimated that the EPS from 2021 to 2023 will be 1.16 yuan, 1.35 yuan and 1.52 yuan respectively, and the corresponding PE will be 26x / 22x / 20x respectively. With the consolidation of the company’s existing business and the promotion of innovative business, entering the orthopedic market is conducive to long-term development. Suling is expected to open up growth space and maintain the “buy” rating by entering pet medicine.
Risk tips: market competition risk, downward risk of drug price and risk of new drug research and development.
