The first echelon PD-1/PD-L1 immunosuppressant indications become the main battleground.

In 2015, China's pharmaceutical industry introduced a series of heavyweight policies, and the approval process for PD-1/PD-L1 immunocheckpoint inhibitors best represents the changes these policies have brought to the Chinese biopharmaceutical marketJune 2018, the U.S.-owned BMS's Odivo (Navuliu mono-anti-injection) was officially approved by the State Drug Administration (NMPA) for listing, becoming China's first PD-1 monotomaab drug to be listed in the United States, just four years after it was approved for market in the United StatesOver the next two years, China quickly approved seven PD-1/PD-L1 immunosuppressants, including four domestic Ally PD-Ldin the increasingly competitive PD-1/L1 circuit, head drug companies are trying to distance themselves from each other and with the next big forcesGBI will review the current status of PD-1/L1 monoanti-resistation research and development in two sessions, and this issue will provide an overview of the current status of PD-1/L1 antibody drugs developed in ChinaFrom June 2018 to May 2020, a total of 8 PD-1/L1 drugs were approved for the market with NMPA, covering 15 types of indications, 4 of which came from multinational pharmaceutical companies (Table 1)In terms of global trends, in the PD-1/L1 market, companies are trying to take the lead in obtaining an indication l'adylas approval to gain a first-mover advantageBMS heavy PD-1 inhibitor Odivo was the first in China to be approved for treatment of advanced non-small cell lung cancer (NSCLC), followed by approval of head and neck cancer and stomach cancer, gastroesophageal binding cancerThe Meredith (MSD) Coreida (Paboli Zuma) leads the way with four indications, including three NSCLC indicationstwo globally approved PD-1/L1 antibodies that are not yet listed in China, Merck/ElP1 Monoantiba (avelumab) and Sanofi/Reborn PD-1 Monoantio (cemiplimab), were approved by the U.SFDA in March 2017 and September 2018 and are currently undergoing clinical trials in ChinaSince 2014, a total of 54 types of PD-1/PD-L1 inhibitors have been approved by the FDA (see appendix to the full report), of which Corida has been approved for 23 and Odivor has been approved for 16;domestic drug companies initially targeted relatively easy-to-develop successful indications such as classic Hodgkin's lymphoma (cHL) and melanoma, and clinical trials and patient recruitment were relatively smoothSubsequently, the enterprise in other major areas of treatment to adopt a first-mover advantage strategyFor example, Hengrui Pharmaceuticals Erica (Carelli Zhuszina) and Baiji Shenzhou Baczean (TerelliZhumatagain) were approved for the second indicationine in March and April 2020, respectively, for the treatment of advanced liver cell cancer (HCC) and local late or metastatic urethra skin cancer (UC), becoming the first approved HCC and UC PD-1 monotonicathere is no doubt that the domestic PD-1/PD-L1 circuit is now very crowded, but there is still a large number of patients in the country who have never received such treatment, and there is still plenty of room for pharmaceutical companies to developA new study has found that domestic clinical trials treat patients with recruitment rates almost six times as high as in the United States, and four times as high as in the United StatesGBI SOURCE data show that four first domestic PD-1/PD-L1 drugs from the first entry into clinical trials to the first indication saesaw approved for up to 40 months (Hengrui Pharmaceutical Serica), the shortest 27 months (Cinda Bioburshu), Baiji Shenzhou's Baizaian from the start of a clinical trial of non-small cell lung cancer to the application for the indications supplement submission only took less than 20 monthsMultinational companies, unlike multinationals, take 42 to 65 months from the approval of the first clinical trial to the approval of the first indicationsSeptember 2019, the NHSA officially launched the National Health Service directory access price negotiations, and four PD-1 drugs approved by the end of 2018 will have access to the catalogueIn the end, only Cinda Bio/Lilly's Dabershu entered, and the price dropped from 7838 yuan/100mg to 2843 yuan/100mg (about $407.01), a drop of 63.74 percentWhen Dabershu entered health insurance, it improved the drug's patient accessibility in a hospital pharmacyAccording to Lilly, Dabeschu's sales in China were $134 million in 2019 and $57 million in the first quarter of 2020, up from $10 million a year earlierthe newly listed PD-1/L1 inhibitor market is performing relatively strongly even without access to health insuranceAccording to Junshi Bio's financial results, 2019 profit sales of 774 million yuan (about 108 million U.Sdollars), while Hengrui Pharmaceuticals did not disclose Sales of Erika, but estimated to have reached 1 billion yuanBaiji Shenzhou launched The Baizean during the New Crown outbreak in March, generating $21 million in revenue (including pre-orders from distributors) in just a few weeksaccording to public information from Clinicaltrials.gov and ChiCTR.gov.cn, GBI has compiled information on eight approved PD-1/L1 drug programs or ongoing clinical trials in China (see Table 4)As of May 15, 2020, a total of 258 Phase I-III clinical trials are under way in these eight drugsthe largest number of clinical trials for lung cancer, 31%, according to different indications, and stomach cancer and liver/pancreatic cancer were the second and thirdEach of the four domestically produced drugs covers at least six types of indications, of which Hengrui Erika and Junshi Bio-Tooare are the fastest-growing and are conducting clinical trials of eight types of indications (excluding those of unspecified cancer strains)in China's current PD-1/L1 drug submitted in the many indications NDA and sNDA applications (Table 6), lung cancer joint treatment options accounted for the vast majority, the next report will be in detail to explore this aspectIt is worth noting that Junshi Bio-Tuyi's application for this listing of the indications for the second-line or above systemic treatment failure of recurrent/metastatic nasopharyngeal cancer, is expected to become the world's first approved of this indication pD-1 drug .