- HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal
antibody (mAb) approved for first-line treatment of ES-SCLC
- HETRONIFLY® (serplulimab) is expected to become the first
anti-PD-1 monoclonal antibody available in Europe for first-line treatment of
ES-SCLC
AHMEDABAD, India, Sept. 21,
2024 /PRNewswire/ -- Intas Pharmaceuticals
Limited ("Intas") has announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has issued a positive opinion recommending
approval of HETRONIFLY® (serplulimab, approved as Hansizhuang
in China), in European
markets.
Serplulimab, a recombinant humanised anti-PD-1 monoclonal
antibody (mAb) injection, is the first innovative monoclonal
antibody developed by Henlius. It has been granted orphan drug
status designation by the U.S. Food and Drug Administration (FDA)
and the European Commission (EC) for the treatment of Small Cell
Lung Cancer (SCLC).
Serplulimab will be commercialised by Intas through its
subsidiary, Accord Healthcare Ltd (Accord), across more than 30
countries in Europe. As one of the
key players in the global oncology market, Accord has a
longstanding commitment to oncology with proven commercial
capabilities and currently supplies around one in three injectable
oncology medicines in Europe. This
positive opinion from CHMP marks another step closer for both
Henlius and Intas to provide serplulimab for patients in
Europe.
Dr. Jason Zhu, Executive
Director and Chief Executive Officer of Henlius, stated:
"The positive opinion from CHMP signifies a major milestone in
our efforts to accelerate the global reach of our products, and
further validates Henlius' patient-centred R&D approach and
commitment to global strategy. We look forward to the formal
approval of this treatment in Europe, bringing more treatment options and
hope to patients there and worldwide."
Paul Tredwell, Executive
Vice President of EMENA at Accord, said "I am
thrilled with the CHMP's positive opinion. This not only
strengthens our current partnership with Henlius but also means
serplulimab is on track to become part of the treatment landscape
for extensive stage small cell lung cancer patients who currently
have limited options and face a poor prognosis."
Alex Falgas, Senior Vice
President of Business Development at Accord said "The
CHMP's positive opinion on serplulimab is a pivotal moment in our
mission to provide world-class cancer treatments to patients in
Europe. This strengthens our
oncology portfolio and reinforces Accord's commitment to
alleviating the global cancer burden, ensuring greater access to
innovative therapies for those in need."
According to GLOBOCAN 2022, lung cancer is the most diagnosed
and the first mortality cancer around the world. There were more
than 2.48 million new cases of lung cancer worldwide in 2022,
accounting for 12.4% of all new cancer cases. [1] Small
cell lung cancer (SCLC) accounts for 15%–20% of the total number of
lung cancer cases, and is associated with early metastasis, rapid
disease progression, and an extremely poor prognosis.
The positive opinion from CHMP is primarily based on ASTRUM-005,
a randomized, double-blind, placebo-controlled international
multi-centre clinical study, which evaluated the efficacy and
adverse event profile of the PD-1 inhibitor serplulimab plus
chemotherapy compared with placebo plus chemotherapy as first-line
treatment in patients with ES-SCLC.
References:
[1] Bray F, Laversanne M, Sung H, et al. Global cancer
statistics 2022: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries. CA Cancer J
Clin. 2024;74(3):229-263. doi:10.3322/caac.21834
About Henlius
Henlius (2696.HK) is a global
biopharmaceutical company with the vision to offer high-quality,
affordable, and innovative biologic medicines for patients
worldwide with a focus on oncology, autoimmune diseases, and
ophthalmic diseases. Up to date, 6 products have been launched in
China, 3 have been approved for
marketing in overseas markets, 24 indications are approved
worldwide, and 3 marketing applications have been accepted for
review in China and the EU,
respectively. Since its inception in 2010, Henlius has built an
integrated biopharmaceutical platform with core capabilities of
high-efficiency and innovation embedded throughout the whole
product life cycle including R&D, manufacturing and
commercialization. It has established global innovation centre and
Shanghai-based commercial
manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has pro-actively built a diversified and high-quality
product pipeline covering over 50 molecules and has continued to
explore immuno-oncology combination therapies with proprietary
HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched
products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU
(trastuzumab, trade name: HERCESSI™ in the U.S.,
Zercepac® in Europe), a China-developed mAb biosimilar approved in
China, Europe and U.S., HANDAYUAN (adalimumab),
HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative
product HANSIZHUANG has been approved by the NMPA for the treatment
of MSI-H solid tumours, squamous non-small cell lung cancer
(sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and
esophageal squamous cell carcinoma (ESCC), making it the world's
first anti-PD-1 mAb for the first-line treatment of SCLC. What's
more, Henlius has conducted over 30 clinical studies for 16
products, expanding its presence in major markets as well as
emerging markets.
About Intas
Intas is one of the leading multinational
pharmaceutical formulation development, manufacturing, and
marketing companies in the world. The company has set up a network
of subsidiaries under the name Accord for marketing and selling in
the highly regulated markets of EU, US, Canada, South
Africa, Australia,
Asia Pacific, CIS and MENA
regions. Intas is present in 85+ countries worldwide with more than
69% of its revenue coming from global business, particularly the
highly regulated markets of the EU and the US.
Currently ranked 6th (As per IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical
market, it is also the largest privately owned Indian generic
pharmaceutical company. While Intas has established leadership in
key therapeutic segments like CNS, Cardiovascular, Diabetology,
Plasma Therapy, Cell and Gene Therapy, Gastroenterology, Urology
and Oncology in India, the company
is known for its range of products in Oncology and other
hospital-based therapeutic segments in the EU and US.
Intas' success and growth are a direct influence of Intas'
extensive R&D and manufacturing capabilities. Intas operates
sixteen formulation manufacturing facilities, of which eleven are
in India, and the rest in the
U.K., Greece, and Mexico. Between them, the facilities are
accredited by top global regulators such as the US FDA, EMA, MHRA,
TGA, and others. Every year, the company invests 6-7% of its
revenues in R&D. Currently; Intas has over 10,000 product
registrations worldwide and a strategic pipeline of 300+ high-value
FTF/FTM, Biosimilars and NDDS products.
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