Pharmaceutical companies to observe 丨 Can domestic innovative drugs open up the national market path into the SCO?

The 21st Century Business Herald reporter Zhu Ping, an intern, Lin Yan Xiao. Beijing reported that with the rapid development of Chinese pharmaceutical companies, going to sea has become a popular choice for domestic pharmaceutical companies. Gan Li Pharmaceuticals, Yasheng Pharmaceuticals, Nuohui Health, Baiji Shenzhou and other companies have looked at overseas markets and actively promoted their outlets in clinical trials and listing.

In the choice of overseas markets, in addition to the European and American markets with developed pharmaceutical industry and perfect market rules, Chinese pharmaceutical companies have also set their sights on the emerging countries market. Among them, in recent years, the cooperation between the members of the Shanghai Cooperation Organization in the medical field has become closer and closer.

Not long ago, the SCO member country held a pharmaceutical cooperation conference in the field of pharmaceutical cooperation under the Framework Framework of the SCO -Shanghai Cooperation Organization Medical Cooperation Development Conference. Support to strengthen drug supervision and exchanges and cooperation, actively promote the establishment of more efficient and win -win international drugs and medical device research and development cooperation models under the framework of the SCO organization, promote the supervision and cooperation of international drug approval, and use key products and fields as the breakthrough. The market is prosperous.

On September 16, data released by the Ministry of Commerce of China showed that in 2021, the trade volume of other member states of China and the SCO reached US $ 343.3 billion, an increase of 40%year -on -year, which was 28 times that of the SCO's establishment in 2001. In the first seven months of this year, the trade volume of other member states of China and the SCO was US $ 226.8 billion, a year -on -year increase of 25%.

At present, the cooperation in the field of pharmaceuticals in China and the SCO countries has had a certain impact in these countries. Biezov, chairman of Kyrgyzstan MIKS Company, told a reporter from the 21st Century Business Herald that Kyrgyzstan is one of the countries that can quickly register Chinese drugs and have accumulated rich experience in promoting Chinese drug production enterprises to enter the CIFC market. Kyrgyzstan is willing to play the role of bridges to promote cooperation in the field of training.

In response to the problems faced in the cooperation between the SCO's pharmaceuticals, professionals from the pharmaceutical enterprises and the pharmaceutical regulatory department recommend that they have recommended to establish a unified regulatory mechanism. For Biezov's development of pharmaceutical cooperation, it is recommended that the SCO countries can sign a multilateral agreement as the basis of the laws and regulations. In the agreement, the relevant regulatory general rules, requirements and standard systems must be stipulated in the agreement, and there must be a uniform standard in terms of drug supervision. The Pakistani Pharmaceutical Bureau Mohammed Fahedin told the 21st Century Business Herald that under the SCO Organization, more regulatory coordination and regulatory action can be adopted.

Innovative medicine goes to the sea to emerging markets

Over the past few decades, Chinese pharmaceutical companies have gone through the process of developing generic drugs to imitation, to innovative medicines. At the same time, it has also gone through the development process from China to overseas. Especially after China joined the International Human Pharmaceutical Registration Technology Coordination Association (ICH), the Chinese pharmaceutical review and approval system accelerated with international standards to expand the overseas market strategy. Become a popular choice for domestic pharmaceutical companies' innovative drug layout.

In an interview with the 21st Century Business Herald, Wu Xiaoying, a co -supervisor partner of the Life Science and Health Industry of Ernst & Young University, said that going to sea is a big trend. Domestic companies must get out of this single market. , To form a positive cycle. Companies of different stages and characteristics need to lay out and plan the strategy of going to the sea as soon as possible, from early cooperation development to sharing of equity, and balance opportunities and risks through different models.

At present, many pharmaceutical companies have aimed their attention to the European and American markets, but in addition to the "breakthrough" FDA and EMA, domestic pharmaceutical companies have also turned their attention to emerging markets. Emerging market coverage is wide and populated with a wide range of market spaces. In the past, whether it was local or multinational enterprises in the past, it has not fully paid attention to and in -depth development.

For example, Ganli Pharmaceutical has promoted the strategic layout of internationalization since 2005. In the world, including the United States and Europe, the Asia -Pacific, the Middle East, North Africa, Central South America, CIS, Southara and other countries and regions, glyphosate insulin injection in the world and regions Lai Preserved Prefecture Injection, insulin injection pen, insulin injection needle and other all series of diabetic therapy products.

At present, more than 50 clinical trials in China, the United States, Australia and Europe are underway. In addition, clinical trials have also begun to conduct clinical trials in Ukraine, Russia, Poland, Hungary and Eastern European countries. Its 2021 report shows that the company has successfully established global cooperative relations with leading biotechnology and pharmaceutical companies and academic institutions, which has also accelerated the company's commercial layout of overseas markets.

Yang Dajun, chairman of Yasheng Pharmaceutical, pointed out in an interview with the 21st Century Business Herald that the globalization of innovative drugs cannot just rely on the US market, but also to see the needs of regions such as the "Belt and Road". According to reports, Yasheng Pharmaceutical also launched a specified patient drug use plan (NPP, named patient program). The plan is similar to the Boao model of Hainan. It aims to provide the opportunity to use the drug to designate the drug to designate the drug, which plans to cover more than 130 countries and regions to accelerate the needs of patients in the world.

In the choice of emerging countries markets, it is worth noting that the cooperation between the members of the Shanghai Cooperation Organization in the medical field is getting closer and closer.

According to the Ministry of Commerce, China is the largest trading partner of Russia and Pakistan, the second largest trading partner of Kazakhstan, Uzbekistan, and Kyrgyzstan. In September 2021, in the "Tenth Anniversary of the Tenth Anniversary of the Shanghai Cooperation Organization" signed by the leader of the SCO member states, the heads of state of the members of the member state agreed that in the prevention of infectious diseases, epidemic monitoring, non -infectious chronic disease prevention, mother -in -law, mother -in -law It is of great significance to continue cooperation in infant health. Zhang Ming, Secretary -General of the Shanghai Cooperation Organization, said that all parties of the Shanghai Cooperation Organization attach great importance to cooperation in the field of medical and health. First of all, the mechanism of cooperation has been improved, and various mechanisms such as the Minister of Health of the member states and the head of the epidemic prevention department play an important role in responding to the new crown epidemic. Secondly, the legal foundation is more complete, and the intergovernmental health cooperation agreements, key cooperation plans in the field of health, and health cooperation measures are effectively implemented. In addition, all member states have continuously strengthened cooperation in the research and development and production of remote medical care and new crown pneumonia vaccines. With the support of all parties, China promoted the international Guangming operation of healthy express for patients with cataracts for free. , Organize a seminars of Cerebral Paraception Rehabilitation Network.

The unified supervision mechanism is to be established gradually

In the view of Song Ruilin, the executive chairman of the China Pharmaceutical Innovation Promotion Association, Chinese pharmaceutical companies can achieve win -win cooperation with various forms such as technological cooperation, market expansion, and investment factories through cooperation with the relevant national governments and industries.

At the same time, Song Ruilin also expressed his hope that all parties would work together to promote the establishment of a normalized communication and cooperation platform between pharmaceutical and health regulatory agencies and the pharmaceutical industry under the framework of the upper -intensive organizational framework. On this platform, the promotion of medical products with clinical value of various countries, and provides convenience for drugs that meet the common recognition standards.

In addition, the relevant person in charge of domestic innovative pharmaceutical companies told the 21st Century Business Herald that there is a lot of room for cooperation between Chinese pharmaceutical companies and SCO countries. In recent years, China's innovative drugs have developed very quickly, especially in the most popular field of immunotherapy PD-1 drugs. China's innovative drugs have a huge advantage in price, but only 20%-30%of the price of drugs in the world, which benefit patients.

According to the above-mentioned person in charge, PD-1 has been approved to be listed in China, and it uses ICH international standards. Enterprises can prepare a complete set of data such as clinical trial data, pharmacological data, and quality data as required. State regulatory authorities.

But can the PD-1 product data specific in the SCO countries achieve mutual recognition of supervision?

In this regard, Mohammed Faheldin, the director of the Pakistani Pharmaceutical Bureau, believes that this is equivalent to a mechanism of mutual recognition and dependence. However, Pakistan also has its own technical committee and review center who also needs to check the products.

"However, the product has been approved to be listed in other countries. We will use these information that has been approved as an important reference, and then discuss some details, such as what kind of drug fields to start, what paths, which paths, and which ones are used. The country's pharmaceutical regulatory authorities have participated in, what review and approval standards are adopted, "Mohammed Faheldin pointed out.

In response, Biezov also said that Kyrgyzstan was one of the earliest countries to achieve rapid registered Chinese drugs. It has accumulated rich experience in promoting Chinese pharmaceutical manufacturers to enter the CIS drug circulation market. Biezov hopes that all parties will organize relevant joint training activities in Kyrgyzstan. Kyrgyzstan has a geographical advantage and facilitates to establish close connections with other joint countries. Kyrgyzstan is willing to play the role of bridges to promote cooperation in the training field.

It is understood that Kyrgyzstan established two centralized centers before the epidemic, the centers of Kyrgyzstan and China, which are mainly concentrated in the development of high -tech field cooperation. It can also incorporate cooperation in the field of pharmaceuticals.

At the same time, Biezov also said that for the development of medical cooperation, the SCO state can sign the multilateral agreement as the basis of the law and regulations. In the agreement, the relevant regulatory general rules, requirements and standard systems must be stipulated in the agreement. standard. Don't mention the establishment of an institution or committee in the SCO framework to unify the regulatory standards, especially in the field of pharmaceutical circulation. "You can establish a training center to jointly formulate training plans for experts from different disciplines to provide related training for drug production and circulation enterprises for export to allow these companies to understand each other, so that there will be a smooth market access channel."

Mohammed Faheldin believes that under the SCO Organization, more regulatory coordination and regulatory areas can be adopted. , Help improve understanding. In addition, under the framework of the SCO, more information exchanges and communication mechanisms can be set up. Chinese pharmaceutical companies can invest in the SCO countries, especially Pakistan, to establish a joint venture, and can also cooperate with local pharmaceutical companies. In addition, in terms of clinical trials, a technical team can be established to study and coordinate clinical trial requirements of various countries.

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