In three days, three local pharmaceutical companies have been approved to be listed and innovated?

Source: within three days from December 5, 2017, the heavy new drugs of three local enterprises were approved one after another For a group of local enterprises including Kelun, Shuanglu and hausen, this is undoubtedly an important return for their early innovation layout On the other hand, with the approval of more and more local heavyweight new drugs, the situation of import substitution in the field of high-end products will continue to intensify On November 30, Kelun pharmaceutical announced that it had recently obtained the new drug certificate and drug registration approval document of raw materials and preparations of chemical drug "parecoxib sodium for injection" approved and issued by CFDA Parecoxib sodium for injection is the only selective cyclooxygenase-2 (COX-2) inhibitor available for injection in the world It is mainly used for the treatment of postoperative pain and is one of the basic drugs for clinical multimodal analgesia Two days later, lenalidomide, a heavyweight product of Shuanglu pharmaceutical, received the new drug certificate and drug registration approval issued by CFDA With the approval of this star product, which has attracted the attention of the industry, the competition in the domestic multiple myeloma market is imminent On the same day, the drug approval document of Xintai (bortezomib for injection), a new anti-tumor drug of hausen pharmaceutical, was sent to Jiangsu food and drug administration It is reported that this heavyweight variety has officially obtained the production approval document issued by CFDA for the treatment of multiple myeloma and mantle cell lymphoma, which also means that bortezomib, a heavyweight anti-tumor drug, has been localized Within three days, three local enterprises have been approved of the heavyweight new drugs For a group of local enterprises, including Cohen, Shuanglu and hausen, this is undoubtedly an important return for their early innovation layout On the other hand, with the approval of more and more local heavyweight new drugs, the situation of import substitution in the field of high-end products will continue to intensify 1 With the approval of the application for raw materials and injections of parecoxib sodium, the company has become the first enterprise in China to obtain production approval Up to now, collen has invested about 14.1 million yuan in the research and development projects of parecoxib sodium and parecoxib sodium for injection Parixib sodium for injection was originally developed jointly by Pfizer and famasia It was first launched in Europe in 2002, with the trade name of dynastat and specifications of 20mg and 40mg At present, it has been listed in at least 15 countries such as Germany, France and the United Kingdom In 2008, parecoxib sodium for injection was approved to be listed in China, with the trade name of TERT, which is a class B product of national medical insurance In 2016, the sales volume of TNT in China was about 765 million yuan According to e drug managers, before the product was launched, Cohen had set up a strong prescription drug marketing team, which has been developing From its 2016 annual report, the fastest growing is the sales of prescription drugs It can be seen that it is not a strong company in the sales of large-scale infusion, but also built the sales capacity of prescription drugs With the launch of the product, Cullen will inevitably attack Pfizer Liu Sichuan, general manager of Kelun, once said that as long as Kelun has a new drug product on the market, it is confident to make it bigger quickly According to CICC, it is expected to become a heavyweight product with a peak value of 500-1 billion yuan At present, Pfizer's Prix price is between 111 yuan and 133 yuan With the price advantage, Cologne can occupy 30% of the original research market share in the future In the long run, parecoxib sodium is expected to compete for the market space of some opioid analgesics represented by dizosin Currently, dizosin is widely used in general anesthesia induction, postoperative analgesia and preemptive analgesia, with a national sales volume of more than 5 billion yuan in 2016 As an inhibitor of COX-2, the combination of parecoxib and opioids can significantly reduce the dosage of opioids and related adverse reactions In addition to parixib sodium, coven, another gastrointestinal nutrition product, is also expected to be approved within this year If approved, coven will become the first imitator of the product and continue to increase the company's performance In 2016, Liu Chuangxin, chairman of Kelun pharmaceutical, said in an interview with e pharmaceutical manager that the company has entered the first array of Chinese pharmaceutical innovation No matter the product line layout, product value under research, or the R & D team, Kelun is undoubtedly the first camp in China Five years later, "I won't say that because I'm number one." In the past three years, Kelun's R & D investment has reached 1.3 billion yuan, 347 R & D projects have been arranged, covering more than 10 major diseases such as cancer, liver disease and diabetes, and 100 projects have been declared, 30 of which are the first in China Since the beginning of this year, Kelun has entered the R & D return period, and 10 new varieties have been declared or entered the clinical stage For Kelun, first imitation and early imitation are to meet the clinical needs of China and strive for market leading position; small molecule innovative drugs are the core competitiveness of enterprises in the future, and me too can break through the original research patent barriers and realize the early listing of products, while me better and first in class have the opportunity to participate in global competition; while Biotechnology In recent years, surgical drugs have become a hot area of global research and development Although Cohen has been involved a little later, it can directly apply the next generation technology and make breakthrough progress Although the new drug delivery system (NDDs) mostly belongs to the category of imitation, it is difficult to follow the imitation of high-tech internal products such as liposomes, microspheres, nanoparticles, etc once owned, it will have a sitting high-end market capital 2 after Shuanglu challenged Xinji 7.31 clinical self examination storm, four lenalidomine acceptance numbers of Shuanglu pharmaceutical and its related enterprises were once transferred back for review, but less than a year later, the priority review of lenalidomine of Shuanglu turned the event The attention of the outside world to this drug is not only because of the ten-year development of Shuanglu, but also because of the patent barrier built by lenalidomide, the most important product of the new base Obviously, Shuanglu has broken through the restrictions and realized the localization of lenalidomide In 2005, the FDA approved lenalidomide, which was developed and produced by new base, with the trade name of Revlimid, for the treatment of myelodysplastic syndrome Later, it was successively approved by the FDA for the treatment of multiple myeloma and mantle cell lymphoma In 2016, Revlimid contributed $6.974 billion in sales to Xinji, and the sales in the first three quarters of this year has reached $5.999 billion With the continuous expansion of indications, fiercepharma once predicted that its sales volume in 2022 would be US $13.44 billion, becoming the best-selling cancer drug in that year In fact, it wasn't until 2013 that the new group lenalidomide officially entered the Chinese market, under the trade name of rimex At present, there are two indications of rifamycin approved in China, multiple myeloma and myelodysplastic syndrome The patent expires in 2024 Recently, Xinji and Baiji Shenzhou reached a strategic cooperation In addition to product authorization, according to the cooperation agreement, Baiji Shenzhou also took over Xinji's business team in China, and assumed its approved products in China: Abraxane for the treatment of advanced breast cancer, remipamil for the treatment of multiple myeloma and lenalidomide for the treatment of myelodysplastic syndrome The sales function of vaisar and the commercial responsibility of cc-122 The biggest reason why Xinji transferred its Chinese business to Baiji Shenzhou is that its marketing ability is weak, and the Chinese market performance has been difficult to match with its global market ability But now it has transferred to Baiji Shenzhou, a company with no sales experience, which still cannot achieve better sales Therefore, in November, Baiji signed the three products with China Resources Guokang (Beijing) Pharmaceutical Co., Ltd We hope that the channel advantages of China resources can help the bidding and drug admission From the domestic sales situation of new base products, it is at the same level as Shuanglu, so the market competition is just beginning It is worth noting that the products of Xinji belong to re construction sales, but Shuanglu has its own sales and channels On the whole, in terms of marketing ability, Shuanglu is slightly better than others, and it is likely to use the price advantage to fight against it, so as to realize import substitution However, the biggest moat of Xinji is medical insurance After the first drug price negotiation out of the Bureau, this year's new base Rimage finally entered the medical insurance catalog through negotiation The prices of 10mg and 25mg dropped to 866 yuan and 1101.99 yuan respectively The price of 1 mg / bottle and 3.5 mg / bottle also dropped to 2344.26 and 6116 yuan respectively Both drugs limit the scope of medical insurance payment and need to meet certain conditions In addition to transnational competitive products, local enterprises are also in this field According to the data, 11 domestic companies have developed the drug and obtained the approval of clinical trials, including Qilu pharmaceutical, hausen pharmaceutical, Zhengda Tianqing, etc Among them, Zhengda Tianqing's application for listing has been accepted by CDE, while bortezomib for injection of hausen and Shuanglu were approved on the same day, and the battle between domestic and import is on the verge In 2003, the FDA approved bortezomib for the treatment of relapsed and refractory multiple myeloma In September 2005, bortezomib entered the domestic market Xi'an Janssen occupies the main market share of bortezomib in China According to the company's financial report, in 2016, bortezomib's sales in the mainland China reached nearly 800 million yuan, becoming the largest product of Xi'an Janssen The expiration of bortezomib's patent opened opportunities for domestic enterprises, and the first imitation competition was launched, including 19 enterprises including Qilu, Zhengda Tianqing and Haizheng From the current progress, it is clear that hausen has been ahead Bortezomib from YANGSEN, Xi'an, has entered the medical insurance catalogue through this year's drug price negotiation As the Chinese patent protection of bortezomib has expired, the degree of competition is self-evident Therefore, it is the choice of multinational pharmaceutical companies to exchange price for quantity On the other hand, in China's multiple myeloma market, which is increasingly hot, in addition to the same kind of competition of bortezomib, it also faces the threat of lenalidomide According to data statistics, at present, the main therapeutic drugs for multiple myeloma in the Chinese market are Janssen's Vanke (bortezomib) and Xinji's rifeme In 2016, the sales volume of bortezomib in mainland China was close to 800 million yuan, which was the largest product of Xi'an Janssen; in the same year, the sales volume of naduramine was about 200 million yuan, and the scale of bortezomib was about four times of that of lenadamine, which was quite different from the international market Although it is not as large as bortezomib in terms of drug use scale, lenalidomide is growing rapidly in terms of growth rate In 2014, it increased by 13.4 times, and in 2015 and 2016, it increased by 143% and 88%, respectively In contrast, the growth rate of bortezomib was about 13%.