Generic drugs need to reduce costs to find features
“In addition to strict quality control, the generic drug companies will also seek their own market positioning and form their own product characteristics.” On September 23, at the 2015 BT Leaders Summit, “Exploring the New Situation in China” At the forum of the innovative approach of pharmaceutical companies, Dr. Tang Lijuan, President and Chief Scientist of Pharmula Laboratories, advised on the innovation of Chinese pharmaceutical companies.
On August 18, the State Council officially issued the "Opinions on Reforming the Examination and Approval System for Pharmaceutical Medical Devices" (hereinafter referred to as "Opinions"), one of which aims to improve the quality of generic drugs and encourage the development of innovative drugs. At the forum, experts at the meeting generally believed that after the implementation of the drug trial reform, Chinese pharmaceutical companies will gradually become less and more refined, and generic enterprises will face severe challenges after raising the industry threshold, and innovative pharmaceutical companies will usher in R & D, approval and other multiple benefits.
Modified new drugs must have clinical value
China's modern pharmaceutical industry started late and the standard is low. Over the years, the state has taken measures such as concentrating locally approved drugs to the national unified examination and approval, improving the level of GMP certification, and promoting the evaluation of the quality and efficacy of generic drugs and original drugs to improve the quality of drugs.
On August 18th, the "Opinions" introduced the drug review standards and redefine the concept of new drugs and generic drugs. The new drugs were divided into innovative drugs and improved new drugs. The generic drugs were copied from the existing national standards. The drug is adjusted to "a drug that is consistent with the quality and efficacy of the original drug." Wang Zeren, head of Shenzhen Nanda Pharmaceutical Technology Research Institute and Shenzhen Hualikang Biomedical Co., Ltd., said that the improvement of generic drug evaluation standards will force the innovation of generic drugs to improve the quality of generic drugs and improve them. New drug.
"Developing and improving new drugs must have clinical value." Wang Zeren said that the specific performance is to improve the efficacy, improve safety, reduce toxicity, improve patient compliance, or improve patient convenience. In short, it is new. Clinical Value.
Under the new policy situation, how can a generic drug factory survive to survive in the long run? "When domestic generic drug companies first entered the United States, American marketing companies said that they would like to find a large company's drugs to copy, which can be copied. Is it true that Chinese companies are not vying for big American companies.” She suggested that generic drugs should not be copied to large companies. At the same time, in the imitation process, it is necessary to produce products of the same quality and bioequivalence as the original research drug, and the equal quality is achieved by strict GMP management.
In addition, generic drugs should go the low-cost route. "A lot of companies start with cost-free imitation, but in the long run, they can't control the cost." Tang Lijuan said, so if a generic drug company wants to survive for a long time, it must control costs, so that it can really have a competitive advantage in price. This is also the most important factor for generic companies to survive.
The core of generic drugs is in the R&D team.
The core of generic drugs is the R&D team. Enterprises need to establish their own R&D team with their own technical expertise and technology platform. Dr. Tang Lijuan particularly emphasized that “similar drug companies must have their own product characteristics and do what others have not done, and many of these pharmaceutical companies are not doing enough. Most of the generic factories are swarming, and others do what I do. What, pharmaceutical companies should do market analysis."
In this regard, the R&D team must first be familiar with the market sales. To understand the product requirements of the market, including the color, shape and annual sales of the products, these are important requirements in the design. Tang Lijuan said that the R&D team is led by the preparation experts, but the most important work is actually in the analysis team. When the basic preparations are initially selected, it is necessary to estimate the difficulty and cost of the research and development, which is a key point for whether the whole preparation is copied.
"If the generic drug is the first pharmaceutical, the original pharmaceutical company, regardless of how you do it, infringes the patent, will certainly sue you, the purpose is to stop you first." Tang Lijuan also suggested that the company must have its own patent attorney, The provision of legal assistance and protection by enterprises should be taken seriously.
"Life-saving drugs" must speed up the approval process
With the promulgation of the "Opinions", pharmaceutical companies' innovations also ushered in opportunities. However, in the face of more stringent drug quality supervision, high-quality listed companies generally have a strong quality management system, or will benefit from the industry norms as a whole. Li Jianke, head of Shenzhen Tiandao Pharmaceutical Co., Ltd., believes that with the further increase in industry concentration, leading pharmaceutical companies with innovative capabilities and rapid layout capabilities will quickly seize the market high. At the high-end dialogue of the BT Leaders Summit, many experts also focused on accelerating the development of new drugs.
“The government encourages innovation, and new drug development should meet clinical needs.” Peng Jian, a reviewer of the Drug Evaluation Center of the former State Food and Drug Administration, expressed concern about the current innovation of Chinese pharmaceutical companies. At the same time, he also suggested that the country's new drug approval process should be more flexible, taking into account the urgency of clinical needs.
"Now a lot of life is gone every day, because the development cycle of 'life-saving medicine' is too long." Zhu Xun, chairman of the famous immunologist and new medicine talent club, also said that the country should speed up the approval process of new drugs and let patients eat as soon as possible. On the "life-saving medicine." (Jilin Qijian Biotechnology Co., Ltd., Qijian Bio, Biopharmaceutical, www.qjbio.com.cn)