Changchun High-tech (000661): Investing in overseas dual-antibody platforms, lidocaine transdermal patch innovation pipeline layout is becoming increasingly rich

Changchun High-tech (000661): Investing in overseas dual-antibody platforms, lidocaine transdermal patch innovation pipeline layout is becoming increasingly rich
Events: (1) The company announced that it has signed an agreement with Antai Pharmaceuticals to invest no more than 62 million yuan to purchase the “5% Lidocaine Transdermal Patch” sales rights and global production rights in mainland China. (2) The company announced that it plans to establish an antibody platform joint venture with Amesino in the United States.Among them, Amesino holds 80% equity, Changchun Gaoxin invested 30 million yuan, and holds 20% equity. Comments: (1) 5% lidocaine patch (LMP) is a polyester patch containing lidocaine 700 mg, 10 cm x 14 cm in size, which blocks damaged C fibers through local diffusion of lidocaineThe barrier effect of sodium channel of Aδ fiber and patch achieves analgesic effect.LMP is recommended by the European Medicines Agency and the US FDA as a first-line treatment for postherpetic neuralgia, especially for patients who cannot tolerate systemic drugs, such as renal insufficiency.LMP is also recommended for other local neuropathic pain.In 2018, the national local anesthesia market was nearly 1 billion US dollars, especially drugs such as rocaine, lidocaine and tetracaine.Lidocaine 2018 PDB Sample Hospital Sample 1.1 ppm, an increase of 67% before 2017, most of which are injections and capsules. Only Beijing Tide Pharmaceutical Factory was approved for lidocaine gel patch. Such products were listed in the year when it was launched in 2018.40,000 yuan, 19H1 budget of 20,000 yuan, good growth momentum.There is currently no 5% lidocaine transdermal patch on the market in China. Anengtai Pharmaceutical has developed NAL1282 Lidocaine 5% patch.The company and Anengtai Pharmaceutical plan to jointly build a hydrogel patch pharmaceutical strategic production base and a hydrogel patch pharmaceutical laboratory in Changchun. Changchun High-tech is responsible for purchasing related instruments and equipment. Anengtai Pharmaceutical is responsible for upgrading the production baseGMP certification and production licenses that meet the requirements of the US FDA, EU EMA, China NMPA and global requirements.After the product is launched, Changchun High-tech is responsible for regional sales in China, and Anengtai Pharmaceutical is responsible for overseas regional sales.In the long run, the company will use the platform technology of transdermal patch preparations as an entry point to imitate and combine innovations to develop improved new drugs for transdermal preparations. (2) Bispecific antibody drugs are one of the most popular directions in the field of tumor immunotherapy in the world. At present, only three diabody antibody drugs are on the market, and domestic dual antibody projects are in the IND 南京桑拿网 or early clinical stage.The proposed antibody platform joint venture company will first select known targets for secondary development and speed up product development. Subsequently, it will develop recombination and innovative new target bifunctional antibody drugs. Earnings Forecast and Estimate: Maintain forecast for EPS 7 of 19-21.95/10.48/13.73 yuan. After the restructuring, the EPS after diluted for 19 years is 8.99 yuan (corresponding to 38X / 28X in 19-20 years).The company’s stock exchange has been steadily advancing. The current performance is highly compatible with the estimates, and the rating of “Buy” is maintained. Risk warning: uncertainty in the progress of the stock exchange; the progress of new product development is not up to expectations.