Event
On March 3, 2023, the company announced that Bouri Pharmaceutical, a wholly owned subsidiary of the company, had received the "Drug Registration Certificate" of Eribrin Mesylate injection issued by the State Drug Administration.
Comment
The chemical medicine synthesis session "Qomolangma" Eribrin injection was successfully approved, the first imitation was successful, and the superb synthetic ability was verified. The main results are as follows: (1) Eribrin mesylate injection was originally developed by Eisai for locally advanced or metastatic breast cancer that had received at least two chemotherapy regimens in the past; it is known as the chemosynthesis of Mount Everest because it contains 19 chiral centers and 93 steps. (2) the approval of Aribrin injection is the first approval in China according to the application for listing of four categories of chemicals, which is regarded as another successful first imitation chemical drug variety of the company through consistency evaluation, which once again verifies the company's superb synthetic strength. Prior to this, the company joined hands with Zhengda Tianqing to break through the import monopoly of Entecavir and successfully realize the first imitation of Entecavir. (3) the preparation pipeline is rich and the product structure is optimized. The company has carried out the transformation of "preparation integration" in recent years, and the approval of iribrin injection has further enriched the product pipeline of tumor preparations. According to Cortellis, global sales of Aribrine were about $353 million from 2021.10 to 2022.9.
Quarter-on-quarter revenue improvement, production base capital expansion, focusing on PDC innovation and research.
(1) according to the performance of KuaiBao, revenue in the fourth quarter of 2022 still maintained a recovery trend, with Q4 achieving revenue of 289 million yuan, an increase of 6.25% over the previous month. (2) the construction of the first phase of Borey (Shandong) API project and Borey Indonesia project has been basically completed, waiting for the release of production capacity at home and abroad.
The total investment of Taixing Phase II project will be increased from 310 million yuan to 500 million yuan. Taixing API and preparation production base (Phase II) is mainly for the production of intermediates and APIs such as Newmocontin, Ascomycin, Micafenac net Sodium, Anifenjing and Dabawanxing. (3) recently, the State Drug Administration has approved BGM0504 injection to carry out clinical trials on weight loss and indications for type 2 diabetes. At present, Novo-Nordisk A/S 's stramectin has been approved in similar products, and Eli Lilly and Co's GIP/GLP-1 double receptor agonist Tirzepatide has been approved by FDA in May 2022 for blood glucose control in adult patients with type 2 diabetes, but the indication for weight loss is still in the clinical stage. The available data have shown that the candidate product is more effective than the listed product.
Earnings forecast, valuation and rating
According to the performance KuaiBao, we lowered the 2022-23-24 year 4.18% Universe 9.04% Universe 10.04% to 10.62% 12.06% Universe 1.46 billion, an increase of 0.91% over the same period last year, an increase of 13.57% and 21.03%, and reduced the net profit of homing mother by 5.4% 9.3% to 2.57% 2.88 trillion. Maintain a "buy" rating.
Risk hint
The risk that the growth of product sales is not as expected, the production capacity is lower than expected, and the research and development of innovative drugs is not as expected.