Domestic PD-(L)1 explodes in 2021, and imported drugs face extinction

The previous article detailed the list of domestic PD-1 approvals, which is very popular.
Please refer to: A picture to understand China's PD-1/PD-L1, and the latest analysis is now attached
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We all know that the domestic PD-(L)1 market will be the leader of the Chinese market sooner or later, but it is approaching the end of 2021 that the outbreak of domestic PD-(L)1 has begun.
In 2021, they will surpass imported "KOTI" drugs.
The first year
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01.
Outbreak

In 2021, a total of 24 indications will be approved in China, which exceeds the total number of approved indications in the three years 2018-2020 (20)
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Among them, domestically produced PD-(L)1 monoclonal antibody new indications have been approved to speed up to 17, which quadrupled the number in 2020 (4), and 7 new indications of imported PD-(L)1 have been crushed.
Batch indications
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The domestically produced PD-(L)1 also covers a wide range of tumor types, not inferior to imported KOTI
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Domestic PD-(L)1 approved indications have covered non-small cell lung cancer (NSCLC), esophageal cancer (EC), liver cancer (HCC), nasopharyngeal carcinoma (NPC), MSI-H/dMMR solid tumors, and urothelium Cell carcinoma (UC), classic Hodgkin lymphoma (c-HL), malignant melanoma (MM)

The only tumor types that have not been affected are head and neck squamous cell carcinoma (HNSCC) approved for KO drugs, MPM approved for drug O, small cell lung cancer (SCLC) approved for “IT” drugs, and advanced gastric cancer approved for drug O (GC) These 4 tumor types
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In 2021, 4 new second-tier domestically produced PD-(L)1 will be approved, bringing 4 new indications
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Drug K (Pembrolizumab) won two new first-line indications (advanced esophageal cancer and MSI-H/dMMR metastatic colorectal cancer) in 2021, bringing its first-line treatment indications to 6 and it still ranks first-line No.

Towards the end of 2021, Carrelizumab will start to take the first-line treatment of combined chemotherapy for squamous NSCLC and metastatic esophageal cancer, bringing the number of approved indications to 8, which is the same as K drug for the first time
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Lung cancer is the market with the largest number of approved treatment indications for PD-(L)-1, reaching 16 (including two SCLC treatment indications)
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In 2022, there will be 3 domestic PD-1 and 1 PD-L1 monoclonal antibodies, carrying 7 first-line treatment indications, and "fighting" with KOTI's 7 indications in the locally advanced and metastatic NSCLC treatment market

In the lung cancer treatment market, the first-line treatment of advanced NSCLC is the main battlefield of the domestic and imported PD-(L)1 "fighting"
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In 2022, the K drugs that have won the most NSCLC treatment indications (3) will face 3 domestic PD-1 (carrelizumab, sintilizumab, and tislelizumab), Siege of 1 domestic PD-L1 (suglizumab) and one imported PD-L1 (T drug)

There is no doubt that in 2022, K medicine will face unprecedented strong competition in the NSCLC market
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02, demise

Carrelizumab has surpassed K drug as early as 2020 to become the first-selling PD-1 monoclonal antibody
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Although the impact of Carrelizumab in sales of 10 billion yuan in 2021 has not been achieved (the industry estimates that it will only complete 50%), although the sales of K drug will buck the trend in 2021, the industry estimates that it will still achieve double-digit growth, but There is no doubt that it is a consensus in the industry that immunotherapy is governed by domestically produced PD-(L)1

However, it is not easy to find that the imported PD-(L)1 represented by KOTI is not only being continuously squeezed in its market share, but more importantly, it is losing its leading position in the R&D market in China, and will therefore be completely squeezed.
Lose the advantages of indication registration
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If 2018-2021.
The clinical research of domestically-made PD-(L)1 is still imitating and catching up, then by the end of 2021, we can already see that the clinical research of domestically-made drugs has begun to lead and lead
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In November of this year, Professor Lu Shun from the Thoracic Hospital of Shanghai Jiaotong University reported at the ESMO Asia conference the interim analysis results of the randomized, double-blind, multicenter phase III study ORIENT-31 (NCT03802240), showing that Sintilizumab is combined Bevacizumab biosimilars and chemotherapy for EGFR-positive locally advanced or metastatic non-squamous NSCLC patients who have progressed through EGFR-TKI treatment have obtained significant and clinically significant PFS prolongation
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Last week (December 24), the market application for this indication was accepted by NMPA (acceptance number: CXSS2101085)
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This is the world's first phase III clinical study showing positive results for second-line immunotherapy for patients with EGFR mutation-positive NSCLC
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At the European Society of Medical Oncology (ESMO) conference in September this year, CStone's PD-L1 sugarizumab for the treatment of stage III NSCLC, the randomized, double-blind, placebo-controlled registered clinical study GEMSTONE-301 was selected as ESMO LBA (late-breaking abstract)
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The GEMSTONE-301 study was led by Professor Wu Yilong from Guangdong Provincial People’s Hospital as the main investigator.
The results of the interim analysis published in ESMO showed that sugarizumab as a consolidation therapy can significantly prolong the PFS of patients, whether it is after simultaneous or sequential radiotherapy and chemotherapy.
Of patients have shown clinical benefit and good safety
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This is a benchmark of the famous PACIFIC study in 2017, and it has been extended, that is, patients with concurrent radiotherapy and chemotherapy or sequential radiotherapy and chemotherapy can benefit from PD-L1 consolidation therapy
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On September 2 this year, CStone Pharmaceuticals has submitted a marketing application for this indication

The ORIENT-31 and GEMSTONE-301 studies are led by two leading figures in the treatment of lung cancer in China, and the clinical issues targeted by the studies are at the forefront, with Chinese characteristics, and both defeated KOTI and reported the results of Phase III clinical studies
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There is no doubt that the ORIENT-31 and GEMSTONE-301 research represents a competitive turning point, marking that the domestically produced PD-(L)1 has begun to challenge KOTI’s R&D leadership after taking the leading position in the Chinese market
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Regarding the development of PD-(L)1, domestic experts and national enterprises are no longer satisfied with copying KEYNOTE, CHECKMATE, and IMPOWER research series

This trend has also begun to appear in the treatment fields of esophageal cancer, gastric cancer, liver cancer and so on

The author believes that this is the biggest threat KOTI currently faces in China, and it is likely to accelerate its domestic demise

03.
Stay alive

The key to KOTI's survival in China is to continue to participate in global clinical research, continue to introduce new indications, and do not lag behind the domestic PD-(L)1 in the number of indications and indication coverage.
But it depends.
The recognition of the importance of the Chinese market by the headquarters of multinational pharmaceutical companies and the recognition of the Chinese branch
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AstraZeneca, which supports China the most, is only a "little brother" in the global PD-(L)1 market, while the K and O drugs with the largest number of indications come from two traditional American companies; these two companies Whether it pays enough attention to the Chinese market or gives enough support to the Chinese branch is hard to say, there are big uncertain factors.
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At present, the speed of KOTI's introduction of new indications is slowing down, and the number of approved indications has already been approved.
Was thrown away by the domestic PD-(L)1
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Don't want to sit still, does KOTI still have an advantage on which to survive?

The answer is yes! The basis is not complicated!

KOTI is used to obtain clinical approval early, so compared to the rookies of domestic PD-(L)1, KOTI is bound to have still unique long-term follow-up data for OS and more patients with long-term survival
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Therefore, KOTI should cultivate long-term survival, develop its "die loyal fans" vertically, and shift from a full-line offensive to a strategic defense (or even shrink) to guard against the "die loyal fans", and in this process cleverly use the price points spawned by medical insurance negotiations.
Layer, the PD-(L)1 is divided into two categories.
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and even more artistic, it promotes the involution of the low-end, almost no price difference between the domestic PD-(L)1, and it is closed.
The profit of the fisherman.
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Of course, even if it can do this, it will be difficult for KOTI to recreate its former glory
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However, if you don’t recognize the situation, the pattern, and if you hide your ears and think about it, KOTI is bound to accelerate its demise
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