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Zhengda Tianqing Erlotinib was approved by the lung cancer targeted drug market who is strong?
Recently, the State Drug Administration approved the introduction of a small molecule multi-target receptor tyrosine kinase inhibitor, erlotinib hydrochloride (Focco), for the treatment of advanced or metastatic non- Small Cell Lung Cancer. The penolidine hydrochloride capsule belongs to the innovative drug independently researched and developed by China, and is approved for listing through the priority review and approval process.
Priority review of the listing sprint
From April 2017, Chia Tai Tsing submitted the production application of erlotinib hydrochloride capsule to its approval, which took one year and was widely concerned by the industry.
Of course, this is not the first product to benefit from the priority review channel. Merck's nine-valent HPV vaccine took only eight days from application to approval, and its priority review process progressed rapidly, setting a new record.
On April 20, the Merck 9-purchase HPV vaccine submitted a new drug application. Three days later, the CDE was included in the 28th batch of priority review catalogue, and the 28th CDE approved the conditional listing. The next month, the first nine-priced HPV vaccine supplement purchase will land in Hainan. May 10, Hainan Province issued a notice of public resources trading center, the Hainan provincial CDC to supplement finalists procurement, and asked its manufacturer Merck dealer Zhi Fei biological negotiate the price the next day. On May 11, the price negotiation results were released. The nine-priced HPV vaccine (two packages) is 1298 yuan each.
Obviously, the achievements brought about by the implementation of the priority review system have gradually emerged. The "Opinions on Resolving the Approval of Priority Examination and Approval of Drug Registration Applications" issued at the beginning of 2016 marked the official landing of the 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 Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices ," again mentioning the need to speed up the review and approval.
In the past two years, as of the deadline for publication, CDE has published a total of 28 batches of applications for drug registration in the priority review process. Allotinib hydrochloride capsules and 9-valent HPV vaccines are among them. The reason for the priority review of the 9-valent HPV vaccine is that it has obvious clinical advantages, and the penolidine hydrochloride capsule also has obvious therapeutic advantages compared with the existing treatment methods.
Look at the domestic and international lung cancer market
In the past few years, significant progress has been made in the treatment of lung cancer worldwide, and new targeted therapies continue to emerge, bringing dramatic advances in the treatment of lung cancer. Multinational pharmaceutical giants have long been ignoring China's huge lung cancer treatment market. In the face of the impact of foreign heavy drugs, domestic companies should think about how to deal with them in order to quickly enter the market and seize the high-end market share of lung cancer.
According to the 2018 US cancer statistics, lung cancer is the second most common cancer in malignant tumors and the leading cause of death. It is a major killer of human life and health. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of lung cancer patients. According to the World Health Organization, there are 1.8 million new lung cancer patients each year and the death toll is 1.6 million.
International market PD-1 antibody boost
According to statistics of global best-selling drugs, in 2017, the sales of 7 monoclonal antibodies in foreign countries were: Roche's bevacizumab 7.141 billion US dollars, Bristol-Myers Squibb's Nawu monoclonal antibody 5.767 billion US dollars, Merck Pim's monoclonal antibody of 3.809 billion US dollars, Bristol-Myers Squibb's Ipilimumab 1.244 billion US dollars, Eli Lilly Rembrandt's 758 million US dollars, Roche's Tecentriq sales of 477 million US dollars, AstraZeneca's Imfinzi sales $19 million. The total sales of the above seven products totaled US$19.2 billion, of which the two products that grew faster were: Optivo (Navuximab) from Bristol-Myers Squibb and Keytruda (Pemm) at Merck.
The sales of tetanic drugs that have been listed abroad are: AstraZeneca's Oxitianib 955 million US dollars, Roche's erlotinib 893 million US dollars, Pfizer's crizotinib 595 million US dollars, AstraZeneca's Jifei Tiny's 527 million US dollars, Roche's erlotinib 362 million US dollars. The product with the fastest growth of the above products is AstraZeneca's Tagrisso (Ohitini).
In 2017, global lung cancer targeted drug sales reached nearly $24 billion. Merck's PD-1 antibody Keytrud has obtained a PD-L1 >50% first-line lung cancer label as a single party, which covers approximately 25% of patients. In April 2018, Merck announced that Keytruda had a phase III clinical meta-analysis that showed a significant improvement in PD-L1>1% survival compared with platinum-based chemotherapy. This population increased the number of Keytruda first-line users to 70% if they entered the label. Will further consolidate Merck's Keytruda's dominance in the most important market for lung cancer.
New products in the domestic market perform well
According to the statistics of domestic sample hospitals, in 2017, the sales of bevacizumab, a listed monoclonal antibody in China, was 570 million yuan, an increase of 30.90% over the same period. The product has maintained rapid growth since its listing.
There are 6 domestically available fentanyl drugs in the sample, the amount of drug used in the sample hospital: sales of gefitinib in AstraZeneca and Qilu are 419 million yuan; sales of edetinib in idada are 298 million yuan; sales of freibizotinib The amount of 98.16 million yuan; Roche erlotinib sales of 96.43 million yuan; AstraZeneca Oxitinib sales of 9.18 million yuan; Boehringer Ingelheim afatinib sales of 160,000 yuan.
In 2017, foreign lung cancer heavy drugs successively landed in the domestic market, namely AstraZeneca's Ochinib and Boehringer Ingelheim's Alfatinib. In the future, oxitinib and afatinib will be potential heavy drugs in the lung cancer targeted drug market in China.
Oxitinib was developed by AstraZeneca and approved by the FDA in November 2015. It was approved by the original CFDA in March 2017, setting a record for the fastest speed of imported drugs in China after the registration of chemical drugs in 2007. Ochinib will become a strong competitor to Ekterini in the Chinese lung cancer market.
Afatinib was developed by Boehringer Ingelheim and was approved by the FDA in July 2013. It was approved by the original CFDA in February 2017 and is marketed under the trade name “Jitariâ€. Afatinib is the world's first irreversible inhibitor of the ErbB family of tyrosine kinase (TKI) receptors for the first-line treatment of metastatic non-small cell lung cancer, compared with the first-generation EGFR-TKIs currently available in China. It has obvious clinical advantages. In 2017, the new product entered the Chinese market with a small market share and is in the market introduction period. In the future, the Chinese lung cancer market will have a good performance.
Incremental competition for ectinib
Ektinib was developed by Beida Pharmaceutical Co., Ltd. It is the first small molecule targeted anticancer drug with independent intellectual property rights in China. It was approved by the original CFDA in June 2011 and its trade name is “Kemenaâ€. Ectininib is an epidermal growth factor receptor tyrosine kinase (EGFR-TKI) inhibitor for the first line of locally advanced or metastatic non-small cell lung cancer with sensitive gene mutations in the epidermal growth factor receptor (EGFR). treatment.
In May 2016, Beida Pharmaceutical participated in the national drug price negotiations and reached an agreement to include Ekentini in the first batch of medical insurance negotiation catalogues, significantly reducing the price by more than 54%, and achieving the purpose of price conversion. According to the company's 2017 financial report, after being included in the national medical insurance catalogue, ectinib's annual sales amounted to 1.026 billion yuan, and sales increased by more than 40% year-on-year. Currently, the product has become the leader in the domestic lung cancer targeted drug market.
Ecetinib, gefitinib and erlotinib are both EGFR-TKI inhibitors, and gefitinib and erlotinib have expired. In 2017, Qilu Pharmaceutical's first domestic drug, gefitinib, was first introduced, and its price has a greater advantage than the original research product.
At present, at least 25 companies in China are applying for imitation of gefitinib, and 6 of them have submitted listing applications. This means that more generic drugs will enter the market soon, and the competition will become more intense in the future. At least 28 companies are applying for imitation of erlotinib, including strong companies such as Hengrui Medicine , Luoxin Pharmaceutical, and Xiansheng Pharmaceutical. In 2018, the competitive environment faced by Beida Pharmaceutical's flagship product, Ektini, will further intensify.
Gefitinib
Gefitinib was developed by AstraZeneca, approved by the FDA in May 2003, and approved by the original CFDA in December 2004 under the trade name “Iressaâ€. Gefitinib is the first epidermal growth factor receptor (EGFR) tyrosine kinase selective inhibitor for single-agent continuous treatment of platinum and docetaxel chemotherapy failure in locally advanced or metastatic non-small cell lung cancer.
The structural patent of gefitinib in China expired in April 2016. In December 2016, Qilu Pharmaceutical gefitinib was approved by the original CFDA, and the trade name was “Irecoâ€. Due to the expiration of the patent, AstraZenefi gefitini has seen its global sales decline year after year. In 2017, the product has been included in the national medical insurance catalogue, indicating the value of gefitinib in the treatment of non-small cell lung cancer, and has been highly recognized by experts in the field in China, and the accessibility of the Chinese market will increase greatly in the future.
At present, gefitinib has been recommended by major guidelines, and the second- and third-line drugs have successfully entered the first-line drugs, including ongoing joint treatment research. It can be seen that with the further study, the value of gefitinib is truly excavated and the market position will gradually increase.
At present, in the domestic gefitini market, AstraZeneca and Qilu Pharmaceutical compete on the same stage. The first listing of Qiluji Fetini, successfully broke the long-term exclusive monopoly of foreign pharmaceutical giants, and opened the era of low-cost targeted therapy for non-small cell lung cancer in China. In 2017, Qilu Pharmaceutical's products have quickly entered the market and are growing rapidly. It is reported that Qilu Pharmaceutical gefitinib has passed the evaluation of generic drug consistency, and domestic high-quality products have a large space to replace imports, which is expected to achieve accelerated growth.
Conclusion>>>
In recent years, global cancer targeted therapy has achieved great development. Chinese pharmaceutical companies are also deploying targeted drugs, but there is still a big gap compared with developed countries in Europe and America. In recent years, domestic enterprises have been constantly catching up. This is not only reflected in the patient market recognition level, but also in the country's attention to this class of drugs. At present, several cancer-targeted drugs have been included in China's medical insurance catalogue, showing The policy layer is facing the importance of cancer-targeted drugs.