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君实生物(688180):加速后期管线研发 强化核心产品持续发力

Junshi Biotech (688180): Accelerate later pipeline development and strengthen the continuous development of core products

天風證券 ·  Nov 20, 2023 07:36

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Recently, the company released its report for the third quarter of 2023. Operating income for the first three quarters was 986 million yuan, down 19.04% year on year; net profit was -1,407 million yuan, down 11.78% year on year; net profit after deducting non-return mother was -1,359 million yuan, down 17.46% year on year. In the third quarter alone, the company achieved operating income of 317 million yuan, a year-on-year increase of 16.31%; net profit of net income of -409 million yuan, a year-on-year decrease of 39.998%; net profit after deducting non-return net profit of -388 million yuan, a decrease of 44.62% year-on-year loss.

Drug sales revenue continues to grow, and the company's hematopoietic capacity is further strengthened. The company's main revenue comes from drug sales. As of the first three quarters of 2023, treprilizumab had achieved sales revenue of about 668 million yuan, an increase of about 29.7% over the previous year. Remidevir deuterium hydrobromide tablets achieved sales revenue of 124 million yuan, particularly in the second quarter of 2023. Driven by the trend of the epidemic, sales increased significantly. Since the price adjustment on April 1, 2023, the product has continued to be temporarily included in the scope of medical insurance payments, further boosting sales development. Adalimumab achieved sales revenue of 99.4 million yuan.

The readout of treprilimab data was completed efficiently, and overseas approval progressed smoothly. In the first half of this year, treprilizumab made significant progress in phase III studies: Neotorch (January), TORCHLIGHT (February), RENOTORCH (April), EXTENTORCH (May), and NCT05342194 (June). At the same time, marketing applications for the drug have also been accepted by the Chinese NMPA for new indications, including non-small cell lung cancer perioperative period (April), triple-negative breast cancer (May), renal cell cancer 1L (July), and small cell lung cancer 1L (July). In September, the company announced that the phase III clinical study on first-line treatment of melanoma with treprilizumab had achieved critical success. MPFs had benefited significantly, becoming the first case in China where a registered clinical study on first-line treatment of advanced melanoma with PD- (L) 1 inhibitors achieved positive results. In overseas markets, the company has initiated more than 40 clinical studies initiated by the company worldwide (including China, the US, Southeast Asia and Europe), covering more than 15 different indications. In addition, the US FDA has completed on-site inspections of the company's domestic production sites and approved the listing, while treprilizumab's marketing applications in the UK and EU are also under review.

The company's late-stage R&D projects are advancing at an accelerated pace, and growth momentum is gaining momentum. The marketing application for angoricizumab has been accepted by the NMPA. It covers indications including primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia, as well as homozygous familial hypercholesterolemia for adults or adolescents aged 12 and over. Furthermore, the drug tifcemalimab being developed by FIC has been approved to conduct an international multi-center phase III clinical study. This is the first confirmatory study of BTLA target drugs. JS005 for the treatment of moderate to severe plaque-like psoriasis has entered phase III, and communication for registered clinical trials for ankylosing spondylitis has begun. In addition, the clinical trial application for JS207 (anti-PD-1 and VEGF bispecific antibodies) has been approved by the National Drug Administration, and the administration of the first case of the subject has been completed.

Profit Forecasts and Investment Ratings

Considering the company's financial data for the third quarter and subsequent volume expectations, we adjusted the company's expected operating income from 2023 to 2025 from 2,040 billion, 2,924 billion, and 3.740 billion yuan to 1,502 billion, 2,591 billion yuan, and 3.796 billion yuan, and the expected net profit from -1,034 million, -634 million, and -496 million yuan to -1,926 million, -1,188 billion, and -464 million yuan. Maintain a “buy” rating.

Risk warning: business risk, risk of failure in research drug development, risk of policy changes, risk of increased market competition

The translation is provided by third-party software.


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