Three new class 1 drugs are expected to be approved one after another, and hausen's valuation is expected to rise to HK $65 billion

May 17, medical network recently, the State Food and Drug Administration announced that the first class of new drug, pegylated loseptide injection (trade name: Flemish), was approved for marketing through priority review to improve the blood glucose control of adults with type 2 diabetes It is reported that this product is the first innovative drug in the field of diabetes by Howson pharmaceutical Howson pharmaceutical recently updated the prospectus of Hong Kong stock listing, which refers to the introduction of a new investor Boyu fund on January 25, 2019 to obtain $248 million in strategic financing After the completion of the financing, the valuation of Howson pharmaceutical rose to HK $65 billion It is estimated by the insiders that the market value of hausen pharmaceutical industry may reach 100 billion after listing What breakthroughs has hausen pharmaceutical made in the past year? Three new drugs of category 1 have been applied for listing, and the leading position of anti-tumor is expected to be improved Table 1: new drugs applied for listing by hausen pharmaceutical industry since 2018 (medchina drug review database 2.0 of minenet) According to the data of minenet, the application for listing of pegylated loseptide injection was included in the priority review on December 6, 2017, and approved for production on May 7, 2019, lasting for more than 500 days At present, there are still two new drugs of anti-tumor and immunomodulator applied for listing in hausen pharmaceutical industry Flumatinib mesylate has been included in the priority review on July 20, 2018 This product is the second generation BCR ABL TKI; ometinib mesylate mesylate is mainly used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients, mainly for the EGFR T790M drug-resistant mutation At present, the latest status of the above two products is under review and approval Table 2: the ranking of hausen pharmaceutical in the public hospital terminals of key provinces and cities in 2018 (the competition pattern of the public hospital terminals of key provinces and cities of mienei.com) The drug pipeline of hausen pharmaceutical focuses on six treatment fields: central nervous system disease, anti-tumor, anti infection, diabetes, Xiaohua Road and cardiovascular According to the data of minenet, in 2018, in the public hospital terminals of key provinces and cities, hausen pharmaceutical industry has made outstanding performance in four major fields, among which, it ranked in the top ten in the market of psychotranquilizers and antineoplastic drugs With the subsequent approval of flumatenib mesylate and ometinib mesylate mesylate, hausen pharmaceutical industry will increase its anti-tumor field and further improve its market leadership Rise 7 major products have passed the consistency evaluation, and 6 injection supplement applications are under review Table 3: products that have passed (or are deemed to have passed) the consistency evaluation of hausen Pharmaceutical (medchina drug evaluation database 2.0 of minenet) As of May 16, 2019, there are 7 products that have passed or are deemed to have passed the consistency evaluation by Howson pharmaceutical industry, among which only Howson pharmaceutical has passed the evaluation of repaglinide, imatinib mesylate, procapride succinate, wiggliptin and apixaban At present, the supplementary application for conformity assessment of Qilu Pharmaceutical Co., Ltd is under review and approval In the 4 + 7 volume purchase, the two over evaluated products of hausen pharmaceutical, imatinib mesylate tablets and olanzapine tablets, were both successful in winning the bid The bid price of imatinib mesylate tablets (100mg * 60 Tablets / box) was 623.82 yuan, and olanzapine tablets (10mg * 7 tablets / box) was 67.51 yuan Table 4: application for consistency evaluation of Haosen pharmaceutical industry in review (medchina drug review database 2.0 of minenet) Most in the industry think that the consistency evaluation of injections is "difficult to achieve" Up to now, there are 9 injections that have passed or are deemed to have passed the consistency evaluation In 2017, cefazolin / sodium chloride injection and pemetrexed disodium for injection were approved; in 2018, azithromycin, flurbiprofen axetil injection, dexmedetomidine hydrochloride injection and injection were approved Paclitaxel (albumin binding type) and ibuprofen injection for injection; temozolomide and docetaxel injection for injection were approved in January 2019 In recent months, there has been no new injection evaluation information, and 8 of the above 9 products have been registered and approved according to the new classification as passing the consistency evaluation It can be seen that the national level is more and more strict in the evaluation of injection consistency At present, there are 7 products involved in the supplementary application for consistency evaluation of hausen pharmaceutical, among which 6 are injection and 1 is cefdinir capsule In 2018, the terminal sales of the above products in public hospitals in key provinces and cities exceeded RMB 100 million, including 1.61 billion of pemetrexed disodium for injection, 700 million of tegacyclin for injection, 660 million of gemcitabine hydrochloride for injection and 540 million of linezolid glucose injection Nine four kinds of generic drugs are under review, and the competition for the first generic drugs of six products is fierce Hausen pharmaceutical industry has been engaged in the field of generic drugs for many years, and has launched more than 30 kinds of first generic drugs in China so far Up to now, five generic drugs have been approved for production in 2018, including procapride Succinate Tablets and alisentan tablets, and six types of generic drugs, including viagliptin tablets, apixaban tablets and micafungin sodium for injection According to the one key search on the intranet, domestic manufacturers of procapride succinate and apixaban tablets are now Only hausen pharmaceutical has obtained the approval document The domestic manufacturers of alisentan tablet include hausen pharmaceutical and Zhengda Tianqing, the domestic producers of wigletin tablet include hausen pharmaceutical and Qilu pharmaceutical, and the domestic producers of micafungin sodium for injection include hausen pharmaceutical and Haizheng pharmaceutical Table 5: the situation of four generic drugs under review by hausen Pharmaceutical (medchina drug review database 2.0 on minenet) up to now, there are still nine four generic drugs in hausen pharmaceutical industry that are applying for listing, involving three treatment fields Among the anti-tumor and immunomodulators, apart from the approval of lenalidomide capsule by Beijing Shuanglu Pharmaceutical Co., Ltd., Zhengda Tianqing Pharmaceutical Co., Ltd and Qilu Pharmaceutical Co., Ltd., there are no domestic enterprises approved for alfatinib maleate tablets, sunitinib malate capsules and erlotinib hydrochloride tablets Among the nervous system drugs, olanzapine orally disintegrating tablets have been approved by Qilu Pharmaceutical Co., Ltd., while palliperenone sustained-release tablets have not been approved by domestic enterprises Among the digestive system and metabolic drugs, there are no domestic enterprises approved for engliptin tablets and kagliptin tablets The domestic enterprises of shagliptin tablets have been approved by Jiangsu aosaikang Pharmaceutical Co., Ltd Table 5: enterprises competing for the first copy of six products (MED China drug review database 2.0 on minenet) At present, there are many domestic giants competing for the first copy of the six products Kelun, Zhengda Tianqing, Ouyi, xinlitai, etc are all involved in the competition, and who will win or lose the competition? We are waiting for the good news The above products are all declared according to the new registration classification of chemicals Once approved, they will be included in the list of drugs listed in China, and will be deemed to have passed the consistency evaluation Conclusion: after the first Hong Kong stock offering document was submitted in September 2018, hausen pharmaceutical has gone all the way On April 11, 2019, the prospectus was updated again It was mentioned that on January 25, 2019, a new investor Boyu fund was introduced to obtain US $248 million strategic financing The latest valuation of hausen pharmaceutical reached HK $65 billion Industry insiders predict that Haosen pharmaceutical industry is expected to advance to a market value of 100 billion after listing.