How can R & D enterprises win the second half of the year?
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Last Update: 2018-11-14
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Source: Internet
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Author: User
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Recently, another wave of good news about the progress of new drugs came to China The NDA of the investigational drug adamumumab injection biological similar drug of Cinda biology was accepted by the drug regulatory bureau, which is the second NDA of the company after the acceptance of the listing application of cindilimab On the same day, Beihai Kangcheng's first product, CommScope Gamma The news of listing in China also came one after another They are all representative and cutting-edge enterprises focusing on innovative drug research and development in China, and they are making new progress in the "spring of innovative drugs" in China In fact, since this year, a number of domestic R & D companies have successfully launched a number of therapies, such as Ge Li's hepatitis C drug gonovi, Hutchison Whampoa's furaquitinib, and zaiding's zele At the same time, zanubrutinib and tirelizumab of Baiji Shenzhou, and cindili mAb of Cinda biology have entered the pre IPO sprint stage It can be expected that these innovative drugs are bringing new treatment hope to Chinese and even global patients But at the same time, for these R & D enterprises, the commercialization of innovative drugs has begun with the launch of new products In the new era, commercialization has become the core competitiveness of innovative drug companies in the second half, and also the next key to determine that a new drug can finally reach the hands of patients and benefit them In the past few years, the improvement of regulatory environment has made the first batch of domestic innovative R & D enterprises obtain the opportunity of rapid development After several years of hard work, the first batch of independent R & D projects of innovative drug R & D enterprises in China entered the harvest period in 2018 Several products have been successfully approved for listing, many new drugs are applying for listing, and some are in the late clinical research For example, on June 8, Ge Li's first innovative hepatitis C drug, gonovi, was approved for marketing in China In October, the application for listing of another innovative hepatitis C drug, ravidavir hydrochloride (asc16), was included in the priority review process, which is expected to be launched quickly On September 5, Hutchison Whampoa announced that its independently developed target drug, fruquintinib, was approved for marketing in China for metastatic colorectal cancer This is an innovative drug that is not listed at home and abroad, and has far-reaching significance On October 22, naraparib, the first product of zaiding medicine, was approved in Hong Kong to treat platinum sensitive recurrent ovarian cancer This is a PARP inhibitor that does not need to consider whether the BRCA gene is mutated At the same time, a number of applications for listing of new drug projects have been reviewed by the drug regulatory bureau As Baiji Shenzhou said in a recent announcement, the company has three new drug listing applications (NDA) under review, including zanubrutinib in the treatment of relapsed / refractory chronic lymphocytic leukemia / small lymphocytic lymphoma patients and mantle cell lymphoma patients, and tirelizumab in the treatment of relapsed / refractory classic Hodgkin's lymphoma patients In addition, some R & D companies have obtained the rights and interests of development and commercialization in China by introducing innovative drugs or advanced therapies that have been listed in foreign countries through licensing In the current environment of encouraging innovation and accelerating review and approval in China, such products will have the opportunity to catch up Zaiding has also recently obtained the exclusive commercial license of novocure's tumor electric field therapy (TTF) in Greater China, which has been approved in the United States, Europe and Japan for the treatment of glioma ▲ Mr bill Doyle, executive chairman of novocure, introduced tumor electric field therapy at the 2018 Wuxi apptec Global Forum As a whole, this batch of Chinese innovative drugs are entering the harvest period, which means that these R & D enterprises have achieved success in the first half of the innovative drugs But it can not be ignored that for these enterprises engaged in innovative drug research and development, commercialization and marketing ability is still a new topic Dr Wu JINZI, chairman of Geli, said in an exclusive interview with Wuxi apptec recently: "at present, there are many companies engaged in new drug research and development in China, but there are only a few companies that have really completed product research and development to the stage of commercialization Most of our entrepreneurs are scientists, who are very good at R & D, but they lack a lot of experience in commercialization Therefore, for many returnees, the challenge of commercialization may be greater For golly, the approval of gonovi's launch only means that the R & D of this product is over, and the market challenge is just beginning " Embracing the new era, how can R & D enterprises win the second half? With the advent of the spring of Chinese innovative drugs and the listing of these innovative products, how to explore the layout of R & D enterprises for commercialization is gradually becoming the focus of the industry From the perspective of the commercialization progress of Geli, Geli and China Resources pharmaceutical announced comprehensive strategic cooperation in commercial distribution channels and terminal services in June this year to prepare for the listing of gonovi in advance After going on the market, gonoway first made a breakthrough in Tianjin and entered the Tianjin medical insurance pay per head pilot; later, in the Shaoxing action plan for improving the prevention and treatment of hepatitis C, it became the only small molecule direct anti hepatitis C drug with financial subsidies ▲ Geli product pipeline (photo source: Geli official website) according to Dr Wu JINZI, Geli started to build a commercial team as early as two years ago, and now has recruited 150 professionals, who basically have experience in liver disease drug sales in multinational enterprises, which has played a very important role in the rapid promotion of gonovi "We have also participated in a lot of large-scale academic conferences at home and abroad We have carried out academic exchanges with clinical experts through the release of clinical data, holding satellite meetings and other forms, which has also played a great role in the promotion of products after they are launched on the market In addition, it's the choice of business partners Now we have established very good cooperative relations with mainstream domestic pharmaceutical distributors such as China Resources pharmaceutical With their channels all over the country, now gonovi can cover most of the country and facilitate the treatment of patients nearby " Another enterprise, Baiji Shenzhou, has also arranged ahead of time First, it has obtained the exclusive commercial rights and interests of three listed cancer drugs of Xinji company in China, and started the substantial commercial operation of products Then, it has attracted Dr Wu Xiaobin, the head of China's multinational pharmaceutical companies, to help its global commercial operation According to the 2018 Q3 financial report data of Baiji Shenzhou, in the third quarter, the product revenue generated by the sales of Abraxane, Rimage and vaisar in China reached US $38.45 million, an increase of 22% compared with the previous quarter and 146% compared with the fourth quarter of 2017 Among them, widasa (azacytidine for injection) was used to treat MDS, AML with 20% - 30% myeloblastic cells and CMML ▲ Baiji Shenzhou product pipeline (photo source: Baiji Shenzhou official website) at present, there are three new drug listing applications in Baiji Shenzhou under review, which are expected to be listed quickly "Our team has made significant progress in pushing these promising cancer therapies to potential commercialization," Mr Ou Lei Qiang, founder, CEO and chairman of Baiji Shenzhou, said in the announcement With the listing of zele in Hong Kong, the commercial layout of zaiding pharmaceutical is also in full swing Liang Yi, who joined zengding pharmaceutical this year and served as the chief business officer, recently mentioned in an interview that it is his important job to form a business team Before that, Liang Yi was engaged in the commercialization layout of innovative drugs in China in multinational pharmaceutical enterprises ▲ zaiding pharmaceutical product pipeline (photo source: zaiding pharmaceutical official website) in addition, some well-known venture capital institutions also expressed some forward-looking views For example, Dr Chen Lianyong, founder partner and chief executive officer of Tong and Yucheng, said in an exclusive interview with Wuxi apptec that in the future, there will be some new modes of investment in China's pharmaceutical industry In addition to focusing on innovation, merger and acquisition will also be considered Because there are some domestic companies that lack innovative R & D capabilities, but have perfect sales system, if they can put marketing capabilities and innovative drugs together through M & A and other ways, it will be a useful thing.
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