PR93814

SUZHOU, China, Dec. 21, 2021 /PRNewswire=KYODO JBN/ --

CStone Pharmaceuticals (the "Company" or "CStone") is pleased to announce that

the National Medical Products Administration ("NMPA") of China has approved the

new drug application ("NDA") of anti-PD-L1 monoclonal antibody Cejemly(R)

(sugemalimab) in combination with chemotherapy for treatment-naïve metastatic

(stage IV) non-small cell lung cancer ("non-small cell lung caner" or "NSCLC")

patients.

Key Highlights

-Anti-PD-L1 monoclonal antibody Cejemly(R) approved in combination with

pemetrexed and carboplatin as first-line treatment of patients with metastatic

nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; and in

combination with paclitaxel and carboplatin as first-line treatment of patients

with metastatic squamous NSCLC.

-It is the first anti-PD-L1 plus chemotherapy approved for the first-line

treatment of metastatic non-squamous and squamous NSCLC patients worldwide.

-The NDA of Cejemly(R) in stage III NSCLC is under regulatory review, and the

product has the potential to provide an anti-PD-L1 monoclonal antibody option

for both stage III and stage IV non-small cell lung cancer patents in the

future.

-Cejemly(R) is CStone's third new drug approval in China in 2021, following two

first-in-class precision medicines GAVRETO® and AYVAKIT®.

Globally, the incidence of lung cancer continues to rise, and it is still the

leading cause of cancer death worldwide, with huge unmet medical needs.

According to statistics, there were 2.21 million new lung cancer cases

worldwide in 2020. NSCLC accounts for about 85% of all lung cancer cases, and

about 66% of patients are diagnosed with stage III/IV NSCLC. According to

IQVIA's Global Oncology Trends, the size of global oncology drug market is

estimated to reach US$269 billion by 2025, of which immuno-oncology drugs will

contribute about 20%.

Dr. Frank Jiang, Chairman and CEO of CStone, said: "Cejemly(R) is our third

approved new drug in China this year. This further demonstrates CStone's

ability and track record in developing and commercializing high-quality new

drugs. As a drug supported by China's national science innovation program,

Cejemly(R) is a globally leading anti-PD-L1 monoclonal antibody. We will work

closely with Pfizer to leverage resources and advantages of both sides to

accelerate commercialization so that more Chinese patients can benefit from

this innovative therapy soon."

Professor Caicun Zhou, Principal Investigator of the GEMSTONE-302

registrational phase III clinical study of Cejemly(R) and Director of the

Department of Oncology, Shanghai Pulmonary Hospital, said, "The latest data

show that Cejemly(R) plus chemotherapy further prolonged progression-free

survival ("PFS") of treatment-naïve patients with stage IV NSCLC. Compared with

chemotherapy alone, Cejemly(R) plus chemotherapy demonstrated durable survival

benefits with lower toxicity and immunogenicity risks. With a unique dual

mechanism of action, Cejemly(R) mobilizes both T cells and macrophages to

destroy tumor cells. Therefore, Cejemly(R) is expected to reshape the landscape

of lung cancer treatment."

Dr. Jason Yang, Chief Medical Officer of CStone, said, "We are thrilled that

Cejemly(R) has been approved in Mainland China. It took only four years for

Cejemly(R) to obtain the first NDA approval in lung cancer from the initiation

of the phase I clinical trial in humans. It comprehensively showcased CStone's

robust clinical strategy, innovative trial design and rapid execution, while

once again demonstrating the 'CStone Speed'. We will continue to work with our

partner to pursue regulatory discussions for Cejemly(R) on the NDAs of stage

III and stage IV NSCLC with regulators in multiple countries and regions,

including the U.S. Food and Drug Administration, and bring this innovative

immunotherapy to more lung cancer patients soon. We will also continue to

advance the registrational studies of Cejemly(R) in esophageal squamous cell

carcinoma, gastric cancer, relapsed/refractory extranodal natural killer/T-cell

lymphoma, to benefit more cancer patients."

The NMPA approval is based on the positive data of GEMSTONE-302 study, a

multi-center, randomized, double-blind, phase III study that evaluated the

efficacy and safety of Cejemly(R)or placebo in combination with chemotherapy in

first-line stage IV NSCLC patients. Compared with placebo plus chemotherapy,

Cejemly(R) plus chemotherapy lowered the risk of disease progression or death

by 52%, significantly prolonged the patients' PFS and an encouraging trend in

overall survival ("OS") was observed. The clinical benefit was irrespective of

NSCLC pathologies and PD-L1 expression levels. Cejemly(R) has a well-tolerated

safety profile, and no new safety signals were found.

Apart from the approved indication, the NMPA accepted the NDA of Cejemly(R) as

consolidation therapy in patients with unresectable stage III NSCLC without

disease progression after concurrent or sequential chemoradiotherapy in

September 2021. The product has the potential to become an anti-PD-L1

monoclonal antibody approved to cover stage III and stage IV NSCLC in all-comer

settings.

About Cejemly(R) (sugemalimab)

The potential best-in-class anti-PD-L1 monoclonal antibody Cejemly(R)

(sugemalimab) is an investigational anti-PD-L1 monoclonal antibody discovered

by CStone. Authorized by the U.S.-based Ligand Corporation, Cejemly(R) is

developed by 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, Cejemly(R) mirrors the natural G-type immunoglobulin 4

(IgG4) human antibody, which reduces the risk of immunogenicity and potential

toxicities in patients, a unique advantage over similar drugs.

Currently, the China NMPA has approved the potential best-in-class anti-PD-L1

monoclonal antibody Cejemly(R) in combination with chemotherapy for the

treatment of treatment-naïve patients with stage IV NSCLC. In addition,

Cejemly(R) is being investigated in a number of ongoing clinical trials,

including one Phase II registrational study for lymphoma and four Phase III

registrational studies in stage III NSCLC, stage IV NSCLC, gastric cancer, and

esophageal cancer, respectively.

CStone formed a strategic collaboration agreement with Pfizer that includes the

development and commercialization of Cejemly(R) in mainland China, and a

framework to bring additional oncology assets to the Greater China market.

About the GEMSTONE-302 Study

The GEMSTONE-302 study (ClinicalTrials.gov registration number: NCT03789604;

drug clinical trial registration number: CTR20181452) is a randomized,

double-blind Phase III study, designed to evaluate the efficacy and safety of

anti-PD-L1 monoclonal antibody Cejemly(R) combined with chemotherapy as the

first-line treatment in treatment-naïve patients with stage IV NSCLC vs.

placebo combined with chemotherapy. The primary endpoint of the study was

investigator-assessed PFS. Secondary endpoints included OS, BICR-assessed PFS

and safety, etc.

In August 2020, the GEMSTONE-302 study met its primary endpoint of

significantly prolonged PFS, with the risk of disease progression or death

reduced by 50% with Cejemly(R) combined with chemotherapy compared to placebo

combined with chemotherapy, as assessed by iDMC at the planned interim

analysis. Specific study data were presented in a Proffered Paper Oral

Presentation (Late-Breaking Abstract) at the ESMO Asia 2020.

In July 2021, the final analysis of PFS from the GEMSTONE-302 study showed that

Cejemly(R) in combination with chemotherapy demonstrated further improvement in

PFS and the risk of disease progression or death was reduced by 52%, together

with a trend of OS benefits. Data were presented in a Mini Oral Presentation

(Late-Breaking Abstract) at the IASLC 2021 World Conference on Lung Cancer.

About CStone

CStone is a biopharmaceutical company focused on researching, developing, and

commercializing innovative immuno-oncology and precision medicines to address

the unmet medical needs of cancer patients in China and worldwide. Established

in 2015, CStone has assembled a world-class management team with extensive

experience in innovative drug development, clinical research, and

commercialization. The Company has built an oncology-focused pipeline of 15

drug candidates with a strategic emphasis on immuno-oncology combination

therapies. Currently, CStone has received four drug approvals in Greater China,

including three in Mainland China and one in Taiwan. CStone's vision is to

become globally recognized as a world-renowned biopharmaceutical company by

bringing innovative oncology therapies to cancer patients worldwide.

For more information about CStone, please visit: www.cstonepharma.com.

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, Pfizer applies science and our global resources to bring therapies

to people that extend and significantly improve their lives. Pfizer strives to

set the standard for quality, safety and value in the discovery, development

and manufacture of health care products, including innovative medicines and

vaccines. Every day, Pfizer colleagues work across developed and emerging

markets to advance wellness, prevention, treatments and cures that challenge

the most feared diseases of our time. Consistent with our responsibility as one

of the world's premier innovative biopharmaceutical companies, Pfizer

collaborates with health care providers, governments and local communities to

support and expand access to reliable, affordable health care around the world.

For more than 170 years, Pfizer has worked to make a difference for all who

rely on Pfizer.

For more information about Pifzer, please visit www.pfizer.com.cn.

Cautionary Statement required by Rule 18A.05 of the Listing Rules: THE COMPANY

CANNOT GUARANTEE THAT WE MAY BE ABLE TO ULTIMATELY DEVELOP AND MARKET

CEJEMLY(R) (SUGEMALIMAB) SUCCESSFULLY. Shareholders of the Company and

potential investors are advised to exercise due care when dealing in the shares

of the Company

Source: CStone Pharmaceuticals