Junshi Biosciences Announces Approval of the sNDA for Toripalimab
for the 1st-Line Treatment of Advanced TNBC
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 National
Medical Products Administration (NMPA) has approved the
supplemental new drug application (sNDA) for toripalimab (product
code: JS001) in combination with paclitaxel for injection
(albumin-bound) for the first-line treatment of recurrent or
metastatic triple-negative breast cancer (TNBC).
According to the GLOBOCAN 2020
statistics, breast cancer became the most common cancer in the
world, with 2.31 million new cases and 0.67 million deaths. In
China, there were 0.36 million new cases and 0.07 million deaths
due to breast cancer, accounting for 15.5% and 11.2% of global
cases. Amongst these, TNBC accounts for about 10% to 15% of all
breast cancer cases, making TNBC a more aggressive type of cancer
with a higher risk of recurrence and poor prognosis. Advanced TNBC
is not responsive to targeted or endocrine therapies and lacks
specific treatment methods. Chemotherapy remains the standard
treatment for advanced TNBC in China, but both mono-chemotherapy
and combined chemotherapy have poor efficacy, with a median
survival time of about 9 to 12 months and a 5-year survival rate of
less than 30%.
The supplemental NDA approval is based
on the TORCHLIGHT study (NCT04085276), a randomized, double-blind,
placebo-controlled, multi-center Phase III clinical study jointly
conducted in 56 centers across the country. Professor Zefei JIANG,
Vice President and Secretary General of the Chinese Society of
Clinical Oncology (CSCO) and from the Department of Oncology of the
Chinese People’s Liberation Army General Hospital, served as the
principal investigator.
In February 2023, the Independent Data
Monitoring Committee (IDMC) determined in an interim analysis that
the primary endpoint of the TORCHLIGHT study had met the
pre-defined efficacy boundary. TORCHLIGHT is the first registered
domestic Phase III study to achieve positive results in the field
of advanced TNBC immunotherapy.
In January 2024, Nature Medicine
(Impact Factor: 58.7) published the interim results of the
TORCHLIGHT study. The findings showed that, compared with
paclitaxel alone, toripalimab in combination with paclitaxel in
patients with an initial diagnosis of stage IV or recurrent
metastatic TNBC can significantly prolong the progression-free
survival (PFS) of PD-L1-positive patients. The overall survival
(OS) also showed a positive trend, achieving a breakthrough in
immunotherapy for advanced TNBC in China. The median PFS in the
toripalimab group was 8.4 months, and the risk of disease
progression or death was reduced by 35% (P=0.0102). The median OS
in the toripalimab group was extended by 13.3 months (32.8 months
vs 19.5 months), and the risk of death was reduced by 38%
(P=0.0148). The safety profile of toripalimab remained consistent
with the established safety profile, with no new safety signals
identified.
“Immunotherapy has become the most
important treatment for TNBC,” said Principal investigator
Professor Zefei JIANG from the Department of Oncology of the
Chinese People’s Liberation Army General Hospital. “The TORCHLIGHT
study introduces immune checkpoint inhibitors in addition to
traditional chemotherapy, which not only significantly prolongs the
mPFS for patients with advanced TNBC, but also demonstrates notable
benefits to overall survival, increasing the total survival time
for TNBC patients to more than 30 months. As the very first
approved immunotherapy for TNBC in China, toripalimab will set a
new standard for the first-line treatment of TNBC.”
“For a long time, effective treatments
for advanced TNBC have been lacking,” said Dr. Jianjun ZOU, General
Manager and CEO of Junshi Biosciences. “The approval of this new
indication is another milestone success, and it offers new hope to
Chinese patients with advanced TNBC. As of now, toripalimab has 10
approved indications in China. Moving forward, we will remain
dedicated to patient care, collaborate with Chinese experts and
scholars, and address the long-standing unmet clinical needs of
many more patients.”
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 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, 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 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