[Hui Cong Pharmaceutical Industry Network] This year, a number of major imported new drugs have been approved, and the products in the field of cancer have received much attention in the industry. Peazapani's global sales soared, and afatinib joined the fight for lung cancer targeted drugs. Ochinib will shuffle the NSCLC market, and the global market for vemolinia fell slightly. The following is a summary of the market conditions for these drugs.

(A brief analysis of the newly approved anti-tumor drug market pattern)

With the speed of drug review and approval, a number of major imported new drugs have been introduced this year. Among them, the main imported tumor products are: Pesapini tablets of Glaxoin, Alfinib tablets of Boehringer Ingelheim, Remifenib tablets of Roche, Ochinib tablets of AstraZeneca, Rigo of Bayer Non-negative tablets; hepatitis C products include: Darstalvir tablets and ashuruwei soft capsules of Bristol-Myers Squibb; Diabetes products include: dapagliflozin, saxagliptin metformin sustained-release tablets; anti-rheumatic products have Pfizer Tofatti tablets and so on.

The large number of imported new drugs approved will cause the market pattern of tumors, hepatitis C, diabetes and high blood pressure to change quietly. The following is mainly to sort out the recently approved imported tumor products.

Peazapani's global sales soared

Pazopanib was developed by GlaxoSmithKline and was approved by the FDA on October 19, 2009 under the trade name "Votrient". This product is mainly suitable for the treatment of advanced renal cell carcinoma and soft tissue sarcoma. Votrient is an oral drug that interferes with the formation of new blood vessels needed for solid tumor growth and survival.

According to statistics of global best-selling drugs, Pezza Pani has sales of 155 million US dollars in 2011, sales of 565 million US dollars in 2015, and sales of 729 million US dollars in 2016, an increase of 29.0% over the same period. From the sales situation in 2011-2016, the product maintained a rapid growth rate.

According to the data from the Drug Evaluation Center, GlaxoSmithKline's Pezza Pani and tablets were approved by the CFDA on February 21, 2017. The trade name is “Victor”, which is mainly used for the first stage of advanced kidney cancer (aRCC). For treatment, the dosage form is a tablet, and the specifications are 200 mg and 400 mg. At present, there are 6 companies that are currently applying for Pezza Pani tablets, namely Qilu Pharmaceutical, Jiangsu Haosen Pharmaceutical, Zhengda Tianqing Pharmaceutical, Jiangsu Osei Kang Pharmaceutical, and Yangzijiang Pharmaceutical.

Afatinib joins the fight for lung cancer targeted drugs

Afatinib was developed by Boehringer Ingelheim, Germany, as a new generation of oral small molecule tyrosine kinase inhibitors. The product was first approved by the FDA on July 12, 2013 under the trade name "Gilotrif" for the treatment of patients with mutant non-small cell lung cancer and HER2-positive advanced breast cancer, and on September 25, 2013. The day was approved by the European Commission (EC). At present, the United States and Europe have accepted the registration application of afatinib for the treatment of patients with advanced lung squamous cell carcinoma after first-line chemotherapy, and have passed the FDA orphan drug certification, which is intended to confer a unique status for the treatment of rare disease products.

The product is currently approved for marketing in more than 70 countries and is the fourth EGFR inhibitor approved by FDA after gefitinib, erlotinib, and lapatinib. According to global best-selling drug statistics, sales of afatinib in 2014 were $115 million, with sales of $231 million in 2015 and sales of $271 million in 2016. From the sales situation in 2014-2016, the product maintained a relatively fast growth rate. The market performed well after the market for afatinib, and global sales in 2015 exceeded lapatinib.

According to the data of the drug review center, Boehringer Ingelheim's afatinib and tablets were approved by the CFDA on February 21, 2017, and the trade name was “Jitari”. The product was approved in the country for two indications: first-line treatment for patients with epidermal growth factor receptor (EGFR) mutation-positive lung cancer, and second-line treatment for patients with lung squamous cell carcinoma. The dosage form is a tablet, and the specifications are 230 mg, 40 mg, and 50 mg. At present, there are 16 companies that are applying for afatinib tablets in China, namely, Sinopharm Group, Jiangsu Haosen Pharmaceutical, Jiangxi Qingfeng Pharmaceutical, Qilu Pharmaceutical, Yangzijiang Pharmaceutical, Jiangsu Osei Kang Pharmaceutical, Shandong New Times Pharmaceutical, Ruiyang Pharmaceutical, Zhengda Tianqing Pharmaceutical, etc.

The battle for lung cancer targeted drugs in China has already begun. In recent years, gefitinib has been reduced in price. Ecetinib and gefitinib have been included in the medical insurance drug list for the first time. More and more lung cancer targeted drugs have quickly entered the Chinese market. Prices have gradually returned to rationality.

Ochinib will shuffle the NSCLC market

Developed by AstraZeneca, Osimertinib was marketed by the FDA on November 13, 2015 under the trade name "Tagrisso" for metastatic non-small cell lung cancer with positive EGRR-T790M mutation ( The third generation of targeted drugs for NSCLC). According to global best-selling drug statistics, Ochinidan's sales in 2015 were $19 million, and sales in 2016 were $423 million. Ochinib has been approved for listing in the United States, the European Union, Japan, Israel and South Korea, and six countries and regions in Bangladesh. It has shown strong momentum in the first year of listing. According to professional forecasts, the peak annual sales of Ochinib are expected to reach $3 billion. According to the data from the Drug Search Center, AstraZeneca Oxitinib and tablets were approved by the CFDA on March 22, 2017 under the trade name “Terisha”, mainly for T790M mutations in EGFR of non-small cell lung cancer. The product. The dosage form is a tablet, and the specifications are 40 mg and 80 mg. This product is China's first third-generation lung cancer targeted drug.

According to statistics, about 85% of the 730,000 new lung cancer patients in China each year are non-small cell lung cancer, and nearly 50% of them have EGFRT and 790M mutations. Lung cancer is China's largest cancer, with huge clinical needs, using first- and second-generation targeted drugs such as gefitinib (Iressa), erlotinib (Troquet), ectinib (Kami Oxitinib can be used in patients who develop T790M mutations after drug resistance such as afatinib (Gitari). In the next few years, the confrontation of these products will be inevitable.

According to public information, in September 2016, Ochinib was included in the rapid review channel by CFDA, and was approved 7 months later. Compared with the US approval in November 2015, the time to market in China is only 1 year and 4 months apart. . The NSCLC market is changing, and the listing of Ochitinib will usher in the reshuffle of the NSCLC market.

Virmofenni's global market slightly lower

Developed by Roche, Vemurafenib was approved by the FDA in August 2011. The trade name is “Zelboraf”, which is mainly used to treat melanoma. It is the second treatment for melanin after Yervoy is approved by the United States. Tumor drugs. The product has been approved in 99 countries and regions including the United States and the European Union. The treatment of melanoma in Roche's global innovative drug pipeline is also the MEK inhibitor Cobimetinib and the PD-L1 monoclonal antibody Atezolizumab, a different innovative combination of three drugs for different types of melanoma. According to global best-selling drug statistics, sales of vemurafen in 2015 were US$218 million, and sales in 2016 were US$213 million, down 2.2% from the same period. From the sales situation in 2015-2016, the market for this product has declined. In the past two years, the main reason for the decline in sales of vemurafen was due to the competition of PD-1 antibody Bristol-Myers Squibb's Opdivo and Merck's Keytruda. In 2016, Opdivo and Keytruda achieved sales of $3.77 billion and $1.402 billion, respectively.

According to the data of the drug review center, Shanghai Roche Pharmaceuticals Co., Ltd. and pheromones have been approved by the CFDA on March 10, 2017. The product name is “Zabobo”, which is mainly used to treat CFDA-approved test methods. BRAFV600 mutation-positive inoperable resection or metastatic melanoma. Vermofinil is the first high-selective BRAF inhibitor approved in the market in China. The dosage form is tablet and the specification is 240mg. At present, domestic companies have not yet been notified of the registration of vemurafen tablets to CFDA.

Editor in charge: Ding Qiushi