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In the past two years, domestic innovative drugs are accelerating the process
of going overseas.
Compared with the domestic market, the overall innovative drug market in Europe, the United States and Japan has a broad space and stronger ability to pay
.
Cooperate with overseas companies to license
OUT can not only complement each other's advantages at the R&D end, reduce the risk of new drug R&D, but also use the sales network of international large pharmaceutical companies at the sales end to enable domestic innovative drugs to enter the international market
faster.
The following is an inventory of innovative drugs in the field of oncology in China in 2021-2022
License out Trading Top5, share
with you.
TOP5：TROP2 ADC
TOP5：TROP2 ADCOn May 16, 2022, Kelun Pharmaceutical, its holding subsidiary (70% equity), signed an amendment to the license agreement with Merck, under which KelunBotel licensed SKB264, which has independent intellectual property rights, to Merck for commercial development
outside China (China includes Chinese mainland, Hong Kong, Macau and Taiwan).
Colombert received a one-time, non-refundable payment of $17 million upon the effective date of the license agreement and a one-time, nonrefundable payment of $30 million upon the signing of the amendments to this agreement, with milestone payments not exceeding $1.
363 billion in aggregate and a percentage of net sales agreed by both parties
.
Kelun Pharma was able to obtain a total license amount of US$1.
41 billion from Merck Sharp & Dohme due to its high commercial value
.
SKB264 is an ADC targeting TROP2, a human trophoblast surface antigen that is highly expressed in a variety of solid tumors, including breast, lung, gastric, colorectal, pancreatic, prostate, cervical, head and neck and ovarian cancer, which means that its potential clinical application fields are broad.
SKB264 adopts fixed-point coupling to improve the controllability and safety of ADC.
The ADC is confered with a lysable linker effect, increasing its therapeutic effect
.
In theory, SKB264, which is similar in design to Trodelvy, has relatively controllable R&D risks and has the potential for
better clinical benefits.
At present, SKB264 is conducting phase II clinical trials for multiple tumors in China and the United States, and phased clinical data
have been obtained.
TOP4：PD-1
TOP4：PD-1On January 13, 2021, BeiGene announced a collaboration and licensing agreement with Novartis for the development, manufacturing and commercialization of its self-developed anti-PD-1 antibody drug Bezean (tislelizumab) in multiple countries, with an initial payment of up to US$650 million and a total transaction value of more than US$2.
2 billion.
The countries involved in this authorization cooperation and authorization include the United States, Canada, Mexico, member states of the European Union, the United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan
.
The two parties will jointly develop tislelizumab in the above countries, of which Novartis will be responsible for the registration application in these countries after the transition period and carry out commercialization activities
after approval.
BeiGene's sales in China in the first three quarters of 2022 were US$128.
2 million, up 67% from the same period last year, and it has achieved three consecutive quarters of growth
this year.
In terms of going overseas, Baizean has submitted new drug marketing applications in many countries, covering many important fields
such as esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (NSCLC).
According to the financial report, Novartis plans to submit to the US FDA a new indication application
for the first-line treatment of gastric cancer, first-line treatment of unresectable ESCC and first-line hepatocellular carcinoma (HCC).
TOP3：HER2 ADC
TOP3：HER2 ADCOn August 8, 2021, Remegen entered into an exclusive global license agreement with Seagen to develop and commercialize its ADC new drug, vedicitumab
.
Remegen will generate a total of $2.
6 billion in potential revenue from the transaction, including a $200 million down payment and a milestone payment of up to $2.
4 billion, while Remegen will receive a gradient sales commission
on vedicitumab net sales in the Seagen region from high single digits to more than ten percent.
Seagen has acquired global development and commercialization rights for vedicitumab outside of Remegen's region, and Remegen will retain the rights
to conduct clinical development and commercialization in Asia (excluding Japan and Singapore).
Vedicitumab is the first self-developed ADC drug targeting HER2 in China, which has potential
in clinical trials for the treatment of gastric cancer, urothelial cancer, breast cancer and other tumors.
On June 9, 2021, the drug was approved for marketing by the China Food and Drug Administration, and the current indications include gastric cancer and urothelial cancer
.
In the 2022 half-year report, the sales of vedicitumab were about 84 million yuan
.
In May 2022, a US Phase II clinical trial of vedicitumab began to evaluate the efficacy and safety
of vedicitumab alone or in combination with pembrolizumab in the treatment of locally advanced or metastatic urothelial carcinoma expressing HER2.
TOP2: TIGIT inhibitors
TOP2: TIGIT inhibitorsOn December 21, 2021, BeiGene announced an option, partnership and licensing agreement with Novartis to jointly develop, manufacture and commercialize BeiGene's investigational TIGIT inhibitor Ociperlimab
in North America, Europe and Japan.
Under the agreement, BeiGene will receive a cash advance of $300 million from Novartis and an additional $600 million or $700 million when Novartis exercises an exclusive, time-based option during 2023, subject to obtaining required antitrust approvals
.
In addition, as Novartis exercises its option, BeiGene is entitled to receive up to $745 million in policy approval milestone payments, $1.
15 billion in sales milestone payments, and royalties
based on Ociperlimab's sales in licensed territories.
Ociperlimab is a potent TIGIT inhibitor under development with complete Fc segment function
.
The Fc segment is critical
for the anti-tumor activity of TIGIT antibodies.
However, so far, no drugs targeting TIGIT have been approved for marketing in the world, and the success of BeiGene's TIGIT inhibitors is unknown
.
In September this year, phase I data were published for Ociperlimab in combination with tislelizumab in the treatment of NSCLC (non-small cell lung cancer), and the overall ORR (unconfirmed) of 39 patients whose efficacy could be evaluated was achieved
53.
8%, the PD-L1 high expression group (PD-L1 TC≥50%) ORR was 71.
4%, and the 1-49% low expression group ORR was 44.
0%.
In the cross-sectional comparison, Ociperlimab's ORR was higher than Roche's TIGIT monoclonal antibody
Tiragolumab, however, Roche abandoned its "PD-L1+TIGIT" combination first-line therapy for NSCLC by announcing in May that its Tiragolumab did not meet the primary endpoint of PFS
.
TOP1: PD-1/VEGF dual antibody
TOP1: PD-1/VEGF dual antibodyThe most important thing must be that on December 6 this year, Akeso licensed Summit Therapeutics AK112 (Evosi's PD-1/VEGF bispecific antibody).
Under the agreement, Akeso will receive an upfront payment of US$500 million, which is expected to reach US$5 billion
when added to development, registration and commercialization milestone payments.
Summit
Therapeutics will receive an exclusive license
to develop and commercialize Ewoci in the United States, Canada, Europe and Japan.
Akeso will receive a low double-digit percentage of net sales as royalties for Ewosi, and will also own Ewosi's co-branded rights
in these regions overseas.
AK112 can be said to be the most highly anticipated product of Akeso, and it is the PD-1/VEGF bispecific antibody
with the fastest clinical development progress in the world.
Previously, Ewoxi has been recognized as three breakthrough therapies by the National Medical Products Administration of China
.
At present, AK112 is doing some excellent clinical data in the head-to-head clinical trial of the world's first anti-cancer drug Keytruda, and the future complete data is expected to help Akeso cut into the PD-L1-positive NSCLC melee and other solid tumor fields, and will have tens of billions of years of sales imagination space in the future
.
This is one of the
reasons why it can sell for such a sky-high price.
Resources:
Resources:
1.
2.
https://baijiahao.
baidu.
com/s?id=1749022243307059152&wfr=spider&for=pc 2.
https://baijiahao.
baidu.
com/s?id=1749022243307059152&wfr=spider&for=pc
3.
https://pdf.
dfcfw.
com/pdf/H3_AP202209051578041830_1.
pdf?1662386076000.
pdf
https://pdf.
dfcfw.
com/pdf/H3_AP202209051578041830_1.
pdf?1662386076000.
