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 accepted for review the
supplemental new drug application (sNDA) for toripalimab (trade
name: TUOYI®, product code: JS001) combined with bevacizumab for
the first-line treatment of unresectable or metastatic
hepatocellular carcinoma (HCC).
Liver cancer is a
common malignant tumor of the digestive system worldwide, and the
predominant pathological type is HCC (accounting for about 90% of
global cases). According to the 2022 GLOBOCAN Report, there were
866,000 new cases and 759,000 deaths from liver cancer globally
that year. China is particularly affected by liver cancer, with new
liver cancer cases reaching 368,000 (accounting for 42.4% of global
cases) in 2022, ranking fourth in new cases among domestic
malignant tumors, and the number of deaths reaching 317,000
(accounting for 41.7% of global cases), ranking second among
domestic malignant tumors. Due to its insidious onset, about
70%-80% of liver cancer patients in China are already at the
intermediate or advanced stage upon first diagnosis, with a median
OS of approximately only 10 months and a 5-year survival rate of
approximately 12%. In recent years, the continuous emergence of
combination therapies based on immunotherapy drugs has transformed
the treatment landscape of advanced liver cancer, and achieving a
radical cure after downstaging is gradually becoming a
possibility.
The sNDA is based on
the HEPATORCH study (NCT04723004), a multicenter, randomized,
open-label, active-controlled phase III clinical study aiming to
evaluate the efficacy and safety of toripalimab in combination with
bevacizumab for the first-line treatment of unresectable or
metastatic HCC compared to the standard treatment with sorafenib.
Conducted across 57 centers nationwide in China, HEPATORCH was led
by Principal Investigator Professor Jia FAN, President of Zhongshan
Hospital affiliated to Fudan University and academician of the
Chinese Academy of Sciences.
In June 2024, the
primary endpoints of progression-free survival (PFS, based on
independent radiological review) and overall survival (OS) of the
HEPATORCH study met the pre-defined efficacy boundary. The results
of the study showed that toripalimab in combination with
bevacizumab for the first-line treatment of patients with advanced
HCC could significantly prolong the PFS and OS of the patients
compared with sorafenib, while improving the secondary endpoints
such as objective response rate and time to progression. The safety
profile of toripalimab was consistent with the known risks, and no
new safety signals were identified. Further details will be
presented at a future international academic conference.
Principal investigator
Professor Jia FAN, Academician of Chinese Academy of Sciences and
President of Zhongshan Hospital, said, “Due to the hidden onset of
HCC, most domestic patients have already missed the opportunity for
radical surgery at the time of initial diagnosis. The HEPATORCH
study results show that first-line treatment of advanced HCC with
toripalimab combined with bevacizumab offers significant survival
benefits. The study also reaffirms the efficacy of combining
immunosuppressants with anti-angiogenesis targeting drugs for
advanced HCC. We eagerly await the approval of this therapy that
combines toripalimab with bevacizumab, which will provide new
treatment options for advanced HCC patients in China!”
“I’m delighted to see
the successful submission of the sNDA for toripalimab’s 11th
indication,” General Manager and CEO of Junshi Biosciences, Dr.
Jianjun ZOU, said. “Since receiving marketing approval in 2018 as
the first domestically developed anti-PD-1 monoclonal antibody,
toripalimab has targeted the unmet needs of cancer patients in
China and even internationally. As of now, it has been approved for
10 indications in 7 cancer types, many of which are exclusive
indications. This sNDA is toripalimab’s first indication in liver
cancer, and once again, toripalimab is demonstrating its
‘broad-spectrum’ when battling cancer. Going forward, we will
actively communicate with regulatory authorities to speed up the
approval of this indication, so that more advanced liver cancer
patients can benefit from our innovative therapy.”
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 eight 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
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