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石药集团(01093.HK):神经痛与癫痫领域两药获批 CNS再添新品

Shiyao Group (01093.HK): Two drugs in the fields of neuralgia and epilepsy were approved by CNS and new products added

國金證券 ·  Jul 12, 2022 00:00  · Researches

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On July 11, 2022, the company announced that the company's subsidiary Shiyao Group Euroyai Pharmaceutical's gabapentin capsules and lacoxamide injections were approved for listing in China. Gabapentin is suitable for the treatment of post-herpetic neuralgia in adults, adjuvant treatment for partial seizure with or without secondary generalized seizures in adults and children aged 12 and over, adjuvant treatment for partial seizure in children aged 3-12; lacosamide is suitable for the combined treatment of partial seizures in people aged 4 and above with epilepsy.

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The variety of neurological diseases has been expanded again, and gabapentin capsules are effective in both analgesia and anticonvulsants.

This medicine can be used to treat postherpetic neuralgia (PHN). (1) There are more than 1.3 million PHN patients in China. Since the virus persists in the dorsal root ganglia of the cranial or spinal nerves, pain persists in as many as 30% of patients after herpes disappears. (2) Currently, a number of first-line drugs for treatment recommended in PHN drug treatment guidelines have been marketed overseas, including calcium ion channel modulators, pregabalin, and gabapentin. (3) The original Gabapentin research drug was developed by Pfizer (Pfizer), and various dosage forms such as capsules, tablets, and oral solutions are marketed domestically and internationally; global sales in 2021 were US$1.68 billion. In China, Hengrui, Enhua, Beijing Fourth Ring Road, Shandong Bainuo, and Zhejiang Yongtai have been approved for listing.

The drug can also be used for adjuvant treatment of partial seizures without secondary new generalized seizures in adults and children over 12 years of age, and adjuvant treatment of partial seizures in children aged 3-12 years.

The injectable form of lacosamide, a drug used for epilepsy, was approved for the second time in China.

Epilepsy is one of the most common chronic neurological diseases in the world. There are about 50 million people with epilepsy in the world and about 10 million in China. Lacosamide injections are an alternative administration option for patients when oral administration is not feasible.

The original drug lacosamide was developed by Ushibi in Belgium. It was first approved for listing in the European Union in September 2008, with the trade name Vimpat; global sales in 2021 were 1,549 million euros, the 5-year CAGR was 9.68%, and sales continued to grow. In China, Vimpat was approved for tablets, injections, and oral solutions respectively in 2018/19/20. A number of domestic companies have set up the lacosamide market. In November 2020, Qingfeng Pharmaceutical was approved for the first injection form.

Profit forecasting and investment advice

We maintain our profit forecast and expect the company to achieve revenue of 321/370/43.2 billion yuan in 2022/23/24; the net profit of the mother is 61/69/8 billion yuan. The company's current stock price corresponds to 2022/23/24 PE 13/11 times, respectively, maintaining the “buy” rating.

Risk warning

The risk of new drug development and new product sales falling short of expectations; the risk of profit pressure due to harvesting, etc.

The translation is provided by third-party software.


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