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Although China's generic drugs started late, the future can be expected

Time：2022-08-05 15:07:21 Source： Author：

China and India are both large generic drug producers. After years of development, China's pharmaceutical production capacity ranks first in the world. The consumption structure is mainly domestic, and the international market share is small. According to the data of China Chamber of Commerce for the import and export of medical and health products (hereinafter referred to as the medical insurance chamber of Commerce), China's total export of preparations in 2020 was US $4.93 billion, of which the amount of preparations exported to the United States was US $680 million. India is the world's largest exporter of generic drugs, with obvious advantages in internationalization. According to the data of India pharmaceutical Export Promotion Association, the total export volume of generic drugs in India was 18.85 billion US dollars from 2020 to 2021, of which generic drugs exported to the United States accounted for about 30% of its total export volume.

The United States is the largest generic drug market in the world, and the largest market for the export of Chinese and Indian preparations is the United States. As far as the U.S. market is concerned, the internationalization of generic drugs in China and India is different in terms of industrial development logic, first generic drugs and patent challenges.

Actively expand the U.S. market

In the 1970s, the Indian government successively issued a series of policies, such as "canceling pharmaceutical and chemical patents", "restricting the shares of foreign-funded enterprises" and "raising tariffs to restrict imports", to restrict the development of multinational pharmaceutical enterprises in India and promote the rapid development of domestic pharmaceutical enterprises. In particular, India's strong imitation policy has directly promoted the take-off of the country's generic pharmaceutical industry. With the surge in the number of generic pharmaceutical enterprises, the intensification of competition in the Indian pharmaceutical market, and the government's strict restrictions on drug prices, India became one of the countries with the lowest drug prices in the world in the 1980s. In order to survive and develop, some Indian enterprises actively plan to go to sea. It coincided with the introduction of the drug price competition and patent period Recovery Act (also known as hatch Waxman act) in the United States in 1984, which opened the golden age of the development of generic drugs in the United States. In the same year, Indian xipula company began to explore the American market. Indian pharmaceutical enterprises attach great importance to resource integration. As more and more Indian pharmaceutical enterprises go to the United States in a group and catch up with the policy dividend of the great development of the American generic drug market, the development momentum of Indian generic drugs is strong.

After the reform and opening up, China's pharmaceutical industry has developed rapidly. In the early stage, the strategy of "market for technology" made foreign pharmaceutical enterprises develop rapidly in China. With the rapid economic growth and the gradual expansion of the scale of medical and health expenditure, China's generic pharmaceutical industry has entered a rapid and barbarous growth stage of low-level repetition. The "supporting medicine by medicine" has promoted the false high price of drugs, and the industry has formed a tendency of "marketing is king". The quality level of domestic generic drugs is uneven, but enterprises can rely on flexible sales means to find gold in the domestic market. At that time, domestic pharmaceutical enterprises did not have the driving force to "go global". From 2000 to 2015, many leading pharmaceutical companies gradually tried to seek the development of overseas markets. After July 2015, the State Drug Administration issued a series of policies and measures to encourage new drug research and development, and strengthened the docking of China's drug regulatory regulations with the international market, creating more possibilities for domestic pharmaceutical enterprises to expand the American market. Compared with India, Chinese pharmaceutical enterprises have long relied on domestic market dividends to enter the U.S. market late, and more opportunities need to be further explored.

Accelerate the approval of preparations

Indian pharmaceutical enterprises are familiar with the regulatory regulations and market rules of the United States, especially in the production of documents and document management. To a certain extent, they even surpass the local pharmaceutical enterprises in the United States. Therefore, the number of applications for approval of generic drugs in the United States is far ahead of that in China. From 2010 to 2019, the number of generic drug registration applications (anda) approved by Indian pharmaceutical companies accounted for more than 35% of the total number approved by the U.S. Food and Drug Administration (FDA). India sun pharmaceutical alone has more than 400 approved anda. Indian pharmaceutical companies have formed a rich product pipeline in the United States, and the sales of generic drugs in the U.S. market has become the main source of revenue for Indian pharmaceutical companies.

Chinese enterprises started late. In 2007, nevirapine of Huahai Pharmaceutical Co., Ltd. became the first Chinese preparation variety certified by FDA, and Chinese pharmaceutical enterprises officially opened the road to expand the U.S. market. According to the data of the medical insurance chamber of Commerce, from 2006 to 2010, only 6 Chinese pharmaceutical companies successfully registered with anda in the United States; From 2010 to 2014, the average number of Anda approved in the United States for Chinese preparations was only about 20. Since 2015, the number has increased rapidly. In 2020, Chinese pharmaceutical enterprises received more than 80 anda approvals in the United States. Although the number increases rapidly, the approved dosage forms are relatively single, mainly oral preparations and injections. At present, the Chinese pharmaceutical enterprise with the largest number of Anda approved in the United States is Huahai pharmaceutical. As of April 6, 2022, the enterprise has accumulated 74 anda documents.

At present, FDA has greatly increased the declaration cost of generic drugs. At the same time, with the intensification of competition in the U.S. generic drug market and the decline of generic drug prices, Indian enterprises are also transforming to less and more refined generic drugs in the United States. Chinese enterprises should learn to increase the varieties of generic drugs approved in the United States at the lowest cost.

The first generic drug has become the main direction

As the general generic drug market in the United States has become a red sea, many enterprises have turned their attention to the first generic drug. FDA generally gives priority to the evaluation of the first generic drug. The price of the first generic drug can reach about 70% of the price of the original drug, and the first generic drug with successful patent challenge will have a 180 day market monopoly period. In 2001, Prozac tablets with a dose of 40mg developed by Dr. Reddy of Indian pharmaceutical industry became the first imitation drug harvested by Indian enterprises in the United States. With rich experience in drug imitation and familiarity with U.S. regulations, Indian pharmaceutical companies continue to challenge new drug patents and compete for the first imitation in the United States, and have repeatedly achieved success. Taking Dr. Ruidi as an example, by the end of March 2018, 63 of the 107 anda projects under review had been challenged with patents, and 30 were the first to submit.

In 2014, prasugrel of dongyangguang pharmaceutical became the first generic drug approved in the United States. In 2017, Huahai pharmaceutical's paroxetine capsule became the first generic drug in China to successfully challenge the PIV patent in the United States. According to the statistics of the medical insurance chamber of Commerce, a total of 46 enterprises were approved 95 first generic drugs in the United States in 2019. Among them, Indian pharmaceutical companies have achieved more than 30 first imitations, accounting for nearly one third of the total; Only xuantai pharmaceutical, a Chinese pharmaceutical company, obtained the first imitation of posaconazole enteric coated tablets.

"The world's martial arts, only fast not broken." Only by winning the first imitation can we get rich returns in the U.S. market. With the continuous progress of generic drug conformity evaluation, Chinese enterprises are increasingly developing generic drugs in accordance with the unified technical standards of the International Coordinating Committee for the registration of human drugs and the global evaluation system. It is believed that the development and production of the first generic drugs with high barriers in the future will also become the main direction of the development of Chinese pharmaceutical enterprises in the U.S. market.

Carry out international mergers and acquisitions and capital operation

The reason why Indian generic pharmaceutical companies can develop into international giants is inseparable from their active mergers and acquisitions. Through continuous mergers and acquisitions, Indian pharmaceutical companies have increased the number of Anda approvals, rapidly expanded the scale of generic drugs, formed rich product pipelines, and gradually established strong market barriers. Take sun pharmaceutical as an example. Since the first acquisition of the API production base of knol l Pharma, a multinational pharmaceutical company, in 1996, sun pharmaceutical has acquired 16 companies, including 5 mergers and acquisitions involving the U.S. market. At present, the company has become the largest generic pharmaceutical enterprise in India in the United States.

Chinese generic pharmaceutical enterprises are relatively conservative in overseas mergers and acquisitions. Since 2016, Chinese pharmaceutical enterprises have begun to implement overseas mergers and acquisitions on a large scale. In 2016, Huahai pharmaceutical acquired Charlotte factory in the United States; In the same year, humanwell pharmaceutical acquired epic Pharma with us $529 million, and obtained many anda approvals through this acquisition. In 2017, Fosun Pharmaceutical successfully acquired Indian pharmaceutical company gland Pharma at a cost of US $1.091 billion. It is reported that by 2020, the number of Anda owned by gland Pharma of Fosun Pharmaceutical Holdings and its partners in the United States has exceeded 260.

International M & A is an accelerator for the international development of enterprises, and it is also an important factor for Indian pharmaceutical companies to open the gap with their Chinese counterparts in the U.S. market.

Create a localized industrial chain ecosystem

Generic drugs will eventually be listed and profitable in the U.S. market, involving research and development, international registration, certification, market access and marketing system. Indian pharmaceutical companies are familiar with FDA rules, with fast research and development speed, strong declaration ability, many clinical institutions that meet FDA requirements, and relatively low labor costs and hospital bed costs. Indian enterprises have been operating in the U.S. market for many years and have a full understanding of the sales rules of generic drugs in the United States. Some mainstream distributors also have Indian managers. Indian enterprises have formed a complete industrial ecosystem of R & D, production and sales in the United States, which paves the way for Indian companies' products from development to commercialization. Take Dr. Ruidi as an example. He has been rooted in the United States for many years, forming a complete industrial chain and a relatively complete sales system. His products can be quickly put on the market after being approved in the United States.

Internationalization is not achieved overnight. From the approval of Anda to the realization of commercial profits, Chinese pharmaceutical enterprises still have a long way to go. How to choose the sales mode of approved products and how to quickly solve various regulatory problems after listing are difficult problems that need to be solved step by step for Chinese pharmaceutical enterprises that have not yet formed a sales system in the U.S. market.

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Although China's generic drugs started late, the future can be expected