Health & Beauty

On January 15, Greenleaf Pharmaceutical released an announcement that its independently developed new drug Rykindo (risperidone sustained-release microsphere injection preparation) was officially approved by the United States Food and Drug Administration (FDA) for listing. This is China's first category 1 innovative chemical drug for treating depression that is independently developed and has independent intellectual property rights. It is also the first domestic CNS (central nervous system) innovative product approved overseas.

On January 31, Baike Biological announced that the company recently received the Drug Registration Certificate of live attenuated herpes zoster vaccine issued by the State Drug Administration. This is the first domestic herpes zoster vaccine on the market. Previously, only one herpes zoster vaccine was listed in China, which was imported by GlaxoSmithKline for international trade.

While the number of new drug applications in China has increased steadily, some innovative drugs have continuously achieved "zero" breakthroughs in their respective fields, which is a strong evidence of the continuous improvement of China's innovative drug research and development capacity.

In view of the international trade situation of western medicine products this year, Cao Gang, director of the Western Medicine Department of the China Chamber of Commerce for International Trade and Import of Pharmaceutical and Health Products, pointed out that although the external environment is still grim in 2023, driven by favorable factors such as the optimization and adjustment of domestic epidemic prevention and control policies, the global economic recovery, and the recovery of R&D and innovation, China's innovative medicine industry will usher in new opportunities and promote the high-quality "going out" of China's western medicine products to take new steps.

There are still rough and dangerous beaches

In 2022, the COVID-19 and many uncertainties in the international situation will have a certain impact on the operation of foreign trade of Chinese western medicine products. From the perspective of customs data, the import and export of Chinese crude drugs in international trade maintained a good growth; The export of western medicine preparations is relatively stable, and the import has declined slightly; Biochemical drugs showed a trend of decreasing export demand and increasing import, and the export of anti-epidemic drugs continued to decline.

Cao Gang said that in 2023, China's foreign trade of western medicine products will face many risks and challenges, whether it is to observe the internal and external environment or the "microclimate" of the industry.

At present, the risk of world economic recession is rising, the growth of foreign demand is significantly slowing, the international supply chain pattern is also accelerating the restructuring, and the foreign trade development environment is extremely severe. The prices of basic production factors such as oil, coal, metal, grain and so on have continued to rise. The raw materials needed for the production of the pharmaceutical industry and the transportation costs for the export of international trade have also risen, especially for the export of bulk raw materials that compete for overseas markets by relying on price advantages. In terms of the international market environment, Chinese pharmaceutical enterprises often face problems such as weak local infrastructure, difficult implementation of preferential policies, and disorderly market competition in the process of developing emerging markets such as Latin America, Africa, and the Middle East. In addition, some countries are difficult to handle visas, and the issuance rate is low, which affects the business expansion of enterprises.

From the perspective of the industry's own development, the pace of enterprise transformation and upgrading needs to be further accelerated. According to Cao Gang, while relying on regulatory norms and market guidance to promote the transformation and upgrading of pharmaceutical enterprises, the phenomenon of low gross profit and overcapacity of traditional bulk raw materials still exists. And with the decline in the international demand for anti-epidemic drugs and the gradual deepening of the policies of many countries to support the localization of the pharmaceutical industry chain, China's export model based on bulk raw materials is expected to continue to grow healthily and needs to be transformed. At the same time, "although the innovation and development of China's preparation industry has made great progress, there is still a gap between China and the world's first echelon." Take vaccines as an example. In addition to the soaring export of COVID-19 vaccine in 2021, China's import and export of human vaccines have maintained a trade deficit for many years, and there is still some import dependence in high-end vaccine fields such as four price and nine price human papillomavirus. The vaccine trade deficit in 2022 will be US $2.942 billion, an increase of US $1.437 billion compared with 2019.

In addition, the regulatory pressure faced by pharmaceutical enterprises at home and abroad will continue to tighten. The pharmaceutical industry is a strongly regulated industry. On the whole, even in 2022, when the epidemic prevention and control is tight, the pharmaceutical industry still maintains the trend of stricter policy supervision. In 2023, the frequency of the introduction of medical policies may be accelerated, and the implementation time will be more compact. Internationally, the European Commission has updated a series of regulatory documents such as the GMP appendix of imported drugs, clinical trial regulations, etc., and has more stringent requirements on the product quality assurance, data disclosure and transparency of enterprises. In March 2022, the United States Congress requested FDA to carry out a pilot plan to increase on-site inspection of overseas drug production. In 2023, FDA may resume some overseas on-site inspections. This is both an opportunity and a challenge for China to expand the export of raw materials and preparations to the United States.

Stable and quality improvement

In the face of the complex economic and trade situation, the Chinese government is constantly increasing its reform efforts, and pharmaceutical enterprises are also actively seeking new development in the changing situation.

Enterprises take the initiative to seek change, diversify and diversify the international market. Cao Gang observed that while many of China's leading innovative pharmaceutical enterprises and traditional pharmaceutical enterprises are entering developed markets such as Europe and the United States, they are also carrying out international cooperation in various forms such as equity investment, mergers and acquisitions, license-out (overseas licensing), commercial licensing, and actively layout emerging markets such as Southeast Asia, the Middle East, and Latin America. Chinese pharmaceutical enterprises have set up more R&D centers overseas, deeply participated in the global R&D network, and further expanded the scope and depth of simultaneous registration and application at home and abroad.

The policy continues to promote industrial development. Since 2022, a series of policies and measures to stabilize foreign trade and foreign investment have been introduced in succession to promote the stable development of pharmaceutical foreign trade in many aspects, such as enterprise rescue, financing support, credit insurance, trade facilitation, etc; The "Fourteenth Five-Year Plan" for the Development of Bioeconomy, the "Fourteenth Five-Year Plan" for the Development of Pharmaceutical Industry and other programmatic documents have been issued successively, indicating the upgrading and development path for China's pharmaceutical industry; The State Drug Administration has repeatedly taken new measures to explore the establishment of a scientific regulatory system, providing regulatory policy support for the improvement of drug regulatory capacity and the promotion of high-quality development of the industry

"China's pharmaceutical industry is in the transition period after the implementation of new laws and regulations and the adaptation period after the adjustment of powers. The support and guidance of policies and a solid and complete industrial foundation are the 'stabilizer' for the high-quality development of pharmaceutical foreign trade." Cao Gang believes that this year, both the transformation and upgrading of traditional raw materials and preparations, as well as the development of innovative drugs and biological products, will make steady progress, improve quality and achieve new development.