Domestic anti-cancer drugs add a new army! Zhengda Tianqing androtinib was approved. Who is the strong target drug market for lung cancer?

Recently, the National Drug Administration approved the launch of small molecule and multi-target receptor tyrosine kinase inhibitor androtinib hydrochloride capsule (focovide) for the treatment of advanced or metastatic non-small cell lung cancer Enrotinib hydrochloride capsule is an innovative drug independently developed in China, and has been approved for marketing through the priority review and approval process In April 2017, Zhengda Tianqing submitted the production application of anlotinib hydrochloride capsule to its approval, which took one year and attracted the attention of the industry Of course, this is not the first product to benefit from the priority review channel It took only 8 days for the 9-valent HPV vaccine of MSD to go on the market from application to approval, and its priority review process was promoted rapidly, which set a new record On April 20, the 9-valent HPV vaccine of mosadong was submitted for new drug application Three days later, it was included in the 28th batch of priority review catalogue by CDE On April 28, CDE approved the conditional listing The next month, the first nine price HPV vaccine supplement procurement landed in Hainan On May 10, Hainan Provincial Public Resources Trading Center issued a notice, and Hainan provincial CDC added it to the shortlist of procurement, and asked its manufacturer, MSD's agent, Zhifei biology, to conduct price negotiations the next day On May 11, the result of price negotiation came out Nine price HPV vaccine (two packages) 1298 yuan each Obviously, the achievements brought by the implementation of the priority review system are gradually emerging The opinions on solving the backlog of drug registration applications and implementing priority review and approval issued at the beginning of 2016 marks the formal implementation of priority review system in China In October 2017, the general office of the State Council officially issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices, again mentioning the need to speed up the review and approval In the past two years, as of publication, CDE has released a total of 28 batches of drug registration applications included in the priority review process, including enrotinib hydrochloride capsule and 9-valent HPV vaccine The reason for the priority evaluation of 9-valent HPV vaccine is that it has obvious clinical advantages, and the capsule of enrotinib hydrochloride also has obvious treatment advantages compared with the existing treatment methods Looking at the domestic and foreign lung cancer market, in the past few years, the global lung cancer treatment has made significant progress, new targeted treatment drugs continue to come out, bringing a leap forward in lung cancer treatment Multinational pharmaceutical giants have long coveted China's huge lung cancer treatment market Facing the impact of foreign heavyweight drug market, domestic enterprises should think about how to deal with it, so as to quickly enter the market and seize the high-end market share of lung cancer According to the 2018 cancer statistics in the United States, lung cancer is the second leading cause of cancer and incidence rate of death It is a major killer that human life and health can not be ignored NSCLC is the most common type of lung cancer, accounting for about 85% of lung cancer patients According to the report of the World Health Organization, there are 1.8 million new lung cancer patients and 1.6 million deaths every year in the world According to the statistics of global best-selling drug data, in 2017, seven monoclonal antibody drugs have been listed abroad The sales are as follows: 7.141 billion US dollars of bevacizumab of Roche, 5.767 billion US dollars of navumab of Bristol Myers Squibb, 3.809 billion US dollars of permumab of mosadong, 1.244 billion US dollars of epimumumab of Bristol Myers Squibb, 758 million US dollars of rimoru of Lilly, 477 million US dollars of tecentriq of Roche and 19 million US dollars of imfinzi of AstraZeneca The total sales of the above seven products amounted to US $19.2 billion, of which the two products with rapid growth are: opdivo (namuwumab) of Bristol Myers Squibb and keytruda (pymrumab) of MSD The sales volume of TiNi drugs on the market in foreign countries are respectively: US $955 million for ositinib of AstraZeneca, US $891 million for erlotinib of Roche, US $595 million for clozatinib of Pfizer, US $527 million for gefitinib of AstraZeneca and US $362 million for eletinib of Roche The faster growing product is AstraZeneca's tagrisso In 2017, the global sales of lung cancer targeted drugs reached nearly 24 billion US dollars The first-line lung cancer label of PD-L1 > 50% has been obtained by keysrud, the PD-1 antibody of MSD, which covers about 25% of patients In April 2018, MSD announced that keytruda has significantly improved PD-L1 > 1% of patients' survival compared with platinum chemotherapy drugs in a phase III clinical mid-term analysis If this population enters the label, it can increase the first-line application population of keytruda to 70%, which will further consolidate the dominant position of MSD keytruda in lung cancer, the most important market The performance of new products in the domestic market is good According to the data statistics of domestic sample hospitals, in 2017, the sales volume of bevacizumab of Roche, a monoclonal antibody drug, reached 570 million yuan, an increase of 30.90% over the same period The product has maintained a rapid growth since its launch There are 6 TiNi drugs on the market in China, and the amount of drug used in sample hospitals is: The sales volume of AstraZeneca and Qilu's gefitinib is 419 million yuan; the sales volume of Beida ektini is 298 million yuan; the sales volume of Pfizer kztinib is 98.16 million yuan; the sales volume of Roche erlotini is 96.43 million yuan; the sales volume of AstraZeneca oshitini is 9.18 million yuan; the sales volume of bolingyingehan afatini is 160000 yuan In 2017, foreign lung cancer heavyweight drugs successively landed on the domestic market, namely, ositinib of AstraZeneca and afatinib of bringer Ingelheim In the future, oxitinib and afatinib will be potential blockbuster drugs for lung cancer target drug market in China Oxytinib was developed by AstraZeneca It was approved by FDA in November 2015 and CFDA in March 2017, setting a record for the fastest speed of listing of imported drugs in China after the implementation of chemical drug registration and classification in 2007 Oxitinib will become a strong competitor of exitinib in China's lung cancer market Afatinib was developed by bringer Ingelheim It was approved by FDA in July 2013, and approved by CFDA in February 2017 Its trade name is "giterry" Afatinib is the world's first listed irreversible inhibitor of the ErbB family of tyrosine kinase (TKI) receptor, which is used in the first-line treatment of metastatic non-small cell lung cancer Compared with the first generation EGFR-TKIs that has been listed in China, afatinib has obvious clinical advantages In 2017, the product entered the Chinese market with a small market share and is in the period of market introduction In the future, it will perform well in the Chinese lung cancer market The competition of ektinib intensified Ektinib was developed by Beida pharmaceutical industry It is the first small molecule targeted anticancer drug with independent intellectual property rights in China It was approved by the former CFDA to be listed in June 2011, and its trade name is "Kemena" Exetane is an inhibitor of epidermal growth factor receptor tyrosine kinase (EGFR-TKI), which is suitable for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with sensitive gene mutation of EGFR In May 2016, Beida Pharmaceutical Co., Ltd participated in the national drug price negotiation and reached an agreement to include ektinib in the first batch of medical insurance negotiation catalogue, with a substantial price reduction of more than 54%, achieving the purpose of price for quantity According to the company's 2017 financial report, after exetane was included in the national health insurance catalog, the annual sales volume was 1.026 billion yuan, with a year-on-year growth of more than 40% At present, the product has become the leader of the domestic lung cancer targeted drug market Exetane, gefitinib and erlotinib are EGFR-TKI inhibitors The patents of gefitinib and erlotinib have expired In 2017, the first domestic generic drug of Qilu pharmaceutical, gefitinib, took the lead in the market, and its price has a greater advantage than the original research products At present, at least 25 domestic companies are applying to copy gefitinib, and 6 of them have submitted listing applications This means that more generic drugs will enter the market quickly in the near future, and the competition will be more intense in the future At least 28 other companies are applying to copy erlotini, including Hengrui pharmaceutical, Luoxin pharmaceutical, Xiansheng pharmaceutical and other powerful enterprises In 2018, the competitive environment faced by the main product of Beida pharmaceutical, exetini, will be further intensified Gefitinib is developed by AstraZeneca, approved by FDA in May 2003, and approved by CFDA in December 2004 Its trade name is "Iressa" Gefitinib is the first EGFR tyrosine kinase selective inhibitor, which is suitable for the continuous treatment of platinum and docetaxel chemotherapy failure of local advanced or metastatic non-small cell lung cancer The structure patent of gefitinib in China has expired in April 2016 In December 2016, Qilu pharmaceutical gefitinib was approved for listing by the original CFDA, with the trade name of "IRICO" Global sales of AstraZeneca gefitinib have declined year after year due to patent expiration In 2017, the product was included in the national medical insurance catalog, indicating the value of gefitinib in the treatment of non-small cell lung cancer, and highly recognized by domestic experts in this field In the future, the accessibility of China's market will be greatly increased At present, gefitinib has been recommended by various guidelines, and has successfully entered the first-line drugs from the second and third-line drugs, including the ongoing joint treatment research It can be seen that with the further research, the value of gefitinib will be really excavated out, and the market position will gradually improve At present, AstraZeneca and Qilu pharmaceutical are competing in the domestic market of gefitinib Qilugifetinib is the first one to be listed on the market It has successfully broken the long-term exclusive monopoly situation of foreign pharmaceutical giants and opened the era of affordable targeted treatment of domestic non-small cell lung cancer In 2017, Qilu pharmaceutical's products have rapidly entered the market and have grown rapidly It is reported that Qilu pharmaceutical gefitinib has passed the consistency evaluation of generic drugs, and domestic high-quality products have a great potential to replace imports, which is expected to achieve accelerated growth Conclusion: in recent years, the global cancer targeted treatment has achieved great development, and Chinese pharmaceutical enterprises are also laying out targeted drugs, but there is still a big gap compared with developed countries in Europe and America In recent years, domestic enterprises are constantly catching up, which is not only reflected in the recognition of patients' market, but also in the national attention to this kind of drugs At present, a number of cancer targeted drugs have been included in China's medical insurance catalog, which shows that the policy level attaches great importance to cancer targeted drugs.