Green Leaf Pharmaceuticals announced that its product Rykindo (risperidone sustained release microsphere injection, LY03004) has been approved by FDA for the treatment of adult patients with schizophrenia and maintenance therapy for adult patients with bipolar disorder type I as a single drug or as an adjuvant therapy for lithium or valproate.
Rykindo is the first new drug in the field of central nervous system therapy independently developed by a Chinese pharmaceutical company and approved for sale in the United States, which indicates that the overseas listing channel of Green Leaf products has been opened.
Rykindo is independently developed by Greenleaf Pharmaceutical based on the patented microsphere technology platform. It is the first new drug in the field of central nervous system therapy independently developed by a Chinese pharmaceutical company and approved for market in the United States. It is also the first complex preparation product developed by Chinese mainland Pharmaceutical Company to be approved for market by FDA under terms 505 (b) (2). The approval of Rykindo by FDA means that Green Leaf Pharmaceuticals has met the sea standards from the innovation and clinical value of the drug itself, to patent protection, to CMC management, and to clinical data management, opening up expectations for the subsequent listing of seafood.
The pipeline products Torudi venlafaxine and paliperidone sustained release suspension injection in the field of central nervous system of Green Leaf Pharmaceutical are all expected to go out to sea and have a broad space. Torudi Lafaxine, the follow-up variety of the central nervous system of Greenleaf Pharmaceuticals, is a new molecular form and a new triple reuptake inhibitor in mechanism. FDA formally accepted its listing application in March 2020. The analysis of data from key clinical trials conducted in the United States has also been completed in November 2022, showing superior results in administration patterns compared to the control drug INVEGASUSTENNA. Torudi Lafaxine is an antidepressant for indication, and the target product, Vortioxetine, has global sales of about US $1.64 billion in 2021. The indication of paliperidone suspension injection is schizophrenia, and the global sales of the standard product INVEGA is about 4 billion US dollars in 2021. There is a broad space for the follow-up varieties of Green Leaf Pharmaceutical.
Green Leaf Pharmaceutical domestic stock varieties clear and inflection point upward, incremental varieties continue to realize in 2023 will usher in a number of catalysis. Green Leaf Pharmaceutical stock variety Lipoxu has been cleared after a round of adjustment, and is expected to return to growth, other stock varieties Siruikang remain stable, Xuezhikang stable growth. In addition to Ruixintuo and Ruoxinlin, which have been approved for market, the varieties expected to be put on the market in 2023 are Gosserrelin microspheres, small cell lung cancer innovative drug Lurbinectedin, and oxycodone naloxone sustained-release tablets. Stock variety inflection point upward, incremental varieties continue to cash, Green Leaf Pharmaceutical has entered a new stage of development.
Maintain the "highly recommended" investment rating. We estimate that the net profit of Green Leaf Pharmaceutical from 2022 to 2024 is 810 million yuan, 970 million yuan and 1.46 billion yuan respectively, corresponding to 15x, 13x and 9x PE. We are optimistic about the domestic growth and overseas expansion of Green Leaf Pharmaceutical, and maintain the "highly recommended" investment rating.
Risk tips: research and development is not as expected, commercialization is not as expected, competition is intensified, overseas registration review progress is not as expected, payment policy changes and other risks.