Bio-Thera Solutions Ltd(688177) (688177)
[matters]
Recently, Bio-Thera Solutions Ltd(688177) bevacizumab injection (pubeshi, 100mg / 4ml, 400mg / 16ml) has been approved by the State Drug Administration for the treatment of advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer (pubeshi) is the first candidate biological analogue of Avastin developed and carried out by a Chinese company in a global multicenter clinical trial. At present, it is in the stage of listing application in the United States and the European Union.
[comment]
Pubesi has a certain first mover advantage. At present, there are 5 kinds of bevacizumab injection approved for marketing in China, Bio-Thera Solutions Ltd(688177) which has a certain first mover advantage. Bevacizumab has added a large dosage form of 400mg / bottle, which is more in line with clinical needs. In addition, Fuhong Hanlin, Dongyao pharmaceutical, Betta Pharmaceuticals Co.Ltd(300558) , Zhengda Tianqing and other companies are also in the listing application stage, and pubeshi may face fierce market competition in the future.
There are commercial partners at home and abroad, and China cooperates with Baiji Shenzhou. Bio-Thera Solutions Ltd(688177) reached a cooperation agreement with Baiji Shenzhou in August 2020, Baiji Shenzhou will develop and commercialize Puxi in the Chinese market (including Hong Kong, Macao and Taiwan); Bio-Thera Solutions Ltd(688177) signed a license and commercialization agreement with Sandoz on September 8, Bio-Thera Solutions Ltd(688177) Will be responsible for the product development, production and supply of bevacizumab. Sandoz will be responsible for the commercialization of bevacizumab in the United States, Europe, Canada and most other international markets not covered by bevacizumab cooperation; Carry out licensing and commercialization cooperation with ciplagulffzllc, and authorize it to commercialize pubeshi's products in some emerging countries; Carry out licensing and commercialization cooperation with biomsa and authorize it to commercialize its exclusive products in the Brazilian market.
The company focuses on the R & D of innovative drugs and biological similar drugs, and has rich product R & D pipelines, mainly covering the fields of autoimmune diseases and tumors. Bevacizumab biological analogues have reached commercial cooperation with many institutions at home and abroad, covering many regions around the world. The company has gradually entered the harvest period. The company is based in China and distributes the global market. We maintained the operating revenue of the company in 2021, 2022 and 2023 as 508 / 1546 / 2622 million yuan respectively, the net profit attributable to the parent company as -761 / - 391 / 034 million yuan respectively, and the EPS as -1.84 / - 0.94/0.08 yuan respectively, maintaining the "overweight" rating.
[risk tips]
Uncertainty risk of drug research and development;
The progress of drug listing did not meet expectations;
The competition of competitive products intensifies the risk;
