Recently, local pharmaceutical companies such as WuXi Biologics, Akeso, and Kelun Pharmaceutical have all reported good news about license-out, which has once again boosted the confidence
of domestic innovative drugs to enter the international market.
On January 5, 2023, WuXi Biologics announced that it has entered into a licensing partnership with GSK to acquire exclusive global research, development, manufacturing and commercialization rights for one preclinical bispecific antibody and up to three other early-stage TCE antibodies
.
Through the transaction, WuXi Biologics will receive an upfront payment of US$40 million and research, development, registration, and commercialization milestones for four TCE antibodies of up to US$1.
46 billion, and will be eligible for a tiered sales commission based on net sales
.
On December 6, 2022, Akeso announced that it will grant Summit Therapeutics exclusive license rights to develop and commercialize PD-1/VEGF bispecific antibody AK112 in the United States, Canada, Europe and Japan
.
Under the agreement, Akeso will receive a $500 million down payment
.
Including development, registration and commercialization milestone payments, the total value of the transaction is expected to reach up to US$5 billion, which also sets a new record for the overseas licensing of innovative drugs in China (which was soon broken by Colombotai).
On December 22, 2022, CLOMPAT announced that it has licensed seven different preclinical ADC candidate candidates in its pipeline to MSD, a transaction that will result in an upfront payment of US$175 million, in addition to a significant milestone
of up to US$9.
3 billion.
.
.
.
.
.
.
Looking back on 2022, in fact, domestic innovative drugs have encountered many setbacks
when they go overseas.
For example, in February 2022, Innovent failed to pass the US FDA's Oncology Drug Advisory Committee (ODAC) for Cindilimab; In May 2022, the FDA required Junshi Biologics to make a quality control process change for teripulimab, and in May, Hutchison announced that the FDA had not approved its marketing application for sulfatinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors; In July 2022, BeiGene's partner Novartis mentioned in its second quarterly 2022 report that it had not submitted a U.
S.
marketing application
for tislelizumab monotherapy for non-small cell lung cancer after receiving feedback from the FDA.
However, although domestic innovation has encountered setbacks, it has also provided reference experience
for Chinese pharmaceutical companies to go overseas.
At present, local pharmaceutical companies are showing more and more courage, such as the relevant person in charge of BeiGene has said that since 2022, the external environment is indeed full of uncertainty
.
It must be faced that the development process of China's innovative drugs is short, and there is still a gap
between China and the traditional innovative drug countries.
However, in the long run, there is still sufficient confidence
in the development of the innovative drug industry.
The industry expects that the general trend of domestic innovative drugs going overseas will not change
in 2023.
Southwest Securities once pointed out in a research report that innovative drugs are ready to go overseas, and the vast world has great achievements
.
Analysis, on the one hand, some of the domestic hot tracks have become more and more crowded, the market competition is increasingly fierce, taking PD-1 as an example, the four major PD-1 products including Junshi Biologics, Innovent Biologics, BeiGene, Hengrui Pharmaceutical have entered medical insurance, the price has dropped significantly, and there are more PD-1 products on the track have been approved for marketing, on July 22, 2022, Lepu Biotech's putelimab was approved, which means that the 10th PD-1 monoclonal antibody
was ushered in in China.
On the other hand, for emerging local pharmaceutical companies committed to the research and development of innovative drugs, internationalization and overseas expansion are a major trend
.
In recent years, with the continuous increase in R&D investment of domestic innovative pharmaceutical companies, the pipeline under research has gradually transformed from Fast-Follow, Me-Too to First-in-Class, and the competitiveness of internationalization has been continuously improved.
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