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景峰医药(000908)点评报告:坚持走国际化高端特色仿创路线 渐入产品收获期

廣證恆生 ·  Dec 14, 2018 00:00  · Researches

  Incident: On December 9 and 11, the company announced that an abbreviated new drug application (ANDA) for amphetamine mixed salt oral tablets and prednisone tablets 2.5mg/5mg (applied by GeneYork Pharmaceuticals Group LLC, a joint venture between Shang Jin and Tianjin Jinyao Group Co., Ltd. in the US) has been approved by the US FDA. As of December 11, the company had obtained three US ANDA approvals in 2018. Comment: The company's high-end generic drugs have entered the harvest period one after another. Two hundred million generic drugs have been approved for listing in the US, and the company has adhered to the industrialization path of high-end generic innovative drugs in line with the international community. High-end generic drugs have gradually entered the harvest period: Recently, the holding subsidiary, the US, has advanced 2 generic amphetamine mixed salt oral tablets (5mg/7.5mg/10mg/12.5mg/15mg/20mg/30mg) and prednisone tablets (2.5mg/5mg/10mg, 20mg and 50mg) were approved for listing by the FDA. In 2017, sales in the US all exceeded $100 million, amphetamine-mixed salt tablets were about $4.1 billion, and prednisone tablets were about $139 million. ANDA's approval means that the company can produce and sell these two products in the US, which has a positive impact on the company's international development of the pharmaceutical market and improvement of the company's performance. The amphetamine mixed salt oral tablet project company only took 10 months from application to approval. It was approved super quickly, so it can also be called “Goal Date”. Amphetamine mixed salt oral tablets are controlled neurodrugs, marking the company's breakthrough in high-barrier controlled drugs. The company's holding subsidiary, American Shang Jin, is a favorable driving force for the company's deployment in the US market. Shang Jin is familiar with the US ANDA registration process and cGMP site inspection process and management, and has many years of research and development experience in the US. Currently, a total of 8 products of Shangjin have been declared for ANDA, and it is expected that more than 10 products will complete ANDA declarations by the beginning of 2019. Also, it is expected that applications for products with more advanced oral formulations and higher barriers will be completed next year. Potential varieties of flurbiprofen ester injections are included in medical insurance and are expected to become the company's new profit growth point. Flurbiprofen ester injections are mainly used for post-operative and cancer analgesia. Total domestic sales in 2017 were 2.3 billion yuan, and sales in the first half of 2018 were about 900 million yuan, an increase of 25% over the previous year. Flurbiprofen ester injections have been covered by national health insurance category B. The company's declared production of flurbiprofen ester injections for analgesic indications has been accepted and is expected to be approved for marketing in 2019. At present, the new adaptation has entered the second phase of clinical trials, and is expected to become a new profit growth point for the company in the future. Market-oriented, technology-centered, and adhering to international high-end characteristics, the company makes drugs with high quality international standards. Currently, Shanghai Jingfeng's biological production line and high-end liposome production line have been completed; Guizhou Jingfeng's small-volume injection production line, solid oral administration and freeze-drying production line are being transformed; among them, Shanghai Jingfeng's liposome production line and Guizhou Jingfeng's small-volume injection production line, solid oral administration and freeze-drying production line are actively preparing a cGMP certification system. It is expected that the product will pass the FDA declaration in 2019 and pass cGMP certification in 2020. Profit forecast and valuation. Based on the company's current business situation, we estimate that the company's EPS for 18-20 was 0.20/0.22/0.25 yuan, respectively, and the corresponding valuations were 22/19/17 times, respectively, maintaining the “highly recommended” rating. Risk warning: Formulation growth falls short of expectations; risk of impairment of goodwill; industry policy risk.

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