Changchun High And New Technology Industries (Group) Inc(000661) product registration has made a breakthrough and the market space continues to expand

\u3000\u30 Shenzhen Zhenye(Group)Co.Ltd(000006) 61 Changchun High And New Technology Industries (Group) Inc(000661) )

Event: on April 6, 2022, the company issued an announcement: 1) the State Food and Drug Administration issued the approval documents of polyethylene glycol recombinant human growth hormone injection and recombinant human growth hormone injection; 2) The application for marketing license of the company’s subsidiary ” Changchun Bcht Biotechnology Co(688276) ” live attenuated herpes zoster vaccine was accepted by the food and drug administration.

The long-acting growth hormone increases the injection pen, and the short-acting growth hormone increases the indications. On April 6, 2022, the State Drug Administration announced that the approval certificates of polyethylene glycol recombinant human growth hormone injection and recombinant human growth hormone injection of Changchun High And New Technology Industries (Group) Inc(000661) subsidiary kinsay pharmaceutical have been issued. The polyethylene glycol recombinant human growth hormone injection (54iu / 9.0mg / 1.0ml / bottle) in this supplementary application is the preparation, and the card bottle packaging form is added. The recombinant human growth hormone injection (30iu / 10mg / 3ml / bottle) is the new indication for the short stature of children caused by small for gestational age (SGA) (no catch-up growth at the age of 2). The drug approval and registration certificate of relevant products is expected to be obtained in the near future. The injection pen will increase the convenience of using long-acting growth hormone, and the approval of new indications will further expand the product market.

Changchun High And New Technology Industries (Group) Inc(000661) subsidiary Changchun Bcht Biotechnology Co(688276) herpes zoster vaccine marketing license application has been accepted. The live attenuated herpes zoster vaccine is a class 3.2 biological product for prevention and has received the acceptance notice issued by the State Food and drug administration. Herpes zoster (Hz) is an acute infectious skin disease caused by reactivation of varicella zoster virus (VZV), which is latent in the body. In the acute attack stage, it is characterized by rash and pain, blisters, red spots and induration on the surface of one side of the skin; The chronic stage is persistent post rash neuralgia. At present, there are two herpes zoster vaccines on the market worldwide, Zostavax of MSD and shinrix of GlaxoSmithKline. In China, only shingrix produced by GlaxoSmithKline has been put on the market, and the vaccine was officially put on the market in China on June 28, 2020. If Changchun Bcht Biotechnology Co(688276) ‘s herpes zoster vaccine progresses smoothly, it will help enrich the company’s existing vaccine varieties, optimize the product structure, contribute to the overall development of industrial layout and main business, and enhance the company’s overall long-term profitability.

Profit forecast and investment rating: due to the broad growth hormone market, the rapid growth of new diseases and the continuous expansion of new indications, we maintain the expectation of net profit attributable to the parent from 2022 to 2024 of RMB 4.858 billion, 6.239 billion and 7.720 billion. The current market value corresponds to 14, 11 and 9 times of PE from 2022 to 2024 respectively, maintaining the “buy” rating.

Risk warning: due to the repeated impact of covid-19 epidemic, the review and approval progress is less than expected, and the market promotion progress is less than expected

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