PD-1/PD-L1 Re-entered Health Insurance China's innovative pharmaceutical company research and development and commercialization capabilities big PK

PD-L1 and PD-1 are the relationship between the mating body and the subject, after the identification and binding, T cell activity is inhibited and the original killing effect is lost, the tumor can grow.
immunosuppression point single anti-drug PD-1/PD-L1, by specific binding to PD-L1 on tumor cells or PD-1 on T cells, to remove the tumor cells on the function of T cells inhibition, restore the body's own immune system to the tumor cells accurate identification and killing.
May 2012, the New England Journal published the results of a clinical trial of PD-L1 antibody MDX1105, the world's first clinically-staged PD-1/PD-L1 antibody.
of patients who participated in clinical trials, 18 percent of patients with non-small cell lung cancer, 28 percent of melanoma patients and 27 percent of patients with kidney cancer were relieved, and 66 percent of patients with effectiveness continued for more than a year.
this stunning clinical outcome has attracted unprecedented industry attention to PD-1/PD-L1.
In 2018, as the seed player of the anti-cancer innovation drug circuit- O-drug and K-drug approval and listing in China is in full swing, this year, China's cross-era drug reform, the opening of the Hong Kong Stock Exchange to non-profit enterprises, the bio-pharmaceutical investment environment is booming, as well as hundreds of enterprises in the PD-1/PD-L1 track competition, the hot competition in the field of anti-cancer innovative drugs started the first shot of domestic pharmaceutical innovation PK.
the first echelon of the domestic me too ranks: Xinda, Junshi, Hengrui and Baiji Shenzhou PD-1/PD-L1 research and development layout gradually clear.
back to 2020, PD-1/PD-L1 monoclonal antibody (mAb) drugs have become the standard treatment for 16 different types of cancer.
from the domestic innovative pharmaceutical enterprise battlefield, the title of better in the end who spent home, is expected to be from Xinda, Junshi, Hengrui, Baiji Shenzhou four first echelons.
is not only a comparison of the layout strategy and clinical research and development strength of the adaptation, but also the commercialization ability - the strength of the price and health care negotiations.
IBI308 of Xinda Bio is the first biopharmaceutical company to submit a listing application to CDE for interim data on the recurrence of recurring incurable Hodgkin's lymphoma Phase II clinical.
as the winner of the 2019 PD-1/PD-L1 health care negotiations, Cinda Bio is the only pharmaceutical company in China with a second-line layout of squamous cancer in the field of non-small cell lung cancer.
Bio is the first biopharmaceutical company to file a listing application with CDE for interim data on the recurring incurable Hodgkin's lymphoma Phase II clinic.
as the winner of the 2019 PD-1/PD-L1 health care negotiations, Cinda Bio is the only pharmaceutical company in China with a second-line layout of squamous cancer in the field of non-small cell lung cancer.
advantage of Baiji Shenzhou is that it is the first company in China to deploy a global multi-center clinical trial of PD-1 single resistance at the same time.
it is also an area of adaptation with a large focus on patients, and has a first-in-the-first advantage in some large varieties.
such as in the field of urethra skin cancer baiji Shenzhou has been approved.
addition, the BGB-3111 clinical data in Baiji Shenzhou performed well and is expected to be the PD-1 monomass of Better or Best worldwide.
advantage of Hengrui Pharmaceuticals is that the pipeline layout is the most comprehensive, the most prominent sales capacity, NSCLC, esophageal cancer and liver cancer clinical trials are its focus.
because of the large market size of these three tumor varieties and the high incidence rate in China, the side reflects the clear thinking of Hengrui Pharmaceuticals in the clinical trial planning of SHR-1210.
as the country's first PD-1/PD-L1 approved for the market, the choice is the domestic incidence of low incidence and clinical lack of direct treatment of the adaptive disease - melanoma.
so junshi creatures in the "cold" field of adaptive diseases quickly approved, and many times to obtain orphan drug qualifications.
November 11, the State Administration of Health Care Security issued the "Announcement on the 2020 National Health Insurance Drug Catalog Adjustment Expert Review Results Inquiry", prompting the expert review phase of the work to be completed, bidding negotiations will be organized in accordance with the procedures.
means that the market's high-profile negotiations and bidding curtain is about to open.
and the outcome of the health care negotiations at the PD-1/PD-L1 circuit determines who will take the next crown of the PD-1/PD-L1 domestic market share.
IBI308, which has been a Chinese herbal medicine since ancient times in terms of commercialization capabilities, is the first biopharmaceutical company to submit a listing application to CDE for interim data on the recurrence of recurring incurable Hodgkin's lymphoma phase II clinical.
as the winner of the 2019 PD-1/PD-L1 health care negotiations, Cinda Bio is the only pharmaceutical company in China with a second-line layout of squamous cancer in the field of non-small cell lung cancer.
in terms of commercialization capabilities, Hengrui Pharmaceuticals' overwhelming advantage in this health care negotiation cannot be underestimated.
although the resuscant Ripley single resistance had a price advantage last year and was favored.
this year, the price advantage is gradually being lowered.
same time, because the number of new cases of melanoma in China in 2019 was 7,563, the incidence rate is low, in 2019, the number of new melanoma patients after the failure of standard treatment of local progression or metastasis melanoma patients only 2,400 people, the corresponding market size is small.
's Tripley single resistance in the report card, in the three quarters of 2020 to achieve cumulative sales revenue of more than 800 million yuan.
as a successor, Hengrui Medicine has a good performance.
, according to IQVIA data, in the first half of this year, Hengrui Pharmaceutical's Karelli Pearl single-resistance sales of more than 2 billion yuan, accounting for nearly 40% of the market share.
this is still in the absence of health insurance, the main channel of sales should be outside the hospital.
The reason, on the one hand, Hengrui pharmaceutical tumor line sales staff of more than 6000, of which PD-1 full-time sales staff will be close to 2000 people, is the size of other sales team twice or more, a large sales force for the rapid and large-scale spread of products to provide the most important support.
, on the other hand, Hengrui Pharmaceuticals' rapid deployment of medical team expansion and digital marketing transformation are clearly well-positioned to take the market dominance of the PD-1/PD-L1 circuit.
What makes Hengrui more like bamboo is that the quotation "floor price" of the Karelli Pearl single resistance has a great negotiating win face, on October 25, Hengrui Pharmaceuticals announced that the Carelli Pearl single resistance price will be reduced to 30,000 yuan / year.
(well below Junshi's 100,000 yuan/ year) In the face of such a surge of rapids, we calmly ponder why the field of cancer innovation drugs in China can appear in a state of white heat? Is the new drug too good research and development, or China has such research and development strength of pharmaceutical companies are no longer in the minority? On the one hand, priority approval brings policy boon, on the other hand, patients and the market eagerly awaited the PD-1/PD-L1 research and development boom.
, despite the boom, we should look at the following three aspects rationally.
01 Priority approval does not represent a reduction in approval conditions, but on the premise of risk control to open up in order to encourage research with clinical and necessary innovative drugs, effectively control risks, solve the backlog of approval, the State Food and Drug Administration has promulgated the "special approval and management regulations for the registration of new drugs" "breakthrough treatment drug review procedures (trial)" "drug conditional approval and approval procedures (trial)" "drug market licensing priority review and approval procedures (trial) and so on."
it provides that new drugs for the treatment of AIDS, malignant tumors, rare diseases and other diseases and have obvious clinical treatment advantages;
the varieties to be included in the priority review will be made public on the website of the State Drug Administration.
107 listing applications were formally included in the priority review in the first half of 2020 alone.
02 anti-cancer drugs are not general drugs, heavy disease drugs, need to objectively look at adverse reactions each drug has its adverse reactions, and because of individual differences, each person produced side effects are different.
we need to look at the benefits and risks of anti-tumor drugs correctly.
immunotherapy has better therapeutic results, as evidenced by the broader spectrum of anti-cancer effects of immunotherapy; immunotherapy has far fewer overall side effects than chemotherapy; and immunotherapy, if effective, may allow advanced patients to survive long-term, or even clinically cure, which is the biggest difference between immunotherapy and all other drugs.
At the same time, the most commonly affected areas of the body in patients receiving checkpoint inhibitors are the skin, colon, endocrine system, liver, lungs, heart, musculoskeletal system and central nervous system.
Based on publicly available information, we list the safety of several PD-1 drugs: among the adverse reactions of PD-1 products, the most common are those that cause dermatitis, erythema, allergies, etc., which are called first- or second-level adverse reactions.
in international law, this needs to be recorded, but it is not considered to affect security.
said that the rate of adverse reactions is high, does not have a reference value, but to compare the severity of adverse reactions.
are also side effects of PD-1 products, some cause dermatitis, some cause vascular growth, in the field of medicine, simple comparison can not explain anything.
guidelines for the rate of non-performing biopharmaceuticals.
, for example, dermatitis does not affect drug safety assessment in adverse reactions to PD-1, but is absolutely not allowed in OTC products.
PD-1 drug treatment is tumor, several domestic pharmaceutical companies are reported for rare tumor diseases, in the premise of no cure, supervision is more considered is the social risk benefits.
in the matter of PD-1 approval, the so-called conditional approval, is the drug regulator for emergency products or incurable diseases opened a green channel.
is it necessary to evaluate the safety of patients with liver and kidney injuries before approval? In PD-1 drugs, this is not a required item.
We know that many small molecule drugs are excreted through the kidneys and metabolized by the liver, and if the patient's liver and kidneys are not fully functioning, this may lead to a decrease in drug clearance rates, which in the body accumulates toxicity.
and PD-1 inhibitors belong to the polymer drug, not excreted through the liver and kidneys, pharmacodynamic data also show that renal insinsecretion does not affect the removal rate of PD-1 inhibitors, so in theory, patients with renal insevent can use PD-1 inhibitors, but still need clinical data to demonstrate.
we compared the description of liver and kidney insysophthalmation in five PD-1 monoants.
it can be seen that the drug generational dynamics of Navuliyu monoanti and Pabliju monoanti for patients with liver and kidney insanity significantly more than the drug-generational dynamics of Terelliju monoanti, Terripri monoanti and xindili monoanti.
03 non-first echelon competitors break out is unlikely, it is recommended that timely adjustment strategy in today's case with volume procurement strict control into the hospital, non-first echelon of enterprises if you want to rely entirely on funds and repeat the existing research and development ideas in the PD-1 competition breakout, the difficulty can be said to be very great, and cost-effective is not high, should carefully consider timely stop loss.
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