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 involved in clinical trials, 18 percent of patients with non-small cell lung cancer, 28 percent of patients with melanoma and 27 percent of patients with kidney cancer were relieved, and 66 percent of patients with effective effects 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 were in full swing in China, a year in which China's cross-era drug reform, the opening of the Hong Kong Stock Exchange to non-profit enterprises, the booming biopharmaceutical investment environment, and the competition of hundreds of enterprises on the PD-1/PD-L1 circuit, the hot competition in the field of anti-cancer innovative drugs started the first shot in the domestic pharmaceutical innovation PK field.
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 spends, 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, which is based on pipeline layout, 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-tier 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 recurring 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.
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.
the results of the health care negotiations at the PD-1/PD-L1 circuit determine who will spend the next PD-1/PD-L1 domestic market share.
In terms of commercialization capabilities, IBI308, which has been a Chinese herbal medicine since ancient times, is the first biopharmaceutical company to submit a listing application to CDE for interim data on the recurrence of recurring 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.
(far less than Junshi's 100,000 yuan / year) in the face of such a surge of calm thinking, why the field of anti-cancer innovative 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 mean that the approval conditions are reduced, but under the premise of controllable risk to liberalize 02 anti-cancer drugs non-general drugs, serious 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 have listed 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 PD-1 approval of the matter, 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 metabolized through kidney excretion and liver metabolism, 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 monoantitor for patients with liver and kidney insanity significantly more than the drug-generational dynamics of Terelliju monoanti, Ripley monoanti and xindili monoanti.
03 non-first echelon competitors break out is unlikely, it is recommended that timely adjustment strategy in today's 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.
references: 1, Pabli Pearl Single Anti-Description 2, Tyrrelly Pearl Single Anti-Description 3, Terripley Single Anti-Description 4, Navuliu Single Anti-Description 5, Xindili Single Resistance Manual 6, Akintunde Akinleye, Zoaib Rasool. Immune checkpoint inhibitors of PD-L1 as cancer therapeutics. J Hematol Oncol. 2019; 12: 92.7, Hengrui, Baiji, Thyda, Junshi, PD-1 which strong? Eve / Zhou Jiaxuan / Qian Heng