Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX:
1877; SSE: 688180), a leading innovation-driven biopharmaceutical
company dedicated to the discovery, development, and
commercialization of novel therapies, and its wholly-owned
subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences),
announce that the European Commission (EC) has approved toripalimab
(European trade name: LOQTORZI®) for the treatment of two
indications:
- Toripalimab in combination with
cisplatin and gemcitabine for the first-line treatment of adult
patients with recurrent, not amenable to surgery or radiotherapy,
or metastatic nasopharyngeal carcinoma (NPC);
- Toripalimab in combination with
cisplatin and paclitaxel for the first-line treatment of adult
patients with unresectable advanced, recurrent, or metastatic
oesophageal squamous cell carcinoma (ESCC).
In July, a positive opinion was issued
by the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) for the marketing authorization
application (MAA) of these two indications. This approval applies
to all 27 member states of the European Union, Iceland, Norway and
Liechtenstein, making toripalimab the first and only drug in Europe
for the treatment of NPC and the only first-line treatment for
advanced or metastatic ESCC, regardless of PD-L1 status.
NPC is a malignant tumor that occurs
in the nasopharyngeal mucosal epithelium and is one of the most
common types of head and neck cancers globally. According to
GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases
in 2022 exceeded 120,000 worldwide. Due to the location of the
primary tumor, surgery is rarely an option. The latest European
Society of Medical Oncology (ESMO) Guidelines recommend
immunotherapy combined with chemotherapy as the first-line
treatment for recurrent or metastatic NPC.
The approval of the NPC indication is
primarily based on the results from the JUPITER-02 study (a
randomized, double-blind, placebo-controlled, multinational
multi-center Phase III clinical study, NCT03581786). The JUPITER-02
study is the first international multi-center, double-blind,
randomized Phase III clinical study in the field of immunotherapy
for NPC with the largest sample size, and the world’s first Phase
III clinical study with preset statistical verification (Type I
error control) for Overall Survival (“OS”) for first-line
immunotherapy combined with chemotherapy for NPC compared to
chemotherapy alone and demonstrated a survival benefit. The study
results were presented in an oral report during the Plenary Session
of the 2021 annual meeting of the American Society of Clinical
Oncology (ASCO) (#LBA2) and were subsequently featured on the cover
of Nature Medicine. The results were also published in full in the
Journal of the American Medical Association (JAMA). The results
showed that, compared to chemotherapy alone, toripalimab in
combination with chemotherapy reduced the risk of disease
progression by 48% and the risk of death by 37%. The median
progression-free survival (“PFS”) in the toripalimab plus
chemotherapy group was prolonged by 13.2 months compared to
chemotherapy alone, from 8.2 months to 21.4 months. In addition,
patients treated with this combined therapy achieved a higher
objective response rate (ORR), longer duration of response (DoR),
and higher disease control rate (DCR), and no new safety signal was
identified. Long-term survival follow-up data, presented at ASCO
2024, reported a 5-year survival rate of 52.0%.
EC is one of the most common malignant
tumors in the alimentary tract. According to GLOBOCAN 2022
statistics, esophageal cancer is the 11th most commonly diagnosed
cancer and the seventh leading cause of cancer death worldwide,
with over 511,000 new cases and over 445,000 deaths in 2022. ESCC
and esophageal adenocarcinoma are the two main histological
subtypes of esophageal cancer. The ESMO Guidelines recommend PD-1
blocking antibodies combined with chemotherapy for the treatment of
patients with advanced or metastatic ESCC with PD-L1 positive
status.
The approval of the ESCC indication is
primarily based on the results from the JUPITER-06 study (a
randomized, double-blind, placebo-controlled, multi-center Phase
III clinical study, NCT03829969). The study aimed to evaluate the
efficacy and safety of toripalimab in combination with
paclitaxel/cisplatin (TP) for the first-line treatment of advanced
ESCC compared with placebo in combination with chemotherapy. The
results were first presented in an oral session during the ESMO
Congress 2021 and later published in Cancer Cell and Journal of
Clinical Oncology, two leading international oncology journals. The
results of the study showed that toripalimab in combination with
chemotherapy resulted in superior PFS and OS in patients with
advanced or metastatic ESCC, the median OS was prolonged by 6
months to 17 months and the risk of disease progression or death in
patients was significantly reduced by 42%. Futhermore, there was
significant improvement in survival benefits regardless of PD-L1
status.
Professor Ruihua XU, Principal
Investigator and President of Sun Yat-sen University Cancer Center,
said, “Both NPC and EC are highly prevalent in Asia, while the
development of innovative therapies for these cancer types has been
slow in Europe and the Americas. The outstanding results from the
JUPITER-02 and JUPITER-06 studies reflect the pioneering leadership
of Chinese researchers in the diagnosis, treatment, and clinical
research of NPC and EC. We hope that this ‘Chinese Solution’ will
truly transform the outlook for patients around the world who have
long lacked effective treatment options for these cancers, and
bring them renewed hope for survival!”
Dr. Jianjun ZOU, General Manager and
CEO of Junshi Biosciences, said, “‘In China, For Global’ has been a
core strategic goal of Junshi Biosciences since its inception. The
approval of toripalimab by the EC signifies that, following our
success in China and the US, our global commercial strategy has
officially expanded into Europe. It also reflects the international
recognition of our research and production quality for innovative
drugs. Moving forward, we will continue to collaborate with our
partners on the commercialization of toripalimab in Europe, and
provide high-quality, innovative therapies from China to more
patients worldwide.”
Dr. Patricia Keegan, Chief Medical
Officer of TopAlliance Biosciences, said, “Junshi Biosciences and
TopAlliance Biosciences are dedicated to producing innovative
therapies that offer survival benefits to patients around the world
while consistently addressing the clinical needs of local
populations. This approval represents another significant milestone
in our entry into the global market. In addition to toripalimab, we
have several promising indications and drugs under development
internationally. We believe that our commitment to providing
patients with more effective treatment options will continually
motivate us toward becoming a leading international innovative
enterprise.”
About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for
its ability to block PD-1 interactions with its ligands, PD-L1 and
PD-L2, and for enhanced receptor internalization (endocytosis
function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes
the immune system’s ability to attack and kill tumor cells.
More than forty company-sponsored toripalimab clinical studies
covering more than fifteen indications have been conducted globally
by Junshi Biosciences, including in China, the United States,
Southeast Asia, and Europe. Ongoing or completed pivotal clinical
trials evaluating the safety and efficacy of toripalimab cover a
broad range of tumor types, including cancers of the lung,
nasopharynx, esophagus, stomach, bladder, breast, liver, kidney,
and skin.
In the Chinese mainland, toripalimab was the first domestic
anti-PD-1 monoclonal antibody approved for marketing (approved in
China as TUOYI®). Currently, there are ten approved indications for
toripalimab in the Chinese mainland:
- unresectable or metastatic melanoma
after failure of standard systemic therapy;
- recurrent or metastatic nasopharyngeal
carcinoma (NPC) after failure of at least two lines of prior
systemic therapy;
- locally advanced or metastatic
urothelial carcinoma that failed platinum-containing chemotherapy
or progressed within 12 months of neoadjuvant or adjuvant
platinum-containing chemotherapy;
- in combination with cisplatin and
gemcitabine as the first-line treatment for patients with locally
recurrent or metastatic NPC;
- in combination with paclitaxel and
cisplatin in first-line treatment of patients with unresectable
locally advanced/recurrent or distant metastatic esophageal
squamous cell carcinoma (ESCC);
- in combination with pemetrexed and
platinum as the first-line treatment in EGFR mutation-negative and
ALK mutation-negative, unresectable, locally advanced or metastatic
non-squamous non-small cell lung cancer (NSCLC);
- in combination with chemotherapy as
perioperative treatment and subsequently with monotherapy as
adjuvant therapy for the treatment of adult patients with
resectable stage IIIA-IIIB NSCLC;
- in combination with axitinib for the
first-line treatment of patients with medium to high risk
unresectable or metastatic renal cell carcinoma (RCC);
- in combination with etoposide plus
platinum for the first-line treatment of extensive-stage small cell
lung cancer (ES-SCLC);
- in combination with paclitaxel for
injection (albumin-bound) for the first-line treatment of recurrent
or metastatic triple-negative breast cancer (TNBC).
The first six indications have been included in the National
Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the
only anti-PD-1 monoclonal antibody included in the NRDL for the
treatment of melanoma. In April 2024, the Drug Office at the
Department of Health in the Government of the Hong Kong Special
Administration Region (DO) accepted the NDA for toripalimab in
combination with cisplatin and gemcitabine for the first-line
treatment of adults with metastatic or recurrent locally advanced
NPC, and for toripalimab, as a single agent, for the treatment of
adults with recurrent, unresectable, or metastatic NPC with disease
progression on or after platinum-containing chemotherapy.
In the United States, the US Food and Drug Administration (FDA)
has approved the Biologics License Application for toripalimab in
combination with cisplatin and gemcitabine for the first-line
treatment of adults with metastatic or recurrent locally advanced
NPC, and for toripalimab, as a single agent, for the treatment of
adults with recurrent, unresectable, or metastatic NPC with disease
progression on or after platinum-containing chemotherapy in October
2023. The FDA has granted toripalimab 2 Breakthrough Therapy
designations for the treatment of NPC, 1 Fast Track designation for
the treatment of mucosal melanoma, and 5 Orphan Drug designations
for the treatment of esophageal cancer, NPC, mucosal melanoma, soft
tissue sarcoma, and small cell lung cancer (SCLC).
In Europe, the EC approved marketing authorization applications
(MAA) for toripalimab 1) combined with cisplatin and gemcitabine
for the first-line treatment of patients with locally recurrent or
metastatic NPC and 2) combined with paclitaxel and cisplatin for
the first-line treatment of patients with unresectable locally
advanced/recurrent or metastatic ESCC in September 2024. The UK
Medicines and Healthcare products Regulatory Agency (MHRA) accepted
the MAA in February 2023.
In Australia, the new chemical entity (NCE) application was
accepted by the Australia Therapeutic Goods Administration (TGA) in
November 2023. The TGA has also granted toripalimab an Orphan Drug
designation for the treatment of NPC.
In Singapore, the NDA application was accepted by the Singapore
Health Sciences Authority (HSA) in January 2024. The HSA has also
granted priority review designation for the NDA.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE:
688180) is an innovation-driven biopharmaceutical company dedicated
to the discovery, development and commercialization of innovative
therapeutics. The company has established a diversified R&D
pipeline comprising over 50 drug candidates, with five therapeutic
focus areas covering cancer, autoimmune, metabolic, neurological,
and infectious diseases. Four of the company’s innovations have
already reached the Chinese or international markets, one of which
is toripalimab, China’s first domestically produced and
independently developed anti-PD-1 monoclonal antibody, approved in
China and the US. Additionally, more than 30 drugs are currently in
clinical development. During the COVID-19 pandemic, Junshi
Biosciences actively shouldered the social responsibilities of a
Chinese pharmaceutical company through its involvement in
developing etesevimab, MINDEWEI®, and other novel therapies for the
prevention and treatment of COVID-19.
With a mission of “providing patients with world-class,
trustworthy, affordable, and innovative drugs,” Junshi Biosciences
is “In China, For Global.” At present, the company boasts
approximately 2,500 employees in the United States (San Francisco
and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou,
etc.). For more information, please visit:
http://junshipharma.com.
Junshi Biosciences Contact InformationIR
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021-6105 8800