Up to $5 billion Akeso enters into a partnership and licensing agreement with Summit Therapeutics

• On December 6, 2022, Akeso announced that it will grant Summit Therapeutics an exclusive license to develop and commercialize Evosi's (PD-1/VEGF bispecific antibody) in the United States, Canada, Europe and Japan.
  Akeso reserves the rights to develop and commercialize Ivosi except in the above regions, including China
  .
  
• Akeso will receive a $500 million down payment
  .
  Including development, registration and commercialization milestone payments, the transaction is expected to total up to $5 billion
  .
  At the same time, Akeso will also receive a low double-digit percentage of net sales as a royalty
  for Evesi.
  Dr.
  Yu Xia, Chairman of Akeso, will be appointed to the Board of Directors of
  Summit Therapeutics.
  
• The conclusion of this cooperation paves a fast and winning path for the global development and
  commercialization of Evisi.
  Summit Therapeutics has a team of industry-leading drug development experts and has successfully brought more than a dozen indications of the world's first blockbuster drug, IMBRUVICA® (ibrutinib), to market
  .
  
• The terms of this agreement fully demonstrate the huge global commercialization potential of Evaci, further replenish Akeso's cash reserves, and fully support the company's subsequent drug development and strategic development process
  .
  

HONG KONG, Dec.
6, 2022 /PRNewswire/ -- Akeso (HKEx: 9926.
HK, hereinafter referred to as "Akeso" or the "Company") is a commercial-stage biopharmaceutical company dedicated to the development of internationally initiated and best-in-class new drugs
.
The Company today announced that it has signed a collaboration and license agreement with Summit Therapeutics Corporation (NASDAQ: SMMT) ("Summit") to license the development and commercialization
of its breakthrough bispecific antibody Evosius (PD-1/VEGF, AK112) in the United States, Canada, Europe and Japan (the "Licensed Territories").
Akeso reserves the rights to develop and commercialize Ivosi except in the above regions, including China
.
At the same time, the company has co-branded rights
to the product in the agreement license area of SUMMIT.

Iwosi (R&D code for China and Australia: AK112; Summit licensed regional R&D code: SMT112) is a potential world's first bispecific antibody independently developed by Akeso, which can block PD-1 and VEGF pathways at the same time, and can exert immune effects and anti-angiogenic effects
at the same time.
This innovative antibody structure design effectively reduces the side effects and safety issues
associated with drug treatment.
To date, no PD-1-based bispecific antibody has been approved
by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Evosi is currently the world's fastest clinically developed PD-1/VEGF bispecific antibody
.

Currently, Akeso is conducting a phase III clinical study of evosi monotherapy versus pembrolizumab monotherapy in patients with PD-L1-positive non-small cell lung cancer (NSCLC), and a phase III clinical study
of evoxi plus chemotherapy in EGFR-TKI-resistant EGFR-mutated EGFR mutations with advanced non-squamous NSCLC 。 Evoxi has been recognized as a breakthrough therapy by the National Medical Products Administration of China, including the above two indications, and in combination with docetaxel for the treatment of patients with previously PD-(L)1 inhibitors and platinum-containing chemotherapy for resistant locally advanced or metastatic NSCLC
.

As shown in data presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, in a Phase II study, the overall response rate (ORR) of patients with EGFR-TKI-resistant NSCLC treated by Evosi in combination with chemotherapy was 68.
4% and median progression-free survival (mPFS) was 8.
2 months, compared to 4.
3 months
for the historical control mPFS of current standard therapy (pemetrexed and platinum-containing chemotherapy).
。 In the other cohort, evocy plus docetaxel for patients resistant to PD-(L)1 and platinum-biagent chemotherapy had an mPFS of 6.
6 months, compared with 4.
5 months
for historical controls with current standard treatment docetaxel monotherapy.
Similar to receiving Evoci in combination with chemotherapy as first-line therapy, the study confirmed a tolerable safety profile and low adverse event-related discontinuation rates
.

"Previous clinical data has demonstrated that Ivoxi has great potential
to deliver superior clinical benefits to patients.
" Dr.
Yu Xia, co-founder, chairman, CEO and president of Akeso, said, "Over the past 8 years, the Akeso team has devoted itself to the research and development of Evosi, and successfully advanced it to the clinical phase III research stage
.
At this moment, the global value of Evesi awaits the cooperation between Akeso and the outstanding team
.
We are excited to partner with a leading team like Summit who have rapidly brought to market
more than a dozen indications for the world's first blockbuster drug IMBRUVICA® (ibrutinib).
In recent months, Akeso and Summit have conducted close and in-depth consultations on strategic, scientific and operational aspects, and we are confident
in the success of Ewosi's global development.
We firmly believe that with a high level of commitment from both parties, Ewosi will achieve successful development and commercialization on a global scale as quickly as possible, benefiting patients worldwide
.
" "

Robert W.
Duggan, Chairman and CEO of Summit Therapeutics, Inc.
, is pleased to say, "This collaboration with Akeso is an attractive strategic business opportunity
.
Akeso's exceptional team has built a comprehensive innovation engine for new bispecific technologies, while the Summit team has a proven track record of success in global clinical development, regulatory approval, and commercialization, particularly in oncology
.
We have reason to believe that this partnership will unleash great potential
for innovation.
We are very pleased to see the effective improvement
in the quality of life and survival benefits shown by the Ivoxi clinical data.
Summit is honored to partner with Akeso, our shared mission and vision
to deliver differentiated and innovative therapies that deliver significant clinical benefits to patients around the world.
" "

"We have focused on many potential opportunities in the field of solid tumors in the past, and this time we finally have the ideal collaboration to bring disruptive clinical benefits to patients, with unlimited potential
to change the existing treatment landscape.
" Dr.
SUMMIT, Co-CEO and President Maky Zanganeh adds, "Ten years ago, survival for relapsed and refractory lung cancer was rarely longer than 10 to 12 months
.
Today, patient survival begins in years
.
Our goal is to improve the quality of life and extend the benefits of our patients' survival, and patient-centricity is at the heart of our philosophy
.
We have also been actively seeking and enriching our product pipeline to bring better therapies
to patients.
We will invest in advancing the development of Iwosi firmly and quickly so that it can be brought into the hands
of patients as soon as possible.
We are very excited to reach an agreement with Akeso and Dr.
Xia's team and work together
to realize this vision.
" In the past few months of close cooperation, Summit and the Akeso team have established a deep cooperative relationship, and I am very grateful to the Akeso team and Summit for their efficient progress, which ultimately led to this meaningful cooperation
.
" "

Based on this agreement and terms, Akeso will receive an initial payment
of $500 million.
Including development, registration and commercialization milestone payments, the transaction is expected to total up to $5 billion
.
At the same time, Akeso will also receive a low double-digit percentage of net sales as a royalty
for Evesi.
Summit will be granted the development and commercialization rights
of SMT112 in the United States, Canada, Europe and Japan.
Akeso will retain the right
to develop and commercialize Ivosi, except for Summit-licensed areas, including China.
Dr.
Yu Xia, Chairman of Akeso, will be appointed to the Summit Board of Directors
.