2022 inventory: those license-out of 'borrowing ships to go to sea'

In order to avoid the congestion of the domestic track, but also to obtain overseas recognition of China's new drugs, going overseas is our only way.

How do you go to sea without a ship? Answer: You can borrow a boat! In this article, the author talks about taking stock of those "borrowed ships" license-out transactions in 2022.

01

Individual amounts of up to US$5 billion (33.9 billion yuan)

In December 2022, Akeso officially announced that it has granted Summit Therapeutics an exclusive license to develop and commercialize Ivosi's development and commercialization in the United States, Canada, Europe and Japan, and Akeso reserves the development and commercialization rights in the above regions. Akeso will receive a down payment of $500 million, and the total amount of the transaction is up to $5 billion!

Evoxi is a dual antibody developed by Akeso, which can block both PD-1 and VEGF pathways, and Evoxi is currently the world's fastest clinically developed PD-1/VEGF bispecific antibody, which is currently in phase III clinical studies.

According to data from phase II clinical studies, the overall response rate of Evoxi in combination chemotherapy for EGFR-TKI-resistant NSCLC patients was 68.4% and mPFS was 8.2 months, compared with 4.3 months for historical controls of current standard therapy (pemetrexed and platinum-containing chemotherapy).

In the past, there were various blockbuster transactions in BeiGene, the "king of license-out", and now there is a sky-high transaction of 5 billion US dollars for Akeso, which must be supported by the clinical data and market of the product, and I expect Ivoxi to have excellent performance in the clinical phase III trial.

02

The total amount exceeds 10 billion US dollars

In December 2022, Kelun Pharmaceutical announced that its holding subsidiary, Kelun Botai, entered into an exclusive license and cooperation agreement with Merck. The agreement targets seven independent ADC projects of Colombert, some of which will grant Merck development and commercialization rights worldwide or outside Chinese mainland, Hong Kong and Macau. The remaining projects, Merck Sharp & Dohme, will be granted exclusive license preferences, and Colombert reserves the right to retain development and commercialization rights in Chinese mainland, Hong Kong and Macau.

Colombert expects to receive a one-time nonrefundable down payment totaling $175 million from the partnership, with milestone payments totaling up to $9.3 billion. Prior to this cooperation, Colombert had reached a license with Merck for two ADC drugs, with a total amount of $2.3 billion.

In less than a year, more than 10 billion dollars in transactions were reached, which is also a significant event in the history of license-out. The deepening of cooperation between Merck and Kelunbotai means that domestic innovative drugs have won international recognition, which also puts a "shot in the arm" for China's innovative drugs to go overseas.

03

Technology platform license-out

Who said that only medicines can go to sea?

In March 2022, Dr. Luo Peizhi, chairman of Tianyan Pharmaceutical, revealed that Sanofi will pay a down payment of US$17.5 million to Tianyan, with a maximum total milestone of US$2.5 billion, mainly for the licensing of Sanofi with the safety antibody SAFEbody technology.

It is worth noting that the deal is not a traditional product license-out, but a technology platform license-out. Although the total milestone amount was $2.5 billion, the down payment was only $17.5 million. Only by deeply unlocking this technology platform can Tianyan Pharmaceutical continue to profit from it.

04

Claudin 18.2 controversy

In July 2022, Stone Medicine Jushi Biologics reached an agreement with Elevation Oncology on the Claudin 18.2 antibody drug conjugate SYSA1801. CSPC reserves its development and commercialization rights in Chinese mainland, Hong Kong, Macau and Taiwan, while the development and commercialization rights in the remaining regions are traded to Elevation Oncology. Jushi will receive an upfront payment of $27 million, potential development and regulatory milestone payments of up to $148 million and potential sales milestone payments of up to $1.02 billion.

Compared to Cologne, Jushi Bio reserves the domestic market for itself, so the transaction amount is reduced. But if SYSA1801 can quickly capture the market in the future, then the deal can be said to be a smart move.

Coincidentally, in 2022, Lixin Pharma entered into an exclusive licensing agreement with Turning Point, under which Turning Point will acquire the development and commercialization rights of LM-302 independently developed by Lixin Pharma in countries and regions around the world except Greater China and South Korea. At the same time, Turning Point paid Lixin Pharma an upfront payment of US$25 million, R&D milestone of US$195 million and subsequent commercialization milestone, totaling more than US$1 billion.

Interestingly, LM-302 belongs to the same Claudin 18.2 ADC drug as the SYSA1801 developed by the above-mentioned stone medicine, and the price is the same, which is really a needle-to-needle wheat. At present, LM-302 is in clinical phase II. and SYSA1801 is in clinical phase I.

Once bleak license out

In fact, the number and amount of license out events can largely reflect the international recognition of innovative drugs in China. For a long time in the past, the license out transaction in our country was quite dismal.

In 2007, Microchip granted the development and commercialization rights of cedarbenamide outside of China to HUYA, the first license out in China, with a total transaction value of $28 million and an undisclosed down payment.

In the following 5 years, China's license out can be described as extremely bleak, and only one product license out in China has been successful in 5 years.

In December 2011, HMP entered into an agreement with AstraZeneca for a total transaction value of US$140 million with an upfront payment of US$20 million.

By 2013, BeiGene was emerging with two license-out deals with Merck Serono.

In 2015, license out transactions gradually increased, and new companies joined them, but no more than 10 transactions per year In June 2017, China officially joined ICH, and since then, China's license out transactions have also shown a spurt of growth.

In 2021, there will be 50~60 license out transactions in China, with a total amount of about 15 billion US dollars. By 2022, the license out transaction between Akeso and Kelun Pharmaceutical alone will reach $15 billion!

From the beginning of 2020 to the end of 2022, China's license out transactions have continued to break through, and the breakthrough of transaction amount year by year shows the recognition of China's new drug license out abroad.

brief summary

All achievements and brilliance are achieved with innovation, knowledge, technology, hard work and hard work.

It is believed that in 2023, China's license out transactions will definitely break the pharmaceutical winter, continue the glory of medicine, and the future license out transactions and amounts will also show a steady rise in the overall trend!