Junshi Biosciences Announces NDA Acceptance in Hong Kong for
Toripalimab
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, announced that the Drug
Office, Department of Health, the Government of the Hong Kong
Special Administrative Region (“DO”) has recently accepted the New
Drug Application (“NDA”) for toripalimab in combination with
cisplatin and gemcitabine for the first-line treatment of adults
with metastatic or recurrent locally advanced nasopharyngeal
carcinoma (“NPC”), and as a single agent for the treatment of
adults with recurrent, unresectable, or metastatic NPC with disease
progression on or after platinum-containing chemotherapy.
The NDA is supported by results from JUPITER-02, a randomized,
double-blind, placebo-controlled, multinational multi-center Phase
3 clinical study (NCT03581786) that examined toripalimab in
combination with gemcitabine-cisplatin as the first-line treatment
of NPC, as well as results from POLARIS-02, a multi-center,
open-label, pivotal Phase 2 clinical study (NCT02915432) that
evaluated toripalimab as the second-line or later treatment for
recurrent or metastatic NPC.
Results from JUPITER-02, the first international, multi-center,
double-blind, randomized, placebo-controlled Phase 3 clinical study
using immunotherapy for the treatment of NPC with the largest
sample size, were presented at the plenary session of the 2021
American Society of Clinical Oncology (ASCO) annual meeting
(#LBA2), and published in Nature Medicine and the Journal of the
American Medical Association (JAMA). The study found that compared
to chemotherapy alone, toripalimab in combination with chemotherapy
for the first-line treatment of metastatic or recurrent NPC
significantly improved progression-free survival (“PFS”) and
overall survival (“OS”), with a median PFS of 21.4 months and a
3-year OS rate of 64.5%. Toripalimab plus chemotherapy also reduced
the risk of disease progression or death by 48% and the risk of
death by 37%, all while demonstrating a manageable safety
profile.
The POLARIS-02 results were published online in January 2021 in
the Journal of Clinical Oncology. These findings showed that
toripalimab demonstrated durable antitumor activity in patients
with recurrent or metastatic NPC who failed previous chemotherapy,
with an objective response rate (ORR) of 20.5%, a median duration
of response (DoR) of 12.8 months, and a median OS of 17.4 months
while maintaining a manageable safety profile.
So far, toripalimab has been approved for marketing in the
Chinese mainland and the US. Several NDAs are currently under
regulatory review in the European Union, UK, Australia, Singapore,
Malaysia and Hong Kong Special Administrative Region (“SAR”).
Furthermore, NDAs for toripalimab have also been submitted in
India, South Africa, Chile and Jordan.
About NPC
NPC is a malignant tumor that occurs in the nasopharyngeal
mucosal epithelium and is one of the most common types of head and
neck cancer. According to the World Health Organization, 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, while radiotherapy alone or in combination with
chemotherapy are the main treatment options for localized
cancers.
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 China, toripalimab was the first domestic anti-PD-1
monoclonal antibody approved for marketing (approved in China as
TUOYI®). Currently, there are eight approved indications for
toripalimab in the Chinese mainland:
- unresectable or metastatic melanoma after failure of standard
systemic therapy;
- recurrent or metastatic 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).
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 Hong Kong 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 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 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, marketing authorization applications (MAA) were
accepted by the European Medicines Agency (EMA) and the MHRA for 1)
toripalimab combined with cisplatin and gemcitabine for the
first-line treatment of patients with locally recurrent or
metastatic NPC and 2) toripalimab combined with paclitaxel and
cisplatin for the first-line treatment of patients with
unresectable locally advanced/recurrent or metastatic ESCC, in
December 2022 and February 2023.
In Australia, Singapore and Hong Kong SAR, NDAs were accepted by
the Australia Therapeutic Goods Administration (TGA), the Singapore
Health Sciences Authority (HSA) and DO for toripalimab, both in
combination with cisplatin and gemcitabine for the first-line
treatment of adults with metastatic or recurrent locally advanced
NPC, and as a single agent for the treatment of adults with
recurrent, unresectable, or metastatic NPC with disease progression
on or after platinum-containing chemotherapy. Toripalimab obtained
an Orphan Drug designation from the TGA and a Priority Review
designation from the HSA.
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 3,000 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
Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800
PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86
021-6105 8800