Industry: Domestic innovative drugs are ushering in a good era of FIC and BIC

【Pharmaceutical Network Market Analysis】In recent years, with the drastic reform of new pharmaceutical policies such as consistency evaluation of generic drugs, normalization of centralized procurement, and medical insurance negotiation, the transformation and upgrading of the pharmaceutical industry has accelerated, and in this context, more and more traditional pharmaceutical companies have laid out innovation + internationalization
.
Innovation is the main theme of the development of the pharmaceutical industry, with the acceleration of China's new drug approval and review, and a series of policies to support the development of pharmaceutical innovation, the number of domestic innovative drug enterprises is showing a year-by-year growth trend
.
According to data from Oriental Wealth Choice, since 2011, 28 pharmaceutical companies have entered the innovative drug sector, doubling
the number of new drugs over the previous 10 years.
Among them, a large number of pharmaceutical companies, including Hengrui Pharmaceutical, Fosun Pharma, and Shanghai Pharma, aim at innovation
.
For example, Hengrui Pharmaceutical actively deploys the field of
innovative drugs by continuously increasing investment in R&D.
As of the end of the third quarter of this year, Hengrui has launched 11 innovative drugs, more than 60 innovative drugs are under clinical development, and more than 260 clinical trials have been carried out
at home and abroad.
Through the establishment of diversified and multi-level innovative cooperation models such as independent research and development, cooperative development, license introduction and in-depth incubation, Fosun Pharma has successively launched a number of innovative products such as artesunate, rituximab injection Hanlikang and Yikada, and the proportion of revenue of innovative products has increased
year by year.
In addition to Hengrui and Fosun, many pharmaceutical companies entering the field of innovative drugs have continued to increase investment in R&D, and the number of new drugs approved in China has reached a record high
.
The data shows that the number of innovative drugs approved for registration by the National Food and Drug Administration (NMPA) increased from 8 in 2016 to 83 in 2021
.
In 2021, the NMPA reviewed and approved 47 innovative drugs, including 5 FIC drugs
.
However, as more and more pharmaceutical companies enter the market, some innovative drug hot tracks have become more and more crowded, and in this context, pharmaceutical companies have to find new ways out, such as internationalization
。 It is understood that since August 2021, when Remegen cooperated with Seagen to develop and commercialize vedicitumab, receiving a down payment of US$200 million and a milestone payment of up to US$2.
4 billion, plus a gradient sales commission of more than 10%, pharmaceutical companies including BeiGene, Junshi Biologics, InnoCare and other pharmaceutical companies have gone overseas to the global market
in recent years through overseas licensing (license out) and other forms 。 For example, on July 28 this year, CSPC announced that it has entered into an exclusive licensing agreement with Elevation Oncology, Inc.
for the development and commercialization of SYSA1801, a first-in-class anti-CLDN18.
2 antibody conjugate, outside of Greater China, under the terms of which CSPC Jushi receives an upfront payment of US$27 million and entitles it to potential development and regulatory milestones of up to US$148 million, and up to 10.
2%.
Potential sales milestone payments of $100 million and the right to receive up to double-digit percentage of sales royalties
based on annual net sales in authorized territories.
On July 26, Kelun Pharmaceutical announced that its holding subsidiary, Sichuan Kelun Botai Biopharmaceutical Co.
, Ltd.
, has reached a cooperation and exclusive license agreement with the US pharmaceutical company Merck Sharp & Dohme to develop an antibody conjugate (ADC) drug
for the treatment of solid tumors.
Merck will pay Colombert an upfront payment of $35 million, various milestone payments of up to $901 million and corresponding net sales commissions
based on the content of the agreement and the commercial development phase.
On May 5, Lixin Pharma announced that the company licensed its self-developed innovative antibody conjugate drug (ADC) LM-302 to Turning Point in the United States, according to the agreement, Turning Point will pay Lixin Pharma an upfront payment of US$25 million, R&D milestone payment of US$195 million and subsequent commercialization milestones, with a total amount of more than US$1 billion
。 The industry believes that behind the license out is the recognition of the innovative research and development capabilities of domestic pharmaceutical companies by multinational pharmaceutical companies, and in the case of intensified competition in the domestic innovative drug market, going overseas is a good choice, and license out is also conducive to domestic innovative drugs going out more quickly
.
It is expected that domestic innovative drugs are ushering in a good era
of FIC and BIC.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.