Junshi Biosciences: Announcement on the signing of a license and cooperation agreement between a holding subsidiary and JSMA Biosciences
DATE:  Sep 27 2024

Securities code: 688180 Securities abbreviation: Junshi Biosciences Announcement No.: Pro 2024-059

Shanghai Junshi Biomedical Technology Co., Ltd

Signed a contract with JSEM on the holding subsidiary

Announcement of Licensing and Cooperation Agreements

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:

On September 26, 2024, Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as "Public")

Shanghai Juntuo Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as "Juntuo Bio"), a holding subsidiary of the company, and Nanjing Jisheng Oma Biopharmaceutical Co., Ltd. (hereinafter referred to as "Jisheng Oma") signed the IAMA-001 Nasal Spray Project License and Cooperation Agreement (hereinafter referred to as the "License and Cooperation Agreement" or "Agreement"). Pursuant to the license and cooperation agreement, JSEM granted Juntuo the exclusive license right to develop, improve, manufacture, produce, use, declare, register, commercialize and otherwise exploit IAMA-001 small nucleic acid immunomodulator nasal spray drug (hereinafter referred to as the "Licensed Product") in Greater China (including Chinese mainland, Hong Kong SAR, Macau S.A.R. and Taiwan) based on the licensed intellectual property rights, and cooperated with Juntuo Biologics to develop IAMA-001 outside of Greater China Nasal spray type items. Juntuo Biotech will pay the corresponding down payment, milestone payment and sales commission to JSEM according to the progress of the project.

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.

The transaction has been deliberated and approved by the third meeting of the fourth board of directors of the company, and does not need to be submitted to the general meeting of shareholders of the company for deliberation.

There is a risk to whether the final licensed product can be successfully approved for marketing. In addition, the payment of milestone payments and sales commissions agreed in the licensing and cooperation agreements is subject to certain conditions, and the final payment amount is uncertain. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

1. Transaction Overview

On September 26, 2024, the company's holding subsidiary, Juntuo Biotech, signed a license and cooperation agreement with JSEM

Agreement. Pursuant to the license and cooperation agreement, JSMA granted Juntuo the exclusive license right to develop, improve, manufacture, produce, use, declare, register, commercialize and exploit the licensed product in any other way based on the licensed intellectual property rights in Greater China, and cooperated with Juntuo Biologics to develop the IAMA-001 nasal spray form project outside Greater China. Juntuo Biotech will pay the corresponding down payment, milestone payment and sales commission to JSEM according to the progress of the project.

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.

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 has been deliberated and approved by the third meeting of the fourth board of directors of the company, and does not need to be submitted to the general meeting of shareholders of the company for deliberation.

Second, the basic situation of the counterparty

Company name: Nanjing Jisheng Oma Biopharmaceutical Co., Ltd

Nature of enterprise: limited liability company (foreign investment, non-sole proprietorship)

Unified social credit code: 91320191MA261XDUXN

LEGAL REPRESENTATIVE: LIU LIMING

Founded: May 17, 2021

Registered capital: 6,828,706 yuan

Registered address: No. 3-1 Xinjinhu Road, Jiangbei New District, Nanjing, Sino-Danish Ecological Life Science Industrial Park II

Phase E, 3rd Floor, Building E

JSMA is a clinical-stage biopharmaceutical company focused on immunotherapy for respiratory diseases. Through a differentiated drug development pathway, JSMA has successfully established a series of drug discovery platforms from which it has obtained a number of drug candidates with global intellectual property rights and broad clinical uses. The core team of JSEMA comes from a world-renowned biopharmaceutical company, and has established a variety of innovative drug R&D platforms including nucleic acid drug R&D, respiratory preparations and delivery, and innate immune antibody R&D, with a total of 6 pipelines. Since JSM is a non-listed company, its main financial data for the most recent year is considered by it to be a trade secret and therefore cannot be provided.

The Company and its holding subsidiary, Juntuo Biopharma, have no affiliation with JSM, nor do they have any other relationships in terms of property rights, business, assets, creditor's rights and debts, personnel, etc.

3. The situation of the subject matter of the transaction

IAMA-001 small nucleic acid immunomodulator nasal spray drug is independently developed by JSEM

An innovative immunomodulatory small nucleic acid nasal spray, mainly used for the treatment of seasonal allergic rhinitis, is the world's first nasal spray immunomodulatory small nucleic acid drug independently developed and entered the clinical trial stage. The licensed product has completed Phase I clinical trials in China, demonstrated superior safety and tolerability, and demonstrated target-mediated biological activity, and is about to enter Phase II clinical trials.

Fourth, the main content of the license and cooperation agreement

(1) Licensing and cooperation

1. Greater China license

JSMA grants Juntuo Biotech the exclusive license right to develop, improve, manufacture, produce, use, declare, register, commercialize and otherwise exploit the Licensed Products in Greater China based on the Licensed Intellectual Property Rights.

2. Cooperation outside Greater China

Juntuo Biotech and JSMA have cooperated in the development of IAMA-001 nasal spray project outside Greater China, and both parties are entitled to the equity share of the licensed product outside Greater China according to the agreed equity ratio. Unless otherwise agreed between JSMA and Juntuo, Juntuo shall bear the costs incurred or related to the clinical trials of the licensed products and the production of the licensed products required for clinical trials outside of Greater China.

3. Sub-licensing and subcontracting

(1) Juntuo Biotech has the right to further sublicense the license rights in Greater China to Juntuo's affiliates or third parties who are not listed in the list of competitors of JSEM;

(2) Juntuo Biotech has the right to engage third-party subcontractors in Greater China to perform any part of its R&D, manufacturing and commercialization obligations under the Agreement.

4. Priority negotiation and cooperation

In the event that JSMA intends to carry out any licensing, sub-licensing, commercialization cooperation, transfer, sale or disposal of any other dosage form of the licensed product in any area of the cooperation area, Juntuo Biopharma shall enjoy the right of first refusal to negotiate and cooperate with such other dosage forms of IAMA-001 under the same conditions.

(2) Financial terms

1. Down payment

After the signing of the license and cooperation agreement, Juntuo Biotech will pay an upfront payment of RMB 40 million to JSM.

2. R&D milestones

Juntuo Biotech will pay no more than RMB 240 million to JSMA according to the progress of the research and development of the licensed products

R&D milestones in Greater China and payment of up to US$150 million to JSEM for R&D milestones outside Greater China following marketing approval from United States and EU drug regulatory authorities for the first indication of the licensed product.

3. Sales milestones and sales commissions in Greater China

Based on the sales of the licensed products in Greater China, Juntuo will pay a sales milestone of up to RMB250 million and a single-digit percentage of the annual net sales of the licensed products in Greater China.

4. Arrangements for rights and interests outside Greater China

The parties agree to a 50%:50% equity interest in all rights and interests of the Licensed Products outside of Greater China, plus a revenue share.

(3) Term and Termination

The license and cooperation agreement shall come into force on the date of signing by both parties, unless terminated earlier by either party in accordance with this agreement, and this agreement shall terminate on the date of the tenth anniversary of the first commercial sale of the licensed product in the cooperation area (hereinafter referred to as the "initial term"). The term of this Agreement (the "Term of this Agreement") will be automatically extended once upon expiration of the Initial Term for a period of ten years, unless either party notifies the other party in writing that it will not renew it one hundred and eighty days prior to the expiration of the Initial Term. Upon the expiration of the term of this Agreement, JSMA shall grant Juntuo Biologics an irrevocable, perpetual, non-exclusive worldwide license under the license fee paid under the licensed intellectual property rights.

(4) Governing Law and Dispute Resolution

The license and cooperation agreement shall be governed by the laws of Chinese mainland. Disputes that cannot be resolved through negotiation shall be submitted to the China International Economic and Trade Arbitration Commission Shanghai Sub-Commission for arbitration in Shanghai.

5. The impact of the performance of the agreement on the company

The signing of this license and cooperation agreement is in line with the company's overall development strategy, which is conducive to enriching the company's R&D pipeline, improving the company's market layout, and providing treatment options for unmet clinical needs in the market, which will have a positive impact on the company's continued operations. The transaction will not have a material impact on the Company's recent production and operation, financial condition and results of operations. The signing of this agreement will not lead to changes in the company's main business and business scope, has no impact on the company's independence, and does not harm the interests of the company and its shareholders.

6. Risk Warning

Due to the characteristics of high-tech, high-risk, and high value-added pharmaceutical products, the product has a long cycle and many links from R&D, clinical trial approval to production, and is easily affected by some uncertain factors, and is finally licensed

There are certain risks associated with whether the product can be successfully approved for marketing. In addition, the payment of milestone payments and sales commissions agreed in the licensing and cooperation agreements is subject to certain conditions, and the final payment amount is uncertain. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

The company will fulfill its information disclosure obligations on the follow-up progress of the project in a timely manner in strict accordance with the relevant regulations. 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

September 27, 2024

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