Country for PR: China
Contributor: PR Newswire Asia (China)
Tuesday, October 27 2020 - 11:16
AsiaNet
CStone and EQRx Enter Global Strategic Partnership for Two Immune Checkpoint Inhibitors: sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1)
SUZHOU, China, Oct. 27, 2020 /PRNewswire-Asianet/ --

-CStone to out-license to EQRx exclusive rights to two late-stage 
immuno-oncology assets for development and commercialization outside of Greater 
China 
-Agreement provides a pathway to bring CStone's sugemalimab (anti-PD-L1) and 
CS1003 (anti-PD-1) to global patient communities by partnering with a company 
with an innovative business model and unique ability to commercialize these two 
assets competitively against established treatments 
-Terms demonstrate the significant global commercial potential of these two 
assets and provide immediate cash proceeds to invest in strategic initiatives

CStone Pharmaceuticals ("CStone", HKEX: 2616) announced today an agreement to 
out-license ex-Greater China rights for two key late-stage immuno-oncology 
assets, sugemalimab (anti-PD-L1) and CS1003 (anti-PD-1), to EQRx, a 
biopharmaceutical company with an innovative business model that will allow 
these drugs to be competitively positioned in global markets against 
established treatments for the target indications. 

Under the terms of the agreement, CStone will receive an upfront payment of 
US$150 million and up to US$1.15 billion in milestone payments for both drugs 
as well as separate tiered royalties. EQRx will obtain exclusive rights to lead 
global development and commercialization worldwide, excluding Mainland China, 
Taiwan, Hong Kong and Macau. CStone retains rights to CS1003 in Greater China, 
where it can continue to pursue development as a monotherapy or as part of its 
combination strategy for this drug.  

Frank Jiang, M.D., Ph.D., Chairman and Chief Executive Officer of CStone, said: 
"We are pleased to be partnering with EQRx, an outstanding company led by an 
exceptional management team with a track record of building and investing in 
biotech companies as well as leadership roles at commanding heights of the 
industry. They have a unique blend of expertise to execute on this agreement 
and maximize the global potential of our two lead immuno-oncology assets. "

"This partnership demonstrates the clinical as well as the commercial potential 
of sugemalimab and CS1003. Both are well suited to serve as backbone molecules 
for various combination therapies, an approach that is part of EQRx's vision 
for these drugs. The broad potential to develop combination therapies further 
strengthens our ability to pursue our combo strategy for CS1003 in China. In 
addition, the capital proceeds that we generate through this transaction will 
enhance our ability to invest in strategic development initiatives and advance 
our transition into a fully integrated biopharma company."

Alexis Borisy, Chairman, Founder and Chief Executive Officer of EQRx, said: 
"CStone is recognized globally for excellence in drug development and we look 
forward to advancing their foundational work to expand access to these two 
late-stage, innovative immunotherapies. We believe the addition of PD-L1 and 
PD-1 drug candidates to our expanding clinical pipeline provides EQRx and our 
strategic partners with optionality to deliver high-quality, lower cost 
treatment regimens across a broad range of cancers. Ultimately, adding this 
unique combination of potentially best-in-class immunotherapeutic agents 
advances our mission to deliver equal access to innovative medicines while 
lowering costs for patients, payers and healthcare systems around the world."

Sugemalimab is a potential best-in-class PD-L1 antibody that is being developed 
for high-incidence cancer indications in China, including frontline non-small 
cell lung, gastric and esophageal cancers, among others. The U.S. Food and Drug 
Administration ("FDA") has recently granted Breakthrough Therapy Designation 
("BTD") to this drug for adult relapsed or refractory extranodal natural 
killer/T-cell lymphoma ("R/R ENKTL"), and orphan drug designation ("ODD") for 
T-cell lymphoma. CS1003 is currently being studied for the treatment of 
advanced solid tumors, including a global registration trial in first-line 
hepatocellular carcinoma. The FDA has granted ODD for this indication.

Closing of the agreement is subject to expiration or termination of the waiting 
period under the Hart-Scott-Rodino Act.

Investor Presentation Information 
CStone will host a live webcast at 11:00am (Hong Kong time) October 27th, 2020. 
Please find the access information as below. 

All other regions: 
https://event.webcasts.com/starthere.jsp?ei=1390413&tp_key=e37a82bd34
Mainland China: 
https://event.gmwebcasts.cn/starthere.jsp?ei=1390413&tp_key=e37a82bd34 
Password (case sensitive): CStone

About Sugemalimab (PD-L1)

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by 
CStone. Authorized by a company based in the U.S., Ligand Pharmaceuticals Inc. 
(NASDAQ: LGND), sugemalimab is developed using the OmniRat® transgenic animal 
platform, which can generate fully human antibodies in one stop. As a fully 
human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the 
natural G-type immunoglobulin 4 ("IgG4") human antibody, which may reduce the 
risk of immunogenicity and toxicities in patients, a potentially unique 
advantage over similar drugs. 

Sugemalimab has completed a Phase I dose-escalation study in China. During 
Phase 1a and 1b stages of the study, sugemalimab showed antitumor activity in 
multiple tumor types and was well-tolerated.

Currently, sugemalimab is being investigated in a number of ongoing clinical 
trials. In addition to a Phase I bridging study in the U.S., the clinical 
programs in China include one multi-arm Phase Ib study for several tumor types, 
one Phase II registrational study for lymphoma, and four Phase III 
registrational studies, respectively, for stage III/IV non-small cell lung 
cancer, gastric cancer, and esophageal cancer. The phase III clinical trial of 
sugemalimab in patients with stage IV non-small cell lung cancer has reached 
its primary endpoint. CStone plans to submit a new drug application to the 
National Medical Products Administration of China soon.

About CS1003 (PD-1)

CS1003 is a humanized recombinant IgG4 monoclonal antibody targeting human 
programmed cell death protein 1 (PD-1) being developed for immunotherapy of 
various tumors. Compared to most of the monoclonal antibodies that bind human 
and monkey PD-1 (either already approved or in clinical stage), CS1003 
demonstrates comparable high binding affinities across species against human, 
cynomolgus monkey and mouse PD-1, and is developed to disrupt the interaction 
of PD-1 with its ligands PD-L1 and PD-L2. 

About CStone 

CStone is a biopharmaceutical company focused on developing and commercializing 
innovative immuno-oncology and precision medicines to address the unmet medical 
needs of cancer patients in China and worldwide. Established at the end of 
2015, CStone has assembled a world-class management team with extensive 
experience in innovative drug development, clinical research, and 
commercialization. With a strategic emphasis on immuno-oncology combination 
therapies, the Company has built an oncology-focused pipeline of 15 drug 
candidates, including five late-stage candidates at pivotal trials or 
registration stages. With an experienced team, a rich pipeline, a robust 
clinical development-driven business model and substantial funding, CStone's 
vision is to become globally recognized as a leading Chinese biopharmaceutical 
company by bringing innovative oncology therapies to cancer patients worldwide. 
For more information about CStone, please visit: www.cstonepharma.com. 

About EQRx 

EQRx™ is committed to making innovative medicines at dramatically lower prices 
for the benefit of people and society. By bringing together stakeholders from 
across the healthcare system and utilizing the latest advances in science and 
technology, the company seeks to discover, develop and deliver high-quality, 
patent-protected medicines more efficiently and cost-effectively than ever 
before. Headquartered in Cambridge, Massachusetts, the company is backed by GV, 
ARCH Venture Partners, Andreessen Horowitz, Casdin Capital, Section 32, 
Nextech, and Arboretum Ventures. For more information, please visit www.eqrx.com

Forward-looking Statement 

The forward-looking statements made in this article relate only to the events 
or information as of the date on which the statements are made in this article. 
Except as required by law, we undertake no obligation to update or revise 
publicly any forward-looking statements, whether as a result of new 
information, future events or otherwise, after the date on which the statements 
are made or to reflect the occurrence of unanticipated events. You should read 
this article completely and with the understanding that our actual future 
results or performance may be materially different from what we expect. In this 
article, statements of, or references to, our intentions or those of any of our 
Directors or our Company are made as of the date of this article. Any of these 
intentions may alter in light of future development.

CSTONE INVESTOR CONTACT 
ir@cstonepharma.com 

Source: CStone Pharmaceuticals
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