In the next ten years, the internationalization of innovative pharmaceutical companies will become the trend of development!

【Pharmaceutical Network Market Analysis】In the past 10 years, under the encouragement and promotion of national policies, Chinese pharmaceutical companies are accelerating their transformation from imitation to innovation
.

It is worth noting that in the field of biomedicine, local innovative pharmaceutical companies have also set off a "tide of going to sea"
.

The "White Paper on Chinese Pharmaceutical Companies Going Overseas" pointed out that in 2020, China's innovative drugs have entered the outbreak period of "going to sea", and local innovative pharmaceutical companies are sailing to the "deep sea" of globalization in the form of "group army", of which the number of innovative drugs "going to sea" in the form of License out is as high as 39, and the cross-border transactions between local pharmaceutical companies and overseas pharmaceutical companies have accumulated 271, achieving an increase of 300%
in five years.

Since the beginning of this year, China's innovative drugs "going to sea" are still accelerating
.

On April 6 this year, BeiGene announced that its application for marketing of its PD-1 monoclonal antibody, terelizumab, had been accepted
by the European Medicines Agency.

At the end of February, the CAR-T cell therapy product of Legendary Biotech of Kingsway was approved in the United States, becoming the first successful "going to sea" cell therapy product, which encouraged
the industry.

There are also some innovative drugs that have not yet been listed, and are also accelerating the "going to sea" through the form of overseas authorization, and there are many large pharmaceutical companies such as Novartis, AbbVie, Roche, and Pfizer among the "payers
".

In May this year, Kelun Pharmaceuticals, which is transforming into an innovative pharmaceutical company, licensed its biomacromolecular oncology project A to Merck for commercial development outside of China, with milestone payments totaling no more than US$1.
363 billion and a percentage of net sales agreed upon by both parties
.

On July 28, CSPC Pharmaceutical Group announced that it has entered into an exclusive licensing agreement
with Elevation Oncology, Inc.
for the development and commercialization of SYSA1801, a first-of-its-kind anti-CLDN18.
2 antibody-coupled drug outside greater China.

Under the terms of the agreement, its subsidiary, CSPC Jushi Biotech, will receive a down payment of US$27 million and will be entitled to up to a potential development and regulatory milestone payment of up to US$1.
08 billion and a potential sales milestone payment
of up to US$1.
02 billion.

At present, local pharmaceutical companies are still actively laying out overseas clinical trials and certification
.

It is understood that in the past three months (May 10-August 30), more than 18 pharmaceutical companies in Shanghai and Shenzhen have obtained news from the FDA, which is related to the product obtaining the fda drug clinical trial implied license, obtaining drug registration approval, obtaining approval number, etc.
, of which a large number of domestic drugs have now won FDA certification
.

On July 21, after being awarded the breakthrough therapy and orphan drug qualification by the US Food and Drug Administration (FDA), its self-developed anti-PD-1 monoclonal antibody drug Treprimumab for the treatment of nasopharyngeal carcinoma was awarded the orphan drug qualification by
the European Commission.

On July 28, CSPC's innovative drug docetaxel (albumin-binding type) for injection was granted by the FDA as an orphan drug for the treatment of gastric cancer, including esophageal gastric junction cancer
.

At present, docetaxel for injection has entered a number of key clinical studies in China, and has carried out Phase I studies in the United States.
.
.
It is worth noting that in the past six months, from Innovent Biology, Junshi Biology to BeiGene, more or less have encountered a lot of setbacks in going to sea, although domestic new drugs have cost-effective advantages, but in the case of strict FDA review, product clinical progress and indications development are not dominant, want to go to sea smoothly is also facing great challenges
.

It is understood that in February this year, Innovent Biologics' xindilimonumab broke through the US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) failed
.

In May, the FDA requested Junshi Bio to make a change in the quality control process for tripleimumab; In July, BeiGene's partner Novartis allegedly did not submit an application for
the U.
S.
listing of non-small cell lung cancer for the Terelizumab monodrug after receiving FDA feedback.

In this regard, the industry believes that at present, the internationalization of local pharmaceutical companies is still in the exploratory stage, and the progress of pharmaceutical research in the target country and the changes in regulatory approval requirements are putting forward higher requirements for domestic pharmaceutical companies, including clinical trial design capabilities, domestic and foreign clinical trial promotion capabilities, and communication capabilities with regulators
.

However, the twists and turns of the moment cannot change the general trend
of the internationalization of domestic innovative drugs.

For local innovative pharmaceutical companies, internationalization will become a very important theme in the next decade, and only by learning from setbacks and having real innovative research and development capabilities in the future can we better promote domestic innovative drugs to go overseas
.

Disclaimer: In no event shall the information or opinions expressed herein constitute investment advice
to any person.