Kelun pharmaceutical gambles on the development of new hepatitis C drugs

However, the patent period of the drug in the United States is more than 20 years, and the patent authorized in China expires in 2024 In this "monopoly pricing period, the possibility of generic drugs is very small" That is to say, after the third phase of clinical application, Cologne pharmaceutical industry has to solve the patent problem of suofibuvir before it can be sold on the market Colen pharmaceutical replied that there are still disputes over the approved patents of sofibove in China While focusing on the disputes, it will also focus on the development of new technologies related to sofibove and prepare to develop products with independent intellectual property rights In addition, sofibove is a part of the layout of its research institute's "long, medium and short term product line" Under the background of Kelun pharmaceutical's strong investment in scientific research and innovation in recent years, since 2013, the research institute has completed the application of 68 varieties, and a large number of the first new drug R & D reserves may promote the company to seize the historic opportunities of China's generic drugs In 2011, Geely acquired pharmaset to obtain a "big egg" coveted by numerous pharmaceutical companies, sovaldi, which is the first drug that can be used in the full oral treatment of hepatitis C Before the advent of sofibvir, patients with hepatitis C must be treated for at least six months, including interferon and ribavirin injection, which can cause serious flu like symptoms and side effects such as rash and anemia, respectively At the same time, the cure rate of sofibvir in clinical trials is only 75%, while the cure rate of sofibvir is more than 90% The staff of hepatitis group of a large pharmaceutical enterprise mentioned that "sofibuprovir has a significant clinical effect, and patients with poor effect of existing standard therapy have a higher demand for it." Colen pharmaceutical industry also said, "sofibvir belongs to the NS5B RNA polymerase inhibitor of direct antiviral drugs, which has a significant clinical effect At the same time, it has therapeutic effect on a variety of HCV genotypes, especially genotype 1, clinical phase III results show that the response rate can be raised to 90% - 95% after three years of continuous use, and the drug-resistant barrier is high, and drug-resistant mutations are rare in clinical practice." At the same time, this "blockbuster" is not cheap It is understood that the current sales price of sofibove in the United States is $1000 / pill (400mg), and a course of treatment needs $84000 A domestic information website quoted about 100000 yuan for a bottle of 400mg × 28 capsules In the case of high efficacy and high price, in December 2013 and January 2014, sofebovir was approved by the FDA of the United States and the European Union, respectively As of the third quarter of 2014, it has achieved sales revenue of 8.67 billion US dollars Some analysts predict that sofibwe is expected to sell more than 10 billion dollars this year, making it the fastest super product in history to sell 10 billion dollars a year Now, Kelun pharmaceutical R & D center and Sichuan Kelun Pharmaceutical Research Institute have applied for the clinical trial of the drug, which means that they will "snipe" the new hepatitis C drug market targeted by the drug According to the relevant person in charge of Kelun pharmaceutical industry, "hepatitis C (Note: HCV) has a relatively large population of patients in China, with a population of 1.3 billion, about 13 million of whom have no response to the standard treatment plan (Note: ribavirin plus interferon mentioned above), and about 7 million of them have no response to the standard treatment plan (Note: genotype 1) Such refractory HCV patients have strong response to new HCV treatment drugs Strong demand According to indications and patient groups, China's market capacity in the future is conservatively estimated at about 100 million yuan " It is still necessary to break the patent barrier In fact, since the beginning of the listing of sofibove, the industry has a strong interest in it However, due to its difficult production and large investment, small pharmaceutical companies are almost unable to bear the burden "The investment of buying original research drugs for analysis and comparison is a huge sum of money for small pharmaceutical companies." A small pharmaceutical company employee mentioned More importantly, after the drug is listed, it will have a long patent period "In order to recover the cost of research and development, pharmaceutical companies will obtain monopoly and pricing rights in the patent period, during which time, the emergence of generic drugs will hardly be allowed It can be seen that the impact of generic drugs on the original research drugs is very large, such as GSK, a Chinese patent for the original research drug, has been greatly impacted by low-cost generic drugs in China after its expiration " "The Chinese market also recognizes the patent protection period, which generally lasts for more than 20 years," said an employee of an overseas pharmaceutical company Therefore, the application of this clinical trial of Kelun pharmaceutical industry may still need to be observed " According to the data, sofibwex has obtained four compound patent authorizations in the United States, with the expiry dates of March 26, 2029 (Note: U.S patent numbers: 7964580 and 8334270), April 3, 2025 (U.S patent numbers: 7429572 and 8415322), respectively In China, sofibwe has temporarily obtained a patent, which will expire on April 21, 2024 (Note: cn 200480019148.4) In response to this question, colen pharmaceutical said, "it is true that sofibove has obtained four compound patent licenses in the United States, but because of the regional nature of the patent rights, the Chinese market is more affected by sofibove's patents in China." At the same time, there are patent disputes in China about the patent which was applied by sofibove on April 21, 2004 and has been authorized Whether the drug can be protected is also affected by the scope of its authorized patent protection In addition, another patent (Note: cn 200880018024.2) applied by sofibwe on March 26, 2008 is still in the stage of substantive examination and has not been granted a patent right "We have been paying close attention to the status and situation of Chinese patents We are preparing to develop products with independent intellectual property rights around sofibove's research and development of new technologies If necessary, we will also solve patent problems in various ways and ways." The head of Kelun pharmaceutical said At present, the core research and Development Institute of Kelun pharmaceutical and Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd of Shiyao group have applied for clinical trials of the drug in China It should be noted that the clinical application of sofibvir is only one of the new drug R & D reserve system of Kelun Pharmaceutical Research Institute Since Kelun pharmaceutical proposed to create a strong product pattern such as infusion and non infusion sectors, its investment in innovation and R & D capacity building has continued to increase, "Kelun invests more than 6% of its sales revenue in R & D every year, and suofebuwei's investment accounts for a small proportion, just a small part of it." Feng Hao, Secretary of the board of directors of Kelun pharmaceutical, mentioned that In recent years, Kelun pharmaceutical industry adheres to the development strategy of "three drives", and continues to develop the whole industrial chain of infusion, antibiotics and high-end drugs In the aspect of new drug research and development, it has attracted the attention of many organizations According to the company's record of investor relations activities, on November 12, CICC and Xinchao capital conducted a survey on Kelun pharmaceutical industry, focusing on the key direction and progress of new drug research and development It is understood that with high-tech drugs as the starting point, the research institute has carried out innovative drug research and development on three major plates: innovative small molecule, biological drug macromolecule and new drug delivery system, focusing on the research and development of major diseases that have not yet met the clinical needs At present, it mainly focuses on solving key technical problems for new drug development organizations such as brand generic drugs, innovative small molecules and biotechnological drugs urgently needed in clinic, and continuously strengthens drug industrialization and marketization, and gradually builds a perfect product line "At present, there are 209 projects in various R & D stages, including 3 innovative small molecule drugs with independent intellectual property rights and 5 biotech drugs." It is worth noting that "since 2013, the research institute has completed the declaration of 68 varieties, among which 20 varieties of anti-tumor, anticoagulant, antiviral and other drugs have achieved the first imitation, with the first opportunity to be listed in China." It is expected that more than 30 projects will be declared in the second half of 2014 " In fact, with the expiration of global patent drugs, generic drugs have become the focus of all pharmaceutical companies, including multinational companies According to CDE, the number of applications for first generic drugs has soared "The rapid growth of new drug applications in the first half of this year is mainly due to the fact that the first generic drugs have become an important field of drug innovation in China," the research group of Debang Securities said "Traditional R & D teams such as Hengrui, Huahai, Kelun and Zhengda Tianqing are still the first tier of leading imitators." "A large number of first new drug R & D reserves will promote the company to seize the historic opportunities of China's generic drugs and provide a stronger impetus for the company's future performance," said Kelun pharmaceutical