Junshi Biologics announced that it has submitted a marketing authorization application for teripulimab to the UK Medicines and Healthcare Products Administration

• This is the second marketing application for teripulimab in Europe, and its global commercialization is progressing steadily

SHANGHAI, Nov.
24, 2022 /PRNewswire/ -- November 24, 2022, Beijing time, Junshi Biologics (1877.
HK,688180 .
SH) announced that the company has recently submitted a marketing authorization application
for the anti-PD-1 monoclonal antibody drug teripulimab to the UK Medicines and Healthcare Products Agency (MHRA).
The indications declared this time are: 1) teripulimab combined with cisplatin and gemcitabine for first-line treatment in patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC); 2) Teripulimab in combination with paclitaxel and cisplatin for first-line treatment
in patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Previously, Junshi Biologics has submitted marketing authorization applications
for these two indications to the European Medicines Agency (EMA).

Dr.
Patricia Keegan, Chief Medical Officer of Junshi Biologics, said, "This month, we submitted our marketing applications for teripulimab to two major European regulatory agencies, which reflects the company's strong determination and efficient execution to promote innovative drugs for the benefit of patients around the world
.
In the future, we will work closely with the UK regulator to actively promote the clinical development and application
of emerging therapies in the region.
"

The NPC and ESCC indications are based on the findings
of JUPITER-02 (a randomized, double-blind, placebo-controlled, international multicenter phase III clinical study, NCT03581786) and JUPITER-06 (a randomized, double-blind, placebo-controlled, multicenter phase III study NCT03829969), respectively.

The JUPITER-02 results were first presented at the plenary meeting of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (#LBA2) and subsequently published
as the cover article of the September 2021 issue of Nature Medicine (impact factor: 87.
241).
。 The results showed that for patients with relapsed or metastatic NPC who had not received systemic therapy, the median progression-free survival (PFS) in the teripulimab plus chemotherapy group was significantly longer than that in the placebo plus chemotherapy group, 21.
4 vs.
8.
2 months, 13.
2 months, and that teripulimab plus chemotherapy reduced the risk of disease progression or death by 48% (HR = 0.
52, 95% CI: 0.
37 to 0.
73, bilateral p<0.
0001)
。

At present, two indications of teripulimab for first-line and late-line treatment of advanced NPC have been approved in China, and it is the world's first immune checkpoint inhibitor (ICI)
approved for treatment in this field.
Internationally, the NPC indication of teripulimab has been granted 2 breakthrough therapy designations and 2 orphan drug designations by US and EU regulatory authorities
.
The Biologics License Application (BLA) for teripulimab in the United States is under review and is expected to be the first and only drug
used in the treatment of nasopharyngeal carcinoma in the country.

The JUPITER-06 results were presented orally at the annual meeting of the European Society of Medical Oncology (ESMO 2021) and subsequently presented
in Cancer Cell (impact factor: 38.
585), a leading international oncology journal 。 The results showed that for patients with advanced or metastatic ESCC who did not undergo systemic chemotherapy, teripulimab combined with chemotherapy resulted in better survival benefits for more patients than chemotherapy alone, with median overall survival (OS) significantly extended to 17 months, compared with control chemotherapy alone for 6 months, and the risk of disease progression or death was reduced by 42% (HR=0.
58, P<0.
0001), regardless of PD-L1 expression<b11>.
Based on the above research, the first-line indication of teripulimab for the treatment of advanced ESCC was approved
in China.
In addition, the use of teripulimab for the treatment of esophageal cancer has also been granted orphan drug designation by the US regulatory body
.

--Finish--

1.
This material is intended to convey cutting-edge information, is not intended to promote any products to you, and is not intended as a clinical medication guide
.

2.
If you want to know the diagnosis and treatment of specific diseases, please follow the advice and guidance
of medical and healthcare professionals.

About nasopharyngeal carcinoma

Nasopharyngeal carcinoma is a malignant tumor that originates in the mucosal epithelium of the nasopharynx and is one of
the common head and neck tumors.
According to the World Health Organization, the number of new cases of nasopharyngeal carcinoma worldwide exceeded 130,000 in 2020 ^[1].

Due to the location of the primary tumor, surgery is rarely used, and patients with local disease are mainly treated
with chemotherapy and radiotherapy.
In the US and Europe, there are currently no drugs approved for the first-line standard therapy (gemcitabine/cisplatin) for the treatment of nasopharyngeal carcinoma, recurrent or metastatic nasopharyngeal carcinoma, based on randomized studies
conducted in China.

【References】

[1] https://gco.
iarc.
fr/today/data/factsheets/cancers/4-Nasopharynx-fact-sheet.
pdf.

About esophageal cancer

Esophageal cancer is one of the most common malignant tumors in the
digestive tract.
According to statistics, esophageal cancer is the seventh most common malignant tumor and the sixth leading cause of cancer death in the world in 2020, with more than 600,000 new cases and more than 540,000 deaths ^[1].

Esophageal squamous cell carcinoma (ESCC) and adenocarcinoma are the two main histological subtypes
of esophageal cancer.
Newly updated ESMO guidelines recommend platinum and fluorouracil dual agents in combination with PD-1 blocking antibodies for the treatment of locally advanced or metastatic ESCC ^[2].

It is worth noting that the immunotherapy indications that have been approved for treatment in this field in Europe and the United States are only applicable to some people
with ESCC.
Therefore, new drugs and treatment regimens are urgently needed to prolong survival in patients with ESCC, especially those with
low PD-L1 expression.

【References】

[1] https://gco.
iarc.
fr/today/data/factsheets/cancers/6-Oesophagus-fact-sheet.
pdf.

[2] Obermannova R,Alsina M, Cervantes A,Leong T,Lordick F, Nilsson M,van Greeken NCT, Vogel A,Smyth EC; ESMO Guidelines Committee.
ESMO Clinical Practice Guidline for diagnosis,treatment and follow-up.
Ann Oncol.
2022 Oct; 33(10):992-1004

About teripulimab injection (Tuoyi ^®).

As the first domestic monoclonal antibody drug targeting PD-1 approved for marketing in China, teripulimab injection (Tuoyi ^®) has been supported by major national science and technology projects, and won the highest national patent award "China Patent Gold Award"
.

To date, more than 30 company-initiated clinical studies
covering more than 15 indications have been carried out in teripulimab around the world (including China, the United States, Southeast Asia and Europe).
Key regulatory clinical studies underway or completed evaluate the safety and efficacy of teripulimab in multiple tumor types, including lung, nasopharyngeal, esophageal, gastric, bladder, breast, liver, kidney and skin
cancers.

Up to now, teripulimab has been approved for 6 indications in China: for the treatment of unresectable or metastatic melanoma that has previously failed systemic therapy (December 2018); For the treatment of patients with relapsed/metastatic nasopharyngeal carcinoma who have previously failed second-line or above systemic therapy (February 2021); for the treatment of locally advanced or metastatic urothelial carcinoma in which platinum-containing chemotherapy fails including progression within 12 months of neoadjuvant or adjuvant chemotherapy (April 2021); combination cisplatin and gemcitabine for first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (November 2021); Combination of paclitaxel and cisplatin for first-line treatment in patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (May 2022); Combination of pemetrexed and platinum for first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer with mutation-negative epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK)-negative, unresectable (September 2022).

In December 2020, teripulimab passed the national medical insurance negotiation for the first time, and three indications have been included in the 2021 Drug List, which is the only anti-PD-1 monoclonal antibody drug
used in the national medical insurance list for the treatment of melanoma and nasopharyngeal cancer.

In terms of international layout, teripulimab has been granted 2 breakthrough therapy designations, 1 fast-track designation, 1 priority review designation and 5 orphan drug designation by the US Food and Drug Administration (FDA) in the fields of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, esophageal cancer and small cell lung cancer
, and orphan drug designation by the European Commission.

In July 2022, FDA accepted the resubmitted Biologics License Application (BLA) for teripulimab in combination with gemcitabine/cisplatin as first-line therapy and monotherapy for second-line and above treatment following platinum-containing therapy for relapsed or metastatic nasopharyngeal carcinoma in patients with advanced relapsed or metastatic nasopharyngeal carcinoma, with a target review date of December 23
, 2022 。 In November 2022, Junshi Biologics submitted a marketing authorization application (MAA) for teripulimab in combination with cisplatin and gemcitabine for the first-line treatment of patients with locally relapsed or metastatic nasopharyngeal carcinoma and with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/relapsed or metastatic esophageal squamous cell carcinoma to the European Medicines Agency (EMA)
and the UK Medicines and Healthcare Products Agency (MHRA), respectively.

About Junshi Biologics

Junshi Biotechnology(688180.
Founded in December 2012, SH,1877.
HK) is an innovation-driven biopharmaceutical company
dedicated to the discovery, development and commercialization of innovative therapies.
The company has a rich R&D pipeline consisting of more than 50 products under development, covering five major therapeutic areas, including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurological diseases and infectious diseases
.

With the core platform technology of protein engineering, Junshi Biologics is at the forefront of international macromolecule drug research and development, and has obtained the first domestic anti-PD-1 monoclonal antibody NMPA marketing approval, domestic anti-PCSK9 monoclonal antibody NMPA clinical application approval, the world's first anti-BTLA blocking antibody for the treatment of tumors in NMPA in China and the US FDA, and is currently carrying out a number of phase Ib/II clinical trials
in China and the United States.

Since the beginning of the outbreak in 2020, Junshi Biologics has responded quickly, joined hands with domestic and foreign scientific research institutions and enterprises to fight the epidemic, and used technology accumulation to quickly develop a variety of innovative drugs for the treatment of COVID-19, actively assuming the social responsibility
of Chinese pharmaceutical enterprises 。 These include: the first new coronavirus neutralizing antibody in China to enter the clinical stage and participate in the global anti-epidemic novel coronavirus neutralizing antibody etesivimab (JS016) obtained emergency use authorization in more than 15 countries and regions in 2021, the new oral nucleoside anti-new coronavirus drug VV116 (JT001) has entered the international multi-center phase III registration clinical research stage, and other types of drugs, continuing to contribute to the global fight against the epidemic
.

At present, Junshi Biologics has more than 3,100 employees worldwide, located in San Francisco and Maryland, Shanghai, Suzhou, Beijing and Guangzhou, China
.

Official website: www.
junshipharma.
com

Official WeChat: Junshi Biotechnology