The first echelon of PD-1/PD-L1 immunosuppressant adaptation becomes the main battleground.

In June 2018, U.S.-owned BMS's Odivo (Navuliyu single-dose injection) was officially approved for listing by the State Drug Administration (NMPA), making it China's first PD-1 single-anti-drug drug, just four years after it was approved for sale in the United States.
two years, China quickly approved seven PD-1/PD-L1 immunosuppressants, including four domestic PD-1 monoantigens.
in the increasingly hotly contested PD-1/L1 circuit, head drug companies try to distance them from each other and from the next big forces.
GBI will review the status quo of PD-1/L1 monoantibody research and development twice, and this issue will provide an overview of the current status of PD-1/L1 antibody drugs developed in China.
01, the first batch of approved PD-1/PD-L1 immunosuppressants from June 2018 to May 2020, a total of 8 PD-1/L1 drugs were approved for the market by NMPA, covering 15 adaptations, 4 of which came from multinational pharmaceutical companies (Table 1).
from a global perspective, in the PD-1/L1 market, companies are trying to take the lead in obtaining approval for an adaptation to gain a first move advantage.
BMS heavy PD-1 inhibitor Odivo was first approved in China for the treatment of advanced non-small cell lung cancer (NSCLC), followed by approval of head and neck cancer and stomach cancer, gastroesophageal combined cancer adaptation.
(MSD) led the way with four adaptation approvals, including three NSCLC adaptations.
two PD-1/L1 antibodies approved worldwide but not yet listed in China, Merck/Pfizer's PD-L1 single-resistant Bavencio and Sanofi/Recycled PD-1 single-anti-Libtayo (cemiplimab), were approved for listing by the FDA in March 2017 and September 2018 and are currently undergoing clinical trials in China.
Since 2014, 54 adaptations of PD-1/PD-L1 inhibitors have been approved by the FDA (see appendix to the full report), of which 23 have been approved by Corida and 16 by Odivo;
02, domestic pharmaceutical companies show China's speed advantage Domestic pharmaceutical companies initially targeted classic Hodgkin's lymphoma (cHL) and melanoma and other relatively easy to develop successful adaptations, and clinical trials and patient recruitment is relatively smooth.
, companies adopted a first-mover strategy in other major therapeutic areas.
For example, Henrui Pharmaceuticals Erika (Karelli Pearl Monomason) and Baiji Shenzhou Baizean (Tyreli Pearl Monomason) were approved for the second adaptive disease in March and April 2020, respectively, for the treatment of advanced hepatocellular carcinoma (HCC) and local late stage or metastatic urethra cancer (UC), becoming the first HCC and UDPD-1 monomatode in China.
there is no doubt that the domestic PD-1/PD-L1 circuit is now very crowded, but there are still a large number of patients in the country who have never received such treatment, pharmaceutical companies still have a lot of room for development.
study found that patients treated with monodring in domestic clinical trials are recruiting almost six times as many patients as in the United States, and combined therapy is four times as likely as in the United States.
GBI SOURCE data show that the first batch of domestic PD-1/PD-L1 drugs took up to 40 months from the first entry into clinical trials to the approval of the first adaptive disorder (Henri Pharmaceuticals Erika), the shortest of which was only 27 months (Cinda Bio Dabershu), and less than 20 months from the launch of a clinical trial of scaly non-small cell lung cancer to the submission of the adaptation supplement.
from multinational companies, it took 42 to 65 months from the approval of the first clinical trial to the approval of the first adaptation.
03, the new version of the health insurance catalogue brings benefits in September 2019, the National Health Service (NHSA) officially launched the National Health Insurance Directory access price negotiations, the end of 2018 approved four PD-1 drugs will have access to the list.
only Xinda Bio/Lilly's Daboshu entered, and the price dropped from 7,838 yuan/100mg to 2,843 yuan/100 mg (about $407.01), a drop of 63.74 percent.
access to the drug in hospital pharmacies was improved after Mr. Daboshu entered health insurance.
according to Lilly, Dabershu's sales in China were $134 million in 2019 and $57 million in the first quarter of 2020, up from $10 million a year earlier.
the market for newly listed PD-1/L1 inhibitors is relatively strong, even if they are not covered by health insurance.
According to Junshi Bio,2019 sales were 774 million yuan (about $108 million), while Hengrui Pharmaceuticals did not disclose Erica's sales, but estimated to have reached 1 billion yuan.
, which launched Bazean during the new crown outbreak in March, generated $21 million in revenue in just a few weeks, including pre-orders from distributors.
06, Clinical Development Trends According to public information from Clinicaltrials.gov and ChiCTR.gov.cn, GBI has compiled information on eight approved PD-1/L1 drug programs or clinical trials under way in China (see Table 4).
as of May 15, 2020, there are 258 phase I.-III. phase China clinical trials underway for these eight drugs.
, lung cancer had the highest number of clinical trials, at 31 per cent, and stomach and liver/pancreatic cancers at 18 per cent and 10 per cent, respectively, ranking second and third.
Each of the four domestically produced drugs covered at least six indications, of which Hengrui Erica and Junshi Biotoyme were the fastest-growing in research and development, and clinical trials of 8 indications were under way (excluding indications of unspecified specific cancer species).
08, the upcoming approval of the listing application in China's current PD-1/L1 drug submitted a large number of adaptive NDA and sNDA applications (Table 6), the joint treatment of lung cancer accounted for the vast majority, the next report will explore this aspect in detail.
it is worth noting that Junshi Biotoyi's application for this listing of the adaptive disease for second-line or above systemic treatment failure of relapsed /metastatic nasopharyngeal cancer, is expected to become the world's first approved PD-1 drug for this adaptation.
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