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翰森制药(03692.HK):重磅仿制药哌柏西利上市 乳腺癌领域添新品

Hanson Pharmaceuticals (03692.HK): The blockbuster generic drug piperazil launches a new product in the field of breast cancer

國金證券 ·  Jul 5, 2022 00:00  · Researches

Event

On July 4, 2022, the company announced that the piperidi capsule developed by Jiangsu Hausen Pharmaceutical Co., Ltd., a subsidiary of the company, was approved to be listed by the State Drug Administration. The drug is suitable for locally advanced or metastatic breast cancer with positive hormone receptor (HR) and negative human epidermal growth factor receptor 2 (HER2). It should be used in combination with aromatase inhibitors as the initial endocrine therapy for postmenopausal women.

Comment

The second domestic piperacil capsule generic drug has been approved to be put on the market, adding new products in the field of breast cancer. (1) at present, three original CDK4/6 inhibitors have been approved to be put on the market in China, namely, Pfizer Inc's piperazeli (July 2018), Eli Lilly and Co's abexilide (December 2020) and Hengrui's dalsilyl ethanesulfonate (December 2021). (2) the world's first listed CDK4/6 inhibitor, palbociclib (trade name: Ibrance), was approved by Pfizer Inc in FDA in the United States in February 2015, and has been approved in China, Japan, the European Union and other countries. Since listing, global sales have increased year by year. According to Pfizer Inc's 2021 annual report, this product has become its third largest sales product, with global sales reaching 5.4 billion US dollars in 2021, including 3 billion US dollars in the United States and 2.4 billion US dollars in other regions. (3) in December 2020, Qilu Pharmaceutical's piperazeli capsule was approved to be put on the market and became the first imitation drug of this variety in China. (4) there are more than 20 new drugs with the same target in the field of breast cancer in China. Hansoh Pharmaceutical Group's piperazeli capsule has been approved as the second generic drug in China, which is ahead of other domestic pharmaceutical companies. Piperacil needs long-term medication, while Pfizer Inc's similar original drug is about 13600 yuan for a course of treatment (28 days) in China, and the cost is high. We expect that as the second generic drug in China, its annual cost will be much lower than that of the original drug, which may improve patient accessibility and gain greater market share.

The transformation of innovative drugs has been accelerated, and blockbuster products have been listed with high certainty. (1) the company implements the two-wheel drive strategy of "self-research + Becton Dickinson & Co". In 2021, the cost of independent R & D and Becton Dickinson & Co project is about 14.23 / 374 million yuan. With the increasing investment in independent R & D, Becton Dickinson & Co has also become a driver to accelerate the transformation of innovation. (2) the company has listed 5 class 1 innovative drugs, including more than 20 innovative drugs in the clinical stage. We expect sales of the company's blockbuster products ametinib and amitinofovir to peak at 5 billion and 2.5 billion yuan, respectively.

Profit forecast and investment suggestion

We maintain our profit forecast that the company's annual revenue in 2022-23-24 is estimated to be RMB 1241,145 billion, a year-on-year increase of 9.12%, 14.76%, 16.52%, and a net profit of 28.53, 3.225, 3.714 billion yuan, an increase of 5.18%, 13.01%, 15.18%. The current share price is trading at 33-29-26 times the PE for 2022-23-24. Maintain a "buy" rating.

Risk hint

The risk that R & D and new product sales are not as expected, and the risk that the company's revenue is under pressure, such as volume purchasing and so on.

The translation is provided by third-party software.


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