- Sugemalimab becomes the world's first anti-PD-L1 monoclonal
antibody (mAb) approved in Europe
for first-line treatment of both squamous and non-squamous
non-small cell lung cancer (NSCLC), also marking the first
successful international approval of a China domestic anti-PD-L1 mAb.
- The European Commission (EC) approval is based on the results
of GEMSTONE-302 Phase 3 trial, which demonstrated that sugemalimab
in combination with chemotherapy significantly prolonged
progression-free survival and overall survival in treatment-naive
patients with metastatic NSCLC.
- CStone has entered into a strategic commercialization
partnership with Ewopharma for sugemalimab in Central &
Eastern Europe and Switzerland.
- Discussions for commercial partnerships in including
Western Europe, Latin America, the Middle East, Southeast Asia, etc., are progressing well and
are expected to conclude soon.
- CStone is actively preparing to submit additional Marketing
Authorization Applications (MAAs) to the European Medicines Agency
(EMA) for new indications, including Stage III NSCLC, first-line
Gastric Cancer, first-line Esophageal Cancer, and
relapsed/refractory extranodal natural killer/T-cell lymphoma (r/r
ENKTL).
SUZHOU, China, July 26, 2024 /PRNewswire/ -- CStone
Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven
biopharmaceutical company focused on the research and development
of anti-cancer therapies, today announced that the European
Commission (EC) has approved sugemalimab (Brand name:
Cejemly®) in combination with platinum-based
chemotherapy is indicated for the first-line treatment of adults
with metastatic non-small-cell lung cancer (NSCLC) with no
sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumour
aberrations. Sugemalimab has become the first anti-PD-L1 monoclonal
antibody (mAb) approved in Europe
in combination with chemotherapy as first-line treatment for both
squamous and non-squamous NSCLC, making CStone the first innovative
biopharmaceutical company to successfully bring a China domestic anti-PD-L1 mAb to the
international market.
The EC approval is primarily based on the results of the
GEMSTONE-302, a multicenter, randomized, double-blind phase 3
study. The study demonstrated that sugemalimab in combination with
chemotherapy significantly prolonged progression-free survival and
overall survival compared to placebo combined with chemotherapy in
treatment-naïve patients with metastatic NSCLC. The study results
have been published in The Lancet Oncology and Nature
Cancer, and have been presented at multiple international
academic conferences. Additionally, long-term treatment and
survival data from the GEMSTONE-302 study will be presented in a
poster session (#1318P) at the 2024 ESMO Annual Meeting.
Dr. Jason Yang, CEO, President of
R&D and Executive Director of the Board at CStone, said, "We
are extremely excited by today's announcement, which represents a
major milestone in CStone's journey towards becoming a leading
global company dedicated to eradicating cancer. Sugemalimab has not
only become CStone's first independently-developed product to
receive overseas marketing authorization but it is also the world's
first anti-PD-L1 mAb to receive regulatory approval in Europe in combination with chemotherapy as
first-line treatment for both squamous and non-squamous NSCLC. This
achievement reflects the international regulatory authorities'
recognition of our high-quality R&D and manufacturing
standards, and it infuses new momentum into our globalization
strategy. We are humbled by level of interest in sugemalimab
commercial partnership from companies around the world which only
signifies the large unmet need in this class for newer and better
drugs. We are actively engaging with potential partners in
Western Europe, Latin America, the Middle East and Africa, Southeast
Asia, and Canada and we
expect to announce the completion of these deals soon."
Dr. Yang recalled, "In early May
2023, CStone regained the development and commercialization
rights for sugemalimab outside Greater
China. Since then, the entire company acted swiftly, with
all departments working in coordination to thoroughly review
regulatory and submission documents, assess their completeness,
perform gap analyses, screened and replaced numerous suppliers, and
completed the applicant transfer and submission dossier updates.
Within just over a month of fully taking over the MAA, the EMA
issued a critical Day 120 List containing 194 outstanding
questions. After analyzing a vast amount of data, our team
submitted a detailed response to the EMA within the required
timeframe. By Day 180, nearly 90% of the responses issues has
accepted by EMA's Reviewers resolved, and the remaining ones were
further clarified and eventually agreed by the EMA. During the
review period, we also successfully passed the EMA's routine GMP
inspection of the manufacturing plant, and GCP inspections of two
study centers and a CRO, which lasted a total of three weeks.
Subsequently, at the end of May this year, we received a positive
opinion from the EMA's Committee for Medicinal Products for Human
Use (CHMP) recommending approval of sugemalimab. I truly believe
that this journey, marked by numerous challenges, reflects the
CStone team's resilience and innovative spirit."
Dr. Jason Yang emphasized, "The
international approval and commercialization of sugemalimab mark a
significant milestone in CStone's Pipeline 1.0 strategy,
demonstrating our success in developing best-in-class
immuno-oncology drugs for monotherapy and as a foundation for
combination therapies. In Pipeline 2.0, we have global rights for a
range of highly promising candidates, either in international
multicenter clinical trials or approaching the clinical stage, with
the potential to be first-in-class or best-in-class. Additionally,
we are actively exploring the combination of sugemalimab with other
treatment modalities, such as antibody-drug conjugates (ADCs) and
bi-/tri-specific antibodies, to enhance its clinical value as a
backbone of cancer immunotherapy."
Dr. Yang added, "The seven-year journey of sugemalimab to
becoming a first-line treatment for NSCLC in Europe and other cancers in China is a testament to the extensive
expertise of numerous Chinese oncology specialists. It also
reflects the dedication of patients who participated in sugemalimab
clinical trials and the relentless efforts of our R&D team over
the years. The remarkable results of the GEMSTONE-302 study provide
definitive scientific evidence supporting the use of sugemalimab in
combination with chemotherapy as a first-line standard therapy for
Stage IV NSCLC. We are honored and humbled that this 'Chinese
innovative solution' may significantly improve outcomes for lung
cancer patients worldwide, offering both longer survival and a
better quality of life."
Meanwhile, CStone is actively preparing to submit multiple
Marketing Authorization Applications (MAAs) for additional
indications, including Stage III NSCLC, first-line Gastric Cancer,
first-line Esophageal Cancer, and relapsed/refractory extranodal
natural killer/T-cell lymphoma (r/r ENKTL).
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content:https://www.prnewswire.co.uk/news-releases/cstone-announces-european-commission-approval-of-sugemalimab-cejemly-as-first-line-treatment-for-non-small-cell-lung-cancer-302207524.html