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November 7, 2018

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Prognosis for pharma: healthy times ahead

Multinational drug companies are applauding China’s efforts to open its market wider and embrace global health-care standards.

“Opening-up and reform in the past decades have not only brought in foreign capital, but also the latest technologies, the best practices in manufacturing and quality control, and higher levels of management experience,” said Luo Jiali, general manager of Boehringer Ingelheim Biopharmaceuticals China.

The German-based parent company was selected as one of the first foreign companies to be included in China’s biopharma “contract manufacturing organization” pilot project. The trial allows domestic and overseas drug companies to outsource manufacturing and early-phase research and development work to eligible third parties.

Luo said there was no such thing as outsourcing in the manufacture of medicines when the company first decided to set up a production site and lab in Shanghai six years ago.

The new model means that local pharma firms no longer have to set up their own manufacturing facilities, a cost burden that many can’t bear.

Boehringer Ingelheim was one of the earliest pharmaceutical companies to offer outsourcing services for both local and foreign drug firms. The company said it is adopting advanced technologies as a forerunner to the new business model.

For example, single-use technology and continuous manufacturing facilities were first adopted in its Shanghai site ahead of three other sites in the United States and Europe.

Earlier this year, the National Medical Products Administration of China, formerly the China Food and Drug Administration, accepted an application from Chinese pharma firm Beigene for a new lymphoma drug. Clinical, manufacturing and quality-control corroborating information was provided by Boehringer Ingelheim’s lab in Shanghai.

Beigene’s new drug is expected to become the first approved by Chinese authorities under the Market Authorization Holder trial program.

That program aims to accelerate commercial production of new medications, especially those developed by startup firms.

Last year, China became a member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The organization aims to raise standards across all aspects of pharmaceutical regulation.

“In the past two years, China’s Center for Drug Evaluation has cleared a drug evaluation backlog and pushed implementation of drug-evaluation reforms,” health-care analyst Zhao Bing at UBS Securities said in a research note.

Some 9,680 drug filings were processed in 2017, reducing the backlog to 4,000 from as many as 22,000 two years ago.

Multinational drug companies typically started business in China by importing medicines already approved on the market in overseas countries and regions.

China is also implementing a fast-track approval process to get drugs in high demand for the treatment of cancer, cardiovascular diseases and respiratory ailments to the market as soon as they are safely possible.

As one of the fastest-growing foreign pharma businesses in China, UK-based pharma giant AstraZeneca is forging ties with local partners to provide innovative business models.

AstraZeneca’s latest effort has been in disease management solutions covering every aspect of a patient, including disease prevention, diagnosis, treatment and rehabilitation.

The company is leveraging Internet of Things technologies to offer solutions to its business partners.

French company Sanofi is pledging 60 million yuan (US$8.6 million) in financial aid for startups in the next five years as part of China’s “Internet-plus health care” initiative.

The company is inviting startups to collaborate in areas of patient management, medication adherence and digital-assistant robots. Similar efforts have also been initiated by German multinational Bayer to combine the strength of the latest mobile technologies with its health-care businesses.

The company has initiated incubator programs in the past three years to evaluate pharma startups to support Chinese innovation in digital health and nutrition fields.


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