PR86293

SUZHOU, China, Oct. 27, 2020 /PRNewswire=KYODO JBN/ --

-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(R) 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(TM) 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