Review of new drug market this week: from March 14, 2022 to March 18, 2022, the top 5 enterprises in the new drug sector: kangnaide (59.2%), Geli Pharmaceutical (52.9%), Hualing Pharmaceutical (19.4%), Tianjing Biology (16.9%), Hehuang Pharmaceutical (15.2%); The top 5 enterprises with decline: konoya (- 29.8%), Genxi Biology (- 14.9%), jiakesi (- 4.4%), Baiji Shenzhou (- 3.9%) and Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) (- 3.8%).
Key analysis of new drug industry this week:
This week, Pfizer covid-19 oral drug MPP authorization was officially launched. On the evening of March 17, MPP (Geneva pharmaceutical patent pool organization) officially announced that 35 enterprises around the world have obtained Pfizer covid-19 oral drug authorization, including two enterprises Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) and Shanghai Desano, as well as five enterprises Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) , Apeloa Pharmaceutical Co.Ltd(000739) and Jiuzhou pharmaceutical. MPP grants the above-mentioned enterprises a non exclusive license to use relevant patents and know-how to produce the generic drug and licensed product “paxlovid therapy” of oral covid-19 therapeutic drug “nirmatrelvir”, and commercialize licensed products and related rights in the region (i.e. 95 low-income countries such as India, Pakistan and C ô te d’Ivoire).
In China, recently, paxlovid therapy has also been written into the ninth edition of covid-19 treatment plan of the latest edition of the National Health Commission; In addition, according to the Shanghai Securities News, on the evening of March 17, 21200 boxes of “pamatovir / ritonavir tablets” (paxlovid) have been transported to all parts of the country after being checked and released by the customs, which is the first batch of imports since the drug was included in the latest version of covid-19 pneumonia diagnosis and treatment program.
The self-control of covid-19 therapeutic drugs is the top priority in the prevention and control of covid-19 epidemic in China. At present, many enterprises in China have arranged domestic covid-19 therapeutic drugs, which are expected to be available in each treatment stage of mild, moderate and severe diseases, covering multiple drug types such as small molecules and large molecules. For the treatment of patients with mild to moderate diseases, among the varieties independently developed in China, azvudine (phase 3), vv116 (phase 2 / 3) of Shanghai Junshi Biosciences Co.Ltd(688180) / Chinese Academy of Sciences / Wangshan wangshui and fb2001 (phase 1) of Frontier Biotechnologies Inc(688221) . According to the current progress, azvudine and vv116 are expected to read out key clinical data by the middle of this year; In terms of treatment of severe patients, prochloramide (phase 3), plonmarlimab (phase 2 / 3), stsa-1002 (phase 1) of Staidson(Beijing) Biopharmaceuticals Co.Ltd(300204) and so on, which have made rapid clinical progress. Most of other drugs under research are in preclinical development stage, but many drugs are expected to enter later clinical trials in 2022.
Approval & acceptance of new drugs this week:
This week, 4 new drugs or new indications of new drugs were approved for listing in China, 31 new drugs were approved ind, 21 new drugs ind and 3 new drugs NDA were accepted.
Top 3 of China’s new drug industry this week focuses on:
(1) on March 16, Shanghai Junshi Biosciences Co.Ltd(688180) released the phase I clinical data of vv116 for the first time, which is also the first time that domestic oral small molecule anti sars-cov-2 drugs released clinical data. The data showed that in healthy subjects, vv116 showed satisfactory safety and tolerance, and was absorbed orally rapidly. It can be taken orally under fasting or ordinary diet conditions. It is suggested to explore further dosage in the later stage. The results have been published in Acta Pharmaceutica Sinica.
(2) on March 16, Shanghai Junshi Biosciences Co.Ltd(688180) vv116 completed an international multicenter, randomized, double-blind phase 3 clinical study. The first patient was enrolled and administered. This clinical study aims to evaluate the efficacy and safety of vv116 compared with standard treatment in moderate and severe covid-19 subjects. At present, vv116 has been approved in Uzbekistan for the treatment of moderate and severe covid-19 patients.
(3) on March 14, Fuhong Hanlin disclosed the results of phase 1 clinical trial of hlx71. The 1 phase clinical trial showed that the ACE2-Fc receptor fusion protein HLX71 was safe and well tolerated in the treatment of New Coronavirus pneumonia. At the same time, there was no dose limiting toxicity (DLT) in the test, and there was no new safety signal in the study.
Top 3 of overseas new drug industry this week focuses on:
(1) on March 18, BMS announced that FDA approved its innovative “first in class” therapy opdualag to be listed. This therapy consists of a fixed dose of relatlimab, an anti-lag-3 antibody drug, combined with opdivo (nivolumab), an anti-PD-1 antibody. It is used to treat adults and children (12 years and older) with unresectable or metastatic melanoma. It is reported that relatlimab is the first LAG-3 antibody approved by FDA and the first innovative cancer immunotherapy approved for new immune checkpoints in recent 10 years. (2) On March 19, marinus announced that FDA had approved the listing of ztalmy (ganaxolone, ganesolone) oral suspension. In patients over two years of age, it is used to treat seizures associated with cyclin dependent kinase like 5 (CDKL5) deficiency (CDD). It is reported that the drug is a positive allosteric modulator of GABAA receptor for the treatment of this rare hereditary epilepsy. It is also the first FDA approved treatment for this patient population.
(3) on March 17, Lilly and Boehringer Ingelheim jointly announced the early termination of the phase 3 clinical trial of SGLT2 inhibitor empagliflozin in patients with chronic kidney disease (CKD) based on the recommendations of the independent data monitoring committee. In the interim analysis, the trial met the pre-set criteria for positive efficacy.
Risk warning: the risk that the progress of clinical trials is less than expected, the risk that the results of clinical trials are less than expected, and the risk of changes in medical policies.
