Junshi Bio Tumor Immunity Summit Forum & Tuoyi? The National Marketing Conference for Lung Cancer Indications was successfully held

Shanghai, September 30, 2022 /PRNewswire/ -- On September 30, 2022, the Junshi Bio Tumor Immunization Summit Forum and the National Listing Meeting of Tuoyi ^® (Terreprimumab Injection) Lung Cancer Indications were successfully held
in an online format.
The conference brought together Chinese and foreign lung cancer scholars and gathered the frontier progress of global lung cancer, and specially invited Academician Yu Jinming of Shandong Provincial Cancer Hospital, Professor Cheng Ying of Jilin Provincial Cancer Hospital, Professor Lu Shun of Chest Hospital Affiliated to Shanghai Jiao Tong University, Professor Wang Jie of Cancer Hospital of Chinese Academy of Medical Sciences, and Professor Wang Changli of Cancer Hospital of Tianjin Medical University Professor Wu Yilong of Guangdong Provincial People's Hospital, Professor Zhou Caicun of Shanghai Pulmonary Hospital affiliated to Tongji University, and Professor Zhang Li of the Cancer Prevention and Control Center of Sun Yat-sen University formed the presidium of the conference, and was composed of Professor Fan Yun of the Affiliated Cancer Hospital of the University of Chinese Academy of Sciences, Professor Song Yong of the Jinling Hospital Affiliated to the School of Medicine of Nanjing University, and the People's Liberation Army Professor Wang Baocheng of 960 Hospital served as the moderator of the conference, and Professor Zhu Bo of Chongqing Xinqiao Hospital and Professor Roy S.
Herbst of Yale Cancer Center attended
the conference as speakers.
About 39,000 guests gathered in the clouds for the event
.

Lung cancer is currently the second most common and most mortality malignant tumor in the world[^1], and also ranks first in incidence and mortality in China^[2].

According to data released by the World Health Organization, the number of lung cancer cases in China accounted for 17.
9% (816,000) of new cancer cases and 23.
8% (715,000) of cancer deaths in ^2020[2].

In September 2022, the anti-PD-1 monoclonal antibody drug Tuoyi ^® (terreprimab) independently developed by Junshi Biologics, the "forerunner" of Chinese biomedical innovation, combined with pemetrexed and platinum-based suitable for epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative, New indications for first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that cannot be surgically removed are approved by
the National Drug Administration (NMPA).
As a broad-spectrum anti-cancer drug, this is the sixth indication approved for terreprimumab in China, successfully expanding the treatment field from melanoma, nasopharyngeal cancer, urothelial carcinoma and esophageal cancer to lung cancer
.

Academician Yu Jinming, chairman of the conference, congratulated Tuoyi ^® (teriprizumab) on obtaining a new indication for lung cancer, "With the rapid development of tumor immunotherapy, immunotherapy has become more and more important
in the practice of lung cancer treatment.
Let us work together with China's original research pharmaceutical companies represented by Junshi Bio to jointly promote the development of lung cancer diagnosis and treatment in China, and bring new vitality and new hope
to the majority of lung cancer patients.
"

THE BETTER CHOICE: Bringing "Beneficial Choices" to Lung Cancer Patients

Topixumab ^® lung cancer indications were approved primarily based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial CHOICE-01 study (NCT03856411) that included 465 untreated patients with
advanced NSCLC.

Professor Wang Jie, the principal investigator of CHOICE-01, made a wonderful interpretation
of the experimental data at the meeting.
"Immunocombination therapy has become the standard first-line treatment for advanced driver gene-negative NSCLC, and clinicians are often confused by 'The CHOICEs We can Make'
in the face of many treatment options," she said.

The results of the CHOICE-01 study showed that patients with advanced NSCLC without EGFR/ALK mutation who received first-line therapy with terreprimumab plus chemotherapy had significant progression-free survival (PFS) and overall survival (OS) benefits compared with chemotherapy alone, and the efficacy was not affected by PD-L1 expression; Among them, the benefits of PFS and OS in patients with non-squamous cell carcinoma are particularly prominent, the efficacy is no less than that of imported similar drugs, the risk of progression and death can be reduced by 52%, and the 2-year OS rate is as high as 62.
6%.

In addition, to analyze the correlation between genomic changes and survival benefits, CHOICE-01 is the only large phase III study of its kind in lung cancer that uses whole exome sequencing (WES
).
The WES results showed that patients with mutations in the FA-PI3K-Akt, IL-7, SWI/SNF pathway had a
significant benefit from the combination chemotherapy regimen of terreprimumab compared with chemotherapy alone.
We look forward to CHOICE-01 leading the way in precision treatment and helping clinicians make 'THE BETTER CHOICE'!" "

Brainstorming: "United, precise, and perioperative" opens a new journey of lung cancer immunotherapy

Based on data and based on clinical practice, many experts and scholars in the field of lung cancer discussed the progress of lung cancer research and development and new treatment strategies at the meeting, and comprehensively interpreted the hot topics
of immunotherapy in the field of lung cancer.

Professor Zhou Caicun shared his thoughts on the new strategy of immunotherapy NSCLC, he said: "Immunotherapy has become an important treatment method for early, medium and late NSCLC, and new preparations of immunotherapy combination are also a hot spot of clinical concern, and various new preparations such as immunotherapy drugs combined with anti-angiogenic agents, LAG3, TIGIT, CD73 and co-stimulating molecules have shown positive efficacy
。 Immunotherapy is known as the hope of conquering cancer, whether it is a new immune preparation or a cancer vaccine, it is only the tip of the immunological iceberg, looking forward to more breakthroughs in immunotherapy and bringing more miracles to cancer patients! "

Professor Zhu Bo introduced the current situation of biomarkers in immunotherapy for lung cancer, and focused on five major development directions in the future, including: 1) the application of multiple biomarker combinations; 2) Biomarker exploration of artificial intelligence applied to immunotherapy; 3) Fine clustering of immune cell subsets; 4) on-treatment biomarkers; 5) New biotechnology facilitates immunotherapy biomarker discovery
.

Professor Lu Shun shared his progress and thinking on perioperative NSCLC immunotherapy, he said: "For neoadjuvant immunotherapy, from the biomarkers, the impact on surgery, the beneficiary population, and the efficacy indicators, the preliminary results show that the Asian population and the IIIA stage benefit more in neoadjuvant immunotherapy, and the PD-L1 expression is a relatively clear biomarker, which does not increase the difficulty of surgery and does not affect surgery.
Simultaneous display of the correlation between MPR and pCR and EFS; For adjuvant immunotherapy, the benefits from biomarkers, beneficiary populations, and safety were discussed, and the benefits of non-squamous cell carcinoma were more, the biomarker was not clear, the efficacy of different PD-L1 expression patients was inconsistent, ctDNA was a potential biomarker, and the follow-up perioperative immunotherapy research results
were expected.
In the future, perioperative NSCLC immunotherapy will be more MDT-based and biomarker-based treatment models
.
"

According to Professor Lu Shun, the ongoing NEOTORCH study (terreprimumab combined chemotherapy) is the first phase III study of perioperative NSCLC immunotherapy in Chinese population, and is expected to be completed by the end of 2022, and terreprimumab is expected to open a new model
of perioperative immunotherapy.

Professor Roy S.
Herbst, who shared the new global trend of NSCLC immunotherapy, said: "In the future, the direction of immunotherapy exploration may focus more on individualized therapy
.
We need to do more research in biomarkers, combination therapies
.
At the same time, we also need to do more innovative research design and broader cooperation to obtain more adequate scientific data
.
The future of immunotherapy has arrived! "

Complement each other: Diverse tumor pipelines continue to improve patient survival

At present, Junshi Bio's R&D pipeline has more than 50 drug candidates, including terreprimumab, about 75% of which are oncology products
.
It is worth noting that nearly 1/3 of the products are not targeting tumor cells, but targeting immune cells (often T cells), immune microenvironment (such as targeting microvascular vessels, increasing microvascular circulation, lymphocyte infiltration), etc.
, in order to solve the "three major problems" faced by tumor immunotherapy by exploring the combination of various mechanisms, and continuously expand the beneficiary population
.

Dr.
Jianjun Zou, President of Global R&D of Junshi Biologics, said: "Based on the company's long-term accumulation in the field of tumor immunotherapy (I-O), we have established a differentiated tumor pipeline
with terreprimumab as the 'cornerstone' in response to the three major problems of 'PD-1 post-treatment drug resistance', 'cold tumor' and 'lack of tumor-specific T cells at source' 。 Among them, in the field of lung cancer, we are exploring triplizumab, tifcemalimab (anti-BTLA monoclonal antibody), JS006 (anti-TIGIT monoclonal antibody), JS007 (anti-CTLA-4 monoclonal antibody), JS009 (anti-CD112R monoclonal antibody), JS014 (IL-21 fusion protein), JS111 (EGFR exon 20 insertion and other uncommon mutation inhibitors), JS112 (Aurora A inhibitor), The efficacy of single-drug/combination therapy in different subtypes and different stages of treatment of products such as JS113 (4th generation EGFR inhibitor) hopes to continue to bring better treatment options to patients! "

Mr.
Li Cong, Co-CEO of Junshi Biologics, said: "As an innovative biopharmaceutical company, Junshi Biologics has always taken solving the unmet needs of clinical patients as its forward mission, focusing on the research and development
of first-in-class or best-in-class drugs.
Lung cancer is the malignant tumor with the highest incidence and mortality rate in China, we will work with clinical experts to develop more and better products to jointly help the survival of lung cancer patients in China! "

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

2.
If you would like to know the diagnosis and treatment information of specific diseases, please follow the advice and guidance
of medical and health professionals.

【References】

[1] https://gco.
iarc.
fr/today/data/factsheets/cancers/15-Lung-fact-sheet.
pdf 
[2] https://gco.
iarc.
fr/today/data/factsheets/populations/160-china-fact-sheets.
pdf 

About terreprimumab injection (Tuoyi ^®).

As the first domestic monoclonal antibody drug with PD-1 as the target approved for listing in China, Triprimumab Injection (Tuoyi ^®) has been supported by major national science and technology projects and won the highest award in the field of national patents, "China Patent Gold Award"
.

To date, terreprimumab has conducted more than 30 company-initiated clinical studies
covering more than 15 indications around the world, including in China, the United States, Southeast Asia and Europe.
Ongoing or completed key registered clinical studies evaluating the safety and efficacy of terreprimumab across multiple tumor species, including lung, nasopharyngeal, esophageal, stomach, bladder, breast, liver, kidney, and skin
cancers.

To date, terreprimab has been approved for 6 indications in China: for the treatment of unresectable or metastatic melanoma that has failed to undergo systemic therapy in the past (December 2018); For the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who have previously failed second-line and above systematic therapy (February 2021); for the treatment of locally advanced or metastatic urothelial carcinoma that fails to contain platinum-containing chemotherapy including progression within 12 months of neoadjuvant or adjuvant chemotherapy (April 2021); Combined cisplatin and gemcitabine for first-line treatment in patients with locally recurrent or metastatic nasopharyngeal carcinoma (November 2021); Combined with paclitaxel and cisplatin, for first-line treatment in patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (May 2022); Combined with pemetrexed and platinum for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer with negative epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) negative, non-surgically resectable (September 2022
).
In December 2020, terreprimumab passed the national medical insurance negotiations for the first time, and 3 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, terreprimumab has been awarded 2 breakthrough therapeutic designations, 1 fast-track designation, 1 priority review certification and 5 orphan drug qualification designations by the FDA in the fields of mucosal melanoma, nasopharyngeal cancer, soft tissue sarcoma, esophageal cancer and small cell lung cancer, and has been granted orphan drug qualification by
the European Commission in the field of nasopharyngeal cancer 。 In July 2022, the FDA accepted a resubmitted application for a bioproduct license (BLA) for terriprimab combined with gemcitabine/cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal cancer and as a single drug for second-line and above treatment of recurrent or metastatic nasopharyngeal cancer after platinum-containing therapy, with a target review date set for December 23, 2022
.

About Junshi Biology

Junshi Biologics (688180.
SH, 1877.
HK) was founded in December 2012 as 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 research, covering five major therapeutic areas, including malignant tumors, autoimmune system diseases, chronic metabolic diseases, nervous system diseases and infectious diseases
.

With the core platform technology of protein engineering, Junshi Bio is at the forefront of international macromolecular drug research and development, and has obtained the first domestic anti-PD-1 monoclonal antibody NMPA listing approval, domestic anti-PCSK9 monoclonal antibody NMPA clinical application approval, the world's first therapeutic tumor anti-BTLA blocking antibody in China NMPA and the US FDA clinical application approval, and is currently carrying out a number of Phase I/II clinical trials
in China and the United States.

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

At present, Junshi Bio has more than 3,100 employees around the world, distributed in San Francisco and Maryland, Shanghai, Suzhou, Beijing, Guangzhou and so on
.

Official website: www.
junshipharma.
com

Official WeChat: Junshi Bio