Rolapitant, a patent antiemetic drug introduced by Hengrui tesaro for tumor adjuvant treatment

On July 30, 2015, Hengrui issued a notice: Jiangsu Hengrui Pharmaceutical Co., Ltd reached an agreement with American tesaro company to introduce rolapitant, a patent antiemetic drug of tesaro (NASDAQ: TSRO) Company for tumor adjuvant treatment Hengrui will be authorized to be responsible for the clinical development, registration, production and sales of the drug in China Rolapitant, developed by tesaro company, is an NK-1 receptor antagonist There are two dosage forms of rolapitant At present, oral dosage forms have completed phase III clinical trials in the United States, and they are in the phase of FDA approval and listing in the United States Currently, phase I clinical trials are being carried out in the United States Tesaro company was founded in 2010 and listed on NASDAQ in the United States It focuses on the R & D, production and sales of tumor therapy and its auxiliary drugs The R & D pipeline involves small molecule targeted therapy drugs, monoclonal antibodies and antiemetics This is also a rare large-scale introduction of cooperation projects by Hengrui in recent years The opening of this transaction also means that Hengrui's huge book capital will be invested in M & A and cooperation projects, and it will go out to sea and buy and sell projects abroad at the same time With the increase of cancer patients, chemotherapy-induced nausea and vomiting (CINV) is also a huge market It is estimated that the U.S post chemotherapy nausea and vomiting drug market is more than $2 billion, mainly NK-1 receptor antagonists and 5-HT3 receptor antagonists At present, CINV drugs in the market mainly include ondansetron, granisetron, dorasetron, palonosetron and aripitan It was found that NK-1 receptor was highly expressed in brain and other tissues of the body Activation of NK-1 receptor leads to the release of neurotransmitters and other signaling molecules, which can play a central role in controlling nausea and vomiting In 2003, arepidem was the first neurokinin-1 (NK-1) receptor approved for marketing in the world, i.e substance P antagonist; on January 25, 2008, fosapitam dimethylmeglumine injection was approved for marketing under the trade name emend, which is the same as that of arepidem Fosapitam is the prodrug of aripitan, which is injected into the body and becomes aripitan In 2014, aripitan capsule was approved by China CFDA for marketing Research shows that more than 75% of chemotherapy drugs can lead to nausea, vomiting, metabolic disorders, malnutrition and even refusal of further chemotherapy, which affect the quality of life and anti-tumor treatment effect of patients The prevention and treatment of such adverse reactions are very important, as are chemotherapy regimens Nearly 7 million chemotherapy patients in the United States need to prevent and treat chemotherapy-induced nausea and vomiting (CINV) According to the current treatment guidelines, 70% to 80% of cancer patients need to use NK-1 receptor antagonists Emerd is the only NK-1 receptor antagonist product in the market, with global sales revenue of $419 million in 2011 Search "aripitan" many domestic generic drugs, what's the good about rolapitant introduced by Hengrui? Single dose, rapid effect, the effect can last for 5 days (usually the effect of the preparation can only last for 1-2 days) The clinical phase III of lorapidem in the United States has been completed, and it is in the stage of waiting for FDA's approval of production and marketing The date of PDUFA (prescription drug payment act) in FDA is September 5, 2015 According to tesaro's disclosure in the second financial report, the company is ready for rolapitant to go public in the United States in the fourth quarter of this year It can be seen that Hengrui has introduced a feasible project: the target has been verified, the clinical trial has been completed, the R & D risk has been released, and no additional R & D investment is needed The next thing to do is to quickly promote the registration and declaration, put into production and market sales as soon as possible in China with Hengrui's own clinical and declaration advantages Rolapitant in the floating bottle in March 2009, Merck & Co acquired Schering enough Corp for us $41.1 billion in cash plus shares At that time, emend (arepitan) was already in the pharmaceutical pipeline of MSD, and the product lines of the two companies were integrated In order to avoid competition of the same variety, the Federal Trade Commission of the United States requested to divest some assets In October 2009, Schering plough sold rolapitant to opko health At that time, Schering plough had completed phase II clinical trials for more than 1000 people In 2010, opko continuously sold rolapitant's product development and commercialization rights to tesaro Opko received a down payment of $6 million from tesaro and a total mileage of $121 million At the same time, opko will get a commission from the profits of future products listed in Japan and Latin America After taking over rolapitant, tesaro completed the phase III clinical trial and submitted the listing application FDA will make a decision on whether to approve or not on September 5, 2015 What Hengrui bought from tesaro is rolapitant's rights and interests in clinical development, production and marketing in China Neither party disclosed the financial details of this transaction On August 25, 2015, Hengrui will issue the China Daily I wonder if it will disclose the details of the transaction at that time I guess the amount of the transaction is not low Like Hengrui, it is the dream of many pharmaceutical companies and investors to introduce such projects that are put into production immediately The timing is right The details behind the transaction must be very interesting It's not hard to see that the focus of the transaction is still around the main line of tumor drugs, to create adjuvant chemotherapy, and to treat chemotherapy side-effect drugs, all of which are to create a moat and form a product cluster advantage The purpose of M & A is to serve the product pipeline, not only for the purpose of making good financial statements, but also for the purpose of M & A At the same time, Hengrui has outstanding R & D capabilities and complete pipeline reserves Almost popular products have created their own patent and R & D plan plan plan B when discussing in the industry, they will joke that they don't know how to buy their BD products, because there are few news about Hengrui's purchase In recent months, Hengrui has made frequent efforts In addition to this transnational purchase project, Hengrui just announced to invest RMB 850 million to establish a wholly-owned subsidiary shengdia biology in Suzhou to build a flagship of bio medicine This move will undoubtedly create a new Hengrui in the new era of bio medicine In a public speech at the end of July, I saw that Hengrui R & D pipeline: the development mode of biological drugs and small molecules, three main lines of anti-tumor drugs, diabetes / cardiovascular products, and blood / pain / anti-inflammatory products (speaking of this, if only the product pipelines of domestic pharmaceutical companies could be displayed on the official website one day and keep up with the new progress ）I see that Hengrui has 4 ADCs (antibody coupled drugs), PD-1 and PD-L1 are complete, and there may be future cell therapy products There are only two ADC drugs on the market: adcetris from Seattle genetics company and kadcyla from Roche This kind of drug is limited by the factors such as target selection and current connection technology, so I am cautious about the current ADC products, and the earlier Roche ADC platform is said to have been shut down In terms of cardiovascular, we see that the relaxin of Hengrui has reported the clinical trial application of biological drugs Among the same varieties, Novartis has a serelaxin, which is a recombinant form of human relaxin-2, but its application has been rejected by FDA at present Novartis is still in the process of testing and seeking FDA approval again There is no breakthrough drug in acute heart failure for more than 20 years In addition, PCSK9, a cholesterol lowering monoclonal antibody with high fever, is also listed on Hengrui's product line In terms of diabetes, repagliptin and henggliptin are in clinical research, and degu insulin is in clinical application The product line of the combination of imitation and creation can be called low-key and luxurious if it is disclosed and not disclosed Is the new mechanism of the first in class strategy suitable for new drug development in China? Everyone has their own answer I would like to provide a perspective and view here: the new pioneering drugs rely on breakthroughs in basic research, driven by the integration and development of new mechanisms and technologies, which need accumulation and precipitation Although there will be occasional successful examples in niche market, the risks of the new innovative drugs far outweigh the benefits for most Chinese pharmaceutical enterprises Therefore, in the next 5-10 years, it will still be the combination of imitation and innovation, and follow the innovation / micro innovation model to win At the same time, people's living standards and quality are improving, but the current medical insurance and payment conditions determine that most people want to get cost-effective drugs for treatment when they are ill Good quality generic drugs and inexpensive small and minimally invasive new drugs will be the mainstream of market demand Innovation is on the left, imitation is on the right Whether we go left or right, we hope to meet the future we want In the summer of 2015, it was destined to be recorded in the history of medicine The ice storm from the top to the bottom blew several times, which I can't remember clearly All kinds of interpretations and responses are still going on Peers laugh and cry while stunned, sometimes clap their hands and sometimes beat their chests and feet I read all the heavy news carefully, but I still can't remember too many interpretations I don't know how to evaluate these upheavals when we look back at 2015 At the end, we still write the following story: as long as there are still interests flowing in the pharmaceutical market, transactions and M & A will continue; as long as the needs of patients are not satisfied, we will have the significance of medicine making I hope you and I don't forget the beginning and the way when we came Statement: This is a personal point of view, does not constitute any investment advice and forecast, investment risk, you carefully screen:) Thank you ~ for reference: 1 Http://investor.opko.com/releasedetail.cfm? Releaseid = 415380 2 Http://ir.testarobio.com/secfiling.cfm? Filingid = 1047469-12-3207 & CIK = 1491576