Junshi Biosciences: Junshi Biosciences voluntarily disclosed the announcement on the signing of a distribution and commercialization agreement with Leo Pharmaceuticals
DATE:  Jan 21 2025

Securities code: 688180 Securities abbreviation: Junshi Biosciences Announcement No.: Pro 2025-006

Shanghai Junshi Biomedical Technology Co., Ltd

Voluntary Disclosure in relation to the signing of the agreement with Leo Pharma

Announcement of Distribution and Commercialization Agreement

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.

Important Content Notes:

Recently, Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as the "Company") is wholly owned

TopAllianceBiosciences Inc. ("TopAlliance") and LEOPharmaA/S ("Leo") have entered into a Distribution and Commercialization Agreement (the "Agreement"). Under this agreement, Topailay will grant Leo the exclusive right to store, distribute, promote, market and sell toripalimab in all current member states and any future member states of the European Union (EU) and the European Economic Area (EEA), as well as Switzerland and the United Kingdom (the "Partnership Regions").

This transaction does not constitute a connected transaction, nor does it constitute the Administrative Measures for the Material Asset Restructuring of Listed Companies

Provision for material asset restructuring.

There are no major legal obstacles to the implementation of this transaction.

The payment agreed in this agreement needs to meet certain preconditions, and the final payment amount is correct

The impact of the Company's future operating income and profit is uncertain. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

1. Transaction Overview

Recently, TopScope Airlay signed a Distribution and Commercialization Agreement with Leo Pharmaceuticals. Under the terms of this agreement, TopEl will grant Leo the exclusive right to store, distribute, promote, market and sell toripalimab in the Cooperative Territory.

In accordance with the Rules for the Listing of Stocks on the Science and Technology Innovation Board of the Shanghai Stock Exchange and the Articles of Association of Shanghai Junshi Biomedical Technology Co., Ltd., the transaction does not need to be submitted to the board of directors and the general meeting of shareholders of the company for deliberation.

This transaction does not constitute a connected transaction, nor does it constitute a material asset restructuring as stipulated in the Administrative Measures for Material Asset Restructuring of Listed Companies.

2. The subject matter of this agreement

Toripalimab Injection is the first domestic monoclonal antibody drug targeting PD-1 approved for marketing in China, and has won the "China Patent Gold Award", the highest award in the field of national patents, and has carried out more than 40 clinical studies initiated by the company covering more than 15 indications around the world (including China, the United States, Europe and Southeast Asia). Ongoing or completed pivotal registrational clinical studies evaluating the safety and efficacy of toripalimab across multiple tumor types. As of the disclosure date of this announcement, toripalimab has been approved for marketing in Chinese mainland, Hong Kong, the United States, the European Union, India, the United Kingdom, Jordan, Australia and other countries and regions. Toripalimab was approved by the European Commission (EC) and the UK Medicines and Healthcare products Agency (MHRA) for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, inoperable or radiotherapy, or metastatic nasopharyngeal carcinoma, and toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced/recurrent or metastatic esophageal squamous cell carcinoma.

3. Basic information of the counterparty

Leo Pharmaceuticals is a global company dedicated to improving the standard of care for patients with skin diseases through innovation, while also providing anticoagulant therapy to cancer patients and other specialty patients. Leo Pharmaceuticals is owned by the major shareholder Leoki

It is co-owned with Nordic Capital since 2021. Leo Pharmaceuticals offers a wide range of therapeutic properties

, serving 100 million patients worldwide every year. Leo Pharmaceuticals is headquartered in Denmark and employs 4,000 people worldwide.

According to Leo Pharmaceuticals' 2023 Annual Report, as of December 31, 2023, Leo Pharmaceutical's total assets and:

Net assets amounted to EUR 2,811 million and EUR 607 million, respectively. In 2023, Leo Pharmaceuticals achieved revenue of 1.529 billion

EUR and net loss of EUR 484 million.

Leo Pharma is not affiliated with the Company or Topai Lay. In addition to this transaction, there is no other relationship between Leo Pharma and the Company and Topai in terms of property rights, business, assets, creditor's rights and debts, personnel, etc.

Fourth, the main content of the agreement

(1) The content of cooperation

Top-Aire will grant Leo the exclusive right to store, distribute, promote, market and sell toripalimab in the Cooperative Territory. Subject to the specific conditions set forth in the agreement, Leo Pharma may sublicense to

Third party.

(2) Financial terms

1. Down payment: Leo Pharma will make an upfront payment of €15 million to Topai Air. Exclusive rights will not be effective until the down payment is made in full.

2. Milestones: If the two parties wish to cooperate on the subsequent approved indications of toripalimab in the cooperation region, the two parties shall agree on any milestone payments to Toppleel.

3. Sales share: Leo Pharma will pay a double-digit percentage of the net sales of toripalimab in the cooperative area to Top-Air.

(3) The term of the agreement

This Agreement shall be effective from the date of execution of the Agreement and shall be valid for twelve years unless terminated earlier in accordance with the provisions of this Agreement. Thereafter, this Agreement will be automatically extended for another year, unless either party terminates this Agreement in writing to the other party in writing six months prior to the end of the Initial Term or the end of any subsequent one-year period, in whole or in part. Except as otherwise expressly provided in this Agreement, neither party may terminate this Agreement prior to the foregoing date.

(4) Applicable Law

This Agreement is governed by the laws of England and Wales.

5. The impact of this transaction on the company

This cooperation is an important practice for the company to practice the internationalization strategy of "based in China and deployed globally", and it is also an important step for Topus Airlay to develop its business layout in the European market. With the help of Leo's mature drug distribution network and rich marketing experience in the European market, toripalimab will accurately and efficiently cover patients in the cooperative regions, greatly shorten the market introduction cycle, and provide high-quality treatment options for patients in Europe. The transaction will also enhance the global brand influence of the product and the company, and further expand the layout of the company's global commercialization network. The transaction is expected to have a positive impact on the Company's continuing operations.

6. Risk Warning

Due to the high-tech, high-risk, and high value-added characteristics of pharmaceutical products, and the commercialization of drugs may be affected by local policies, changes in the market environment and other factors, there is some uncertainty about whether toripalimab can be successfully commercialized in the cooperation area and the actual sales. In addition, the payment agreed in this agreement is subject to certain preconditions, and the final payment amount and the impact on the company's future operating income and profit are uncertain. Therefore, investors are advised to make prudent decisions and pay attention to preventing investment risks.

The company will actively promote the above projects, and in strict accordance with the relevant regulations to fulfill the information disclosure obligations on the follow-up progress of the project in a timely manner. The relevant company information is subject to the announcements published on the company's designated disclosure media, "China Securities Journal", "Shanghai Securities News", "Securities Times" and the website of the Shanghai Stock Exchange.

The announcement is hereby made.

Shanghai Junshi Biomedical Technology Co., Ltd

board of directors

January 21, 2025

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