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复星医药(600196):取得汉斯状美国权益 试水PD-1出海

Fosun Pharmaceutical (600196): Obtaining Hans-like US interests and testing the waters for PD-1 to go overseas

國金證券 ·  Nov 18, 2022 00:00  · Researches

Event

On November 18, 2022, Fuhong Hanlin, a subsidiary of the company, signed a license agreement with the company to grant the company an exclusive license to commercialize Hans in the United States.

Comment

With the addition of global operating products, the commercialization of Hans-like products in the United States has accelerated. (1) PD-1 McAb (trade name: Hans shape), developed by Fuhong Hanlin, a subsidiary of the company, was put on the market in China in March 2022. It has been approved for MSI-H solid tumor and combined chemotherapy for sqNSCLC. (2) under this license agreement, the company acquires the commercial interest of Hans-shaped in the United States and will pay Fuhong Hanlin: ① 1 billion RMB down payment; ② US $50 million regulatory milestone payment (if Hans-shaped BLA is approved by FDA); ③ subsequent sales milestone payment of not more than 650 million US dollars (if annual net sales reach 3x5 pound 1015pm 2 billion, respectively

Us $0.45, 0.75, and 1.5, 000, 200, 000, 000 (3) at present, the company has initially completed the construction of the global operation system, accelerated the going out of the sea of superior products, and has established professional commercial teams in Africa, the United States and other overseas countries. As of the first half of 2022, the company has partnered with 5 large distributors and 16 GPO in the United States. We believe that the commercialization of Hans shape in the United States is the exclusive responsibility of the company, with the help of the company's initial overseas sales system, we can achieve higher recognition, and the company has further enriched the product pipeline with the potential to go to sea. (4) the first indication for listing in the United States is extensive small cell lung cancer (ES-SCLC+). Before it is approved by the United States BLA, all development work will continue to be completed by Fuhong Hanlin. According to the results of Fuhong Hanlin's previous discussions with FDA, 100 subjects will be recruited in the United States for bridging trials, which are expected to be submitted to BLA by the end of 2023.

Serurizumab combined with chemotherapy showed excellent clinical benefits in the treatment of SCLC. Compared with the placebo + chemotherapy group, the median OS:15.4 months was vs10.9 months; the median PFS months was 5.7months vs4.3 months.

Self-research, cooperation, license introduction and deep incubation multi-drive, new product volume to revenue structure optimization, gross profit margin continues to rise quarter by quarter. The proportion of revenue from new products increased in the first three quarters of 2022, with gross profit margins rising from 43.55% in the first quarter and 45.76% in the second quarter to 46.51% in the third quarter. The optimization of revenue structure continues.

Earnings forecast, valuation and rating

We maintain our revenue forecast and estimate that the company's annual revenue in 2022-23-24 will be 448.56 billion yuan, 51.674 billion yuan, and the net profit attributable to the parent company is 39.84 billion yuan, 53.73 billion yuan. The company's current share price is multiple of 26-19-15 corresponding to the annual PE of 2022-23-24. Maintain a "buy" rating.

Risk hint

New drug research and development and marketing process is not up to expectations, collection and other policies affect profitability and other risks.

The translation is provided by third-party software.


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