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“Zhangjiang Creations” are frequently exported. Why do Americans insist on using Chinese new drugs?

2024-07-28

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Summary:Zhangjiang has truly arrived on the international stage of the life science industry.


Qiantan, a new business district in Shanghai, has attracted more than 330 companies to settle in recent years. Among these companies, the industry with the largest number of companies is life sciences.

A global real estate service agency revealed that moving into Qiantan, where high-end office buildings are lined up, is the choice for foreign biopharmaceutical companies to demonstrate their strength. Today, many local companies nurtured by Zhangjiang have also taken root here. They use their strength to tell people that Zhangjiang pharmaceutical companies are becoming the world's top companies.

If we count from the opening of Zhangjiang High-tech Park in 1992, Zhangjiang has only been under construction for 32 years. However, Zhangjiang's industries have indeed completed the solid foundation over time. Biomedicine is just one of Zhangjiang's industries. Its revenue in January-May this year reached 66 billion yuan, a year-on-year increase of 11%. Zhangjiang has become the region with the most concentrated biomedical R&D institutions, the strongest innovation capabilities, and the most outstanding innovation achievements in China.

Of course, expanding the scale of the industry cannot fully cover the value of Zhangjiang to the construction of the national industrial system. Today, when some countries want to implement "decoupling and breaking the chain" and build "small courtyards with high walls", Zhangjiang is shouldering the important mission of promoting the construction of a healthy China through scientific and technological self-reliance. From last year to now, Zhangjiang's original new drugs have been "going overseas" one after another; in the first half of this year, Zhangjiang was approved for 2 domestically produced Class 1 new drugs, accounting for two-thirds of Shanghai. On the international stage of the life science industry, Zhangjiang has really arrived.

Zhangjiang's new drugs frequently go overseas

There is a "double ten rule" in the field of new drug research and development, which means that a new drug requires an average of ten years and up to one billion US dollars in investment. Perhaps ten years ago, looking at Zhangjiang pharmaceutical companies, those entrepreneurial teams that were still working hard were mediocre. In the past two years, Zhangjiang, as the source of new drugs in China, has officially entered a period of harvest.

On June 22 this year, Hutchison MediPharma announced that its independently developed new anti-tumor drug furiquintinib has been approved by the European Commission for the treatment of previously treated metastatic colorectal cancer.

Half a year ago, on November 9, 2023 Beijing time, the first prescription of furiquintinib, which was approved in the United States, was issued within 48 hours.

This is the first small molecule drug approved by the United States for the treatment of metastatic colorectal cancer in nearly a decade, and it is also the first time that Zhangjiang's new drug has been prescribed in an overseas pharmaceutical market.

Hutchison Medicine is one of the earliest companies in Zhangjiang to carry out new drug research and development. Even the initial small molecule structure of furiquintinib was drawn on a napkin by the company's R&D staff in a cafe in Zhangjiang.

After being launched in the United States, fruquintinib was quickly accepted by patients. According to data released by Takeda, fruquintinib's sales in the U.S. market exceeded US$50 million in the first quarter of 2024 alone.

The essence of China's new drug development is to enable Chinese people to have independent and controllable drug research and development capabilities. However, it is undeniable that the surge in "big numbers" is strengthening China's international voice in pharmaceutical research and development technology - as of the end of last year, my country had 146 innovative drugs developed and launched in the past 10 years, accounting for 15% of the world's total, and new drugs under development accounted for 33% of the world's total, second only to the United States.

Today, although many domestic pharmaceutical companies are still facing export difficulties caused by the international environment, the momentum of Zhangjiang's new drugs going global cannot be stopped by human power. Just before furiquintinib "went overseas", another Zhangjiang pharmaceutical company Junshi Biosciences developed Teplizumab, which also successfully landed in the US market. It is not only my country's first self-developed and self-produced innovative biological drug approved for marketing in the United States, but also fills the gap in the treatment of nasopharyngeal carcinoma in the United States.

Not long ago, Zhangjiang company Haihe Pharmaceutical also announced that its innovative MET inhibitor GUMETINIB tablets, which has global independent intellectual property rights, has been approved for marketing by the Ministry of Health, Labor and Welfare of Japan, becoming the first innovative drug approved for marketing in Japan by a Chinese biopharmaceutical company.

Zhangjiang Medicine is truly benefiting the world.


Jingtai AI Robot Laboratory conducts drug development experiments.

The incubation system is becoming more and more perfect

The booming life science industry in Zhangjiang did not come about out of nowhere.

At Pudong Gongli Hospital, a prostate hyperplasia surgery is in progress. The doctor skillfully uses laser output equipment to seal the hemostatic point, alleviating the patient's pain and reducing the risk of the surgery.

This laser output device was independently developed by Raycoon, a medical device company in Zhangjiang. The patient on the operating table would not know that more than 10 years ago, it was just an ordinary science and technology company. Today, Raycoon has not only created laser equipment with independent intellectual property rights that breaks the import monopoly, but also recently started construction of a 30,000 square meter headquarters and research and development base in Pudong. It is expected to be put into production in 2027, with an annual output value of 960 million yuan.

From small to big, from obscurity to a blockbuster, this is the true story of many Zhangjiang pharmaceutical and medical device companies. Behind the "cool" growth, personal efforts are indispensable, and the support of the environment cannot be ignored.

After 32 years of development and accumulation, Zhangjiang now has 158 innovation carriers of various types and nearly 3,000 incubated enterprises. The city announced the first batch of 7 high-quality incubators, 5 of which are from Zhangjiang.

"Zhangjiang Hi-Tech 895 Incubator" (hereinafter referred to as 895) is also a business card for the innovation industry. It provides an all-weather science and technology innovation community that integrates entrepreneurial incubation, living, office and supporting facilities, allowing entrepreneurs to focus on scientific research.

Liu Xianghua, the founder of Maiqiaoli, was incubated here when he first came to Zhangjiang to start a business in 2019. After the core technology products were verified, he won the Pudong Industry-University-Research Project and completed the A round of financing with the help of 895.

Zhangjiang has now formed an ecological pattern with large, medium and small enterprises at different stages of development. Small enterprises can enter incubators and accelerators for innovation, or rely on large enterprises for support.

Shanghai Roche Pharmaceuticals was the first foreign investment project introduced to Zhangjiang in the 1990s. Roche leads the industry development and also cares about sustainable innovation. Just last year, Roche invested nearly 300 million yuan in the world's first self-built and operated accelerator in Zhangjiang. As of June this year, nearly 20 local start-ups have settled in the accelerator, with research directions covering various biological mechanisms such as protein degradation and phase separation, and various drug forms such as cyclopeptides and cell therapy.

In addition, more than 20 large companies, including Johnson & Johnson JLABS@Shanghai and Siemens Medical Device Innovation Center, have also established open innovation centers in Zhangjiang, leveraging the technology, capital, and platform advantages of large companies to empower start-ups, and have cultivated and accelerated more than 200 companies.


Roche China Accelerator Laboratory.

After several rounds of reforms, we will start again

On May 15 this year, the State Drug Administration approved the marketing of the first-in-class innovative drug, Rizitinib Mesylate Capsules, applied for by Pudong pharmaceutical company Beierda Pharmaceutical Co., Ltd.

Hu Xueqin, vice president of Beierda Pharmaceuticals, said: "We invested nearly 1 billion RMB in total in the development of this drug. Compared with the previous investment of 1 billion USD, this can be regarded as a new drug that was completed in a 'fast, good and economical' way, thanks to the institutional innovation of Zhangjiang."

The institutional innovation mentioned by Hu Xueqin is the reform demand "drug marketing authorization holder system" that Zhangjiang first proposed as early as 2011. In 2015, Zhangjiang became one of the key parks in the first batch of pilot provinces and cities in the country, and soon the first Class 1 new drug to be launched through the MAH pilot was born - Hutchison MediPharma's furiquintinib. In 2018, the pilot was expanded to the field of medical devices. Today, the two pilot results have become the core content of the new version of the "Drug Law" and "Medical Device Supervision Regulations".

Biomedicine has gone through multiple stages of industrial development in Zhangjiang. From the earliest strategic layout of the national team to the wave of overseas returnees, from the gathering of multinational R&D companies to the continuous emergence of local R&D companies, the institutional environment has also been iterating while the industry is iterating.

At the end of 2016, Zhangjiang Cross-border Science and Technology Innovation Supervision Service Center was established. As the first customs supervision place for air cargo outside the airport area in Shanghai, the center adopts a direct-through mode, shortening the customs clearance time from 2-3 working days to 6-10 hours. Enterprises can complete the procedures of cargo owner's order drawing, customs declaration, physical confirmation at the checkpoint, inspection, and delivery in one stop, which effectively accelerates the cross-border R&D process of enterprises.

In July 2020, Pudong New Area took the lead in launching a pilot reform of joint supervision of special entry of biopharmaceuticals in China. During the pilot period, a total of 11 companies passed the "white list" for special entry, and a total of 108 batches (more than 60,000 bottles) of special items were imported by white list companies.

On the basis of a smooth and controllable pilot, in October 2023, the "Several Provisions of Pudong New Area on Promoting the Regulatory Services of Special Bio-pharmaceutical Items Entering and Leaving the Country" was promulgated and implemented. The management method of special bio-pharmaceutical items was changed from "white list" management to conditional management, effectively solving the problem of difficulty in entering the country for special items used for research and development of enterprises.

After several rounds of institutional reforms, Zhangjiang this year has returned to the starting point to think about the key issues of industrial system construction. Not long ago, Shanghai Pudong Life Science Industry Development Co., Ltd., led by Shanghai Zhangjiang (Group) Co., Ltd., was officially established. In the future, this team will focus on the life science industry, based in Zhangjiang, and concentrate on serving the entire life cycle of the biopharmaceutical industry in Pudong New Area, and radiate to drive the development of the biopharmaceutical industry in other areas of Pudong. It will link enterprises, universities, scientific research institutions, large scientific facilities, government regulatory departments and many clinical institutions, help Pudong form a high-quality clustered development model for the biopharmaceutical industry, and allow more innovative drugs to be born in Zhangjiang, building a higher level of global industrial ecosystem.


Overlooking Zhangjiang.