Betta Pharmaceuticals Co.Ltd(300558) (300558)
event
Betta Pharmaceuticals Co.Ltd(300558) recently issued several Announcements: the supplementary application for new indications of bevacizumab was accepted by nmpa; Bpi-361175 was approved by FDA for clinical trials; The indications of postoperative adjuvant therapy of ektinib hydrochloride and ensatinib hydrochloride were included in the national medical insurance catalogue.
Key investment points
Six new indications declared by bevacizumab were accepted by nmpa
In November 2021, the company's bevacizumab (trade name: Betaine ®） Approved for marketing, the indications are the treatment of patients with advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer. This product is Aventin ® A biological analogue of, Aventin ® Monoclonal antibodies targeting VEGF, developed by Roche, were listed in China in 2010. The product has a wide range of indications, with annual global sales of more than 7 billion US dollars.
In December 2021, the company applied for beiantin ® The supplementary application for 6 new indications has been accepted by nmpa, and the scope of medication is expected to be further expanded. Betaine ® It is the first macromolecular monoclonal antibody of the company and the third product listed after ektinib and ensatinib. Betaine ® The successful listing of has enriched the company's product structure, filled the gap of macromolecular biological drugs, and laid a good foundation for sequential and combined treatment of tumors.
Ektinib postoperative adjuvant and ensatinib were included in the medical insurance catalogue
In December 2021, the dynamic negotiation results of national medical insurance were announced, and the adjustment of national medical insurance drug catalogue was successfully completed, which will be implemented from January 1, 2022. In this negotiation, the company successfully negotiated the indications of postoperative adjuvant therapy of ektinib and ensatinib, which is expected to have a positive impact on the company's performance.
Postoperative adjuvant therapy is the third indication approved by ektinib and the world's first generation of EGFR-TKI for postoperative adjuvant targeted therapy of non-small cell lung cancer. The entry of postoperative adjuvant treatment indications into medical insurance is expected to drive the continuous growth of ektinib sales and provide new treatment options for more postoperative people.
Ensatinib is the second generation alk-tki and the first domestic ALK drug. After entering the medical insurance, the drug price of guotan has decreased, and it is competitive with similar competitive products in price, which is expected to further accelerate the large-scale production of products.
Fourth generation EGFR clinical trial application approved by FDA
On December 5, 2021, the company's clinical trial application for bpi-361175 was approved by FDA. Bpi-361175 is a small molecule drug independently developed by the company for the treatment of non-small cell lung cancer carrying egfrc797s mutation and other EGFR related mutations. The product was approved by Chinese clinical in February 2021. In August 2021, the first subject of phase I clinical study in China was successfully enrolled and completed the first administration. The clinical study is progressing smoothly. This product is the fourth generation EGFR drug after the first generation EGFR ektinib and the third generation EGFR bevotinib. At present, the drugs carrying egfrc797s mutation outside China are in the preclinical or early clinical stage, and there is no drug on the market. The company's drug layout in the field of lung cancer is perfect, laying the foundation for the sequential treatment of NSCLC patients.
Profit forecast
It is estimated that the net profit attributable to the parent company from 2021 to 2023 will be RMB 487 million, RMB 648 million and RMB 816 million respectively, and the corresponding EPS will be RMB 1.17, RMB 1.57 and RMB 1.97 respectively. The corresponding PE of the current stock price will be 68.5/51.4/40.8 respectively, maintaining the "recommended" rating.
Risk statement
Industry policy risk; The risk that the sales of core products do not meet the expectations; The progress of new drug research and development and marketing is less than the expected risk.
