Stock code: 688180 Stock abbreviation: Junshi Biological Announcement No.: Pro 2023-026.

SHANGHAI JUNSHI BIOMEDICAL TECHNOLOGY CO., LTD

Voluntary disclosure on the use of treprozumab in patients with operable non-small cell lung cancer

Announcement on Acceptance of Application for Marketing of New Indications for Perioperative Treatment

The board of directors and all directors of the company guarantee that there are no false records or misleading statements in the contents of this announcement.

or major omissions, and shall bear legal responsibility for the authenticity, accuracy and completeness of its contents in accordance with the law.

Recently, Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as the "Company") received a national

The Drug Administration approved the issuance of the "Notice of Acceptance", Treplimab (trade name: Tuoyi?,

Product code: JS001) combined with chemotherapy perioperative treatment and this product as a single drug as an adjuvant treatment after consolidation treatment,

New indications for the treatment of resectable stage III non-small cell lung cancer are accepted. Because of drugs

The development cycle is long, the approval process is many, vulnerable to some uncertainties, this new indication.

There is uncertainty about whether the listing application can be approved. Please be cautious in making decisions and pay attention to preventing investment

Risk. The relevant information is hereby announced as follows:

Basic information of 1. drugs

Drug Name: Triplimab Injection

Application: Domestic production of drug registration and marketing license

acceptance number: CXSS2300017, CXSS2300018

Applicant: Shanghai Junshi Biomedical Technology Co., Ltd.

Approval conclusion: According to the provisions of Article 32 of the the People's Republic of China Administrative License Law, after examination,

Decided to be admissible.

Other information related to 2. drugs

Lung cancer is the second most common malignant tumor in the world. According to the World Health Organization

The number of new lung cancer cases in China in 2020 was 816000, accounting for the number of new cancer cases in China.

17.9 percent, the number of lung cancer deaths in China in 2020 was 715000, accounting for 23.8 percent of cancer deaths in China.

Non-small cell lung cancer is the main subtype of lung cancer, accounting for about 85% of all cases. Of these, 20-25% of patients

Newly diagnosed patients can be surgically resected, but even after radical surgery, 30%-55% of patients will relapse and die after surgery. Radical surgery combined with chemotherapy is one of the means to prevent disease recurrence, but the clinical benefit of chemotherapy as preoperative neoadjuvant or postoperative adjuvant therapy is limited, which can only improve the 5-year survival rate of patients by about 5%.

This new indication listing application is based on the Neotorch study (NCT04158440), which is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study, with Professor Lu Shun from the Chest Hospital of Shanghai Jiaotong University School of Medicine as the principal investigator. The study started in 56 centers across the country. Patients with operable non-small cell lung cancer received neoadjuvant and adjuvant therapy with teripilimumab/placebo combined with platinum-containing dual-drug chemotherapy, and after completing postoperative adjuvant therapy, they received teripilimumab/placebo single-drug consolidation therapy. The platinum-containing dual-drug chemotherapy regimen was selected by the researchers according to the institutional diagnosis and treatment routine. Patients with squamous cell carcinoma were treated with taxanes and platinum, non-squamous cell carcinoma patients were treated with pemetrexed combined with platinum. In January 2023, the Independent Data Monitoring Committee (IDMC) determined at the time of the interim analysis that the primary study endpoint event-free survival (hereinafter referred to as "EFS") of the Neotorch study reached the pre-defined advantage margin of the protocol. Neotorch became the world's first non-small in operable

Phase III registry studies demonstrating that perioperative anti-PD-1 monoclonal antibody significantly prolongs EFS in patients with cellular lung cancer

Investigate. The results of the interim analysis showed that, compared with chemotherapy alone, the peri-operative treatment of patients with stage III operable non-small cell lung cancer and the subsequent consolidation of the monotherapy of the monotherapy of

Significantly prolonged EFS in patients. Detailed data will be available on April 20, 2023 at 3 pm EDT.

The American Society of Clinical Oncology General Assembly Series (ASCO PlenarySeries) will be the first global announcement in the form of an oral presentation.

Treprolizumab injection is the first domestic monoclonal antibody drug with PD-1 as the target approved for marketing in China. It has won the highest national patent award "China Patent Gold Award". So far, it has carried out more than 40 clinical studies initiated by the company covering more than 15 indications in the world (including China, the United States, Southeast Asia and Europe). Ongoing or completed pivotal registry clinical studies evaluate the safety and efficacy of teripilimumab in a wide range of tumors, including lung cancer, nasopharyngeal cancer, esophageal cancer, gastric cancer, bladder cancer, breast cancer, liver cancer, kidney cancer and skin cancer. As of the disclosure date of this announcement, the six indications of Treplimab have been approved in China. In December 2020, Treplimab injections passed the national health insurance negotiations for the first time, and three indications are now included in the national health insurance catalogue (2022 edition), which is the only anti-PD-1 monoclonal antibody drug in the national health insurance catalogue for the treatment of melanoma.

In terms of international layout, as of the disclosure date of this announcement, Treplimab has been in mucosal melanoma,

In the field of nasopharyngeal carcinoma, soft tissue sarcoma, esophageal cancer and small cell lung cancer, the U.S. Food and Drug Administration (hereinafter referred to as "FDA") has granted 2 breakthrough therapy recognition, 1 fast track recognition, 1 priority review recognition and 5 orphan drug qualification recognition. At present, the biologics license application (BLA) of treprozumab combined with gemcitabine/cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and single drug for second-line and above treatment after platinum-containing therapy for recurrent or metastatic nasopharyngeal carcinoma is under FDA review. 2022

In December and February 2023, the company submitted to the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Administration.

The applications for marketing authorizations (MAAs) submitted by the Bureau (MHRA) of teripilimumab in combination with cisplatin and gemcitabine for first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma and paclitaxel and cisplatin for first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma were respectively accepted.

3. Risk Alert

Due to the high-tech, high-risk and high-value-added characteristics of pharmaceutical products, the early research and development of drugs and the long cycle and many links from development, clinical trial approval to production of products are easily affected by some uncertain factors. There is uncertainty about whether the application for listing of new indications can be approved. Please the majority of investors cautious decision-making, pay attention to prevent investment risk.

The company will actively promote the above research and development projects, and in strict accordance with the relevant provisions of the follow-up progress of the project to fulfill the obligation of information disclosure. The relevant company information shall be subject to the announcements published in the company's designated disclosure media "China Securities Journal", "Shanghai Securities News", "Securities Times", "Securities Daily" and the website of the Shanghai Stock Exchange.

It is hereby announced.

SHANGHAI JUNSHI BIOMEDICAL TECHNOLOGY CO., LTD

Board of Directors

April 12, 2023