Junshi Bio: Junshi Bio voluntarily disclosed the announcement on the establishment of a joint venture with Conlida Biotech in Southeast Asia to cooperate in the development and commercialization of Treplimab.
DATE:  Mar 29 2023

Stock code: 688180 Stock abbreviation: Junshi Biological Announcement No.: Pro 2023-017.

SHANGHAI JUNSHI BIOMEDICAL TECHNOLOGY CO., LTD

Voluntary disclosure on the establishment of a joint venture company with Conrad.

Announcement on the Development and Commercialization of Treplimab in Southeast Asia

the company's board of directors and all directors to ensure that the contents of this announcement does not exist any false records, misleading statements or major omissions, and the authenticity, accuracy and completeness of the contents of the legal responsibility.

Important Content Tips:

On March 27, 2023, Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as "Public

Division ") and Rxilient Biotech Pte. Ltd. (hereinafter referred to as" Companda Biotech ") and its wholly-owned subsidiaries.

ExcellmabPte.Ltd. (hereinafter referred to as the "Excellmab") entered into a shareholder agreement (hereinafter referred to as the "shareholder agreement") in which the company will subscribe for the newly issued shares of the Excellmab in a non-monetary manner to acquire 40% of its equity. Subject to the achievement of the conditions precedent agreed under the Shareholder Agreement, the Company will substantially perform its capital contribution obligations and plans to enter into an exclusive license agreement with the Excellmab in accordance with the text agreed upon by the parties at the time of the conclusion of the Shareholder Agreement (the "License Agreement"), grant Excellmab exclusive license and other related rights to develop and commercialize intravenous terrepilimumab in Thailand, Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines and Vietnam (the "Cooperation Area") (collectively the "Transaction").

The transaction does not constitute a connected transaction, nor does it constitute the Administrative Measures for the Reorganization of Major Assets of Listed Companies.

The provisions of the major asset restructuring.

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

The payment agreed upon in the license agreement is subject to certain pre-conditions, the final payment amount and the right.

The impact of the company's future operating income and profits is uncertain. Please the majority of investors cautious decision-making, pay attention to prevent investment risk.

1. Transaction Overview

On March 27, 2023, the Company entered into a Excellmab with Conlink Technology and its wholly-owned subsidiaries as shareholders.

The agreement, the company will subscribe for Excellmab newly issued shares in a non-monetary manner to acquire a 40% stake. Subject to the fulfillment of the conditions precedent agreed under the Shareholder Agreement, the Company will substantially fulfill its capital contribution obligations and plans to enter into a license agreement with the Excellmab in accordance with the text agreed upon by the parties at the time of the conclusion of the Shareholder Agreement, granting Excellmab an exclusive license and other related rights to develop and commercialize intravenous teripilimumab in the Cooperative Area.

According to the Rules Governing the Listing of Shares on the Science and Technology Board of the Shanghai Stock Exchange and the Articles of Association of Shanghai Junshi Biopharmaceutical Technology Co.

this transaction does not constitute a connected transaction, nor does it constitute a major asset restructuring of the listing Corporation's major asset restructuring management approach.

2. of the subject matter of the license agreement

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 30 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, Treprimab has been awarded by the U.S. Food and Drug Administration (hereinafter referred to as "FDA") in the fields of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, esophageal cancer and small cell lung cancer. 2 breakthrough therapy accreditation, 1 fast track accreditation, 1 priority review accreditation and 5 orphan drug accreditation. 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.

Bureau (MHRA) submitted teripilimumab in combination with cisplatin and gemcitabine for locally recurrent or metastatic nasal

The first-line treatment of patients with pharyngeal cancer and the combination of paclitaxel and cisplatin for first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (MAA) were separately accepted.

3. basic information of the counterparty

Kanglianda Biotech was established in Singapore in November 2021 and is a holding subsidiary of China Medical SystemHoldings Limited (a company listed on the Stock Exchange of Hong Kong Limited, stock code: 867, hereinafter referred to as "Kangzhe Pharmaceutical"). Conlida Biotech and other Southeast Asian business companies of Conlida Pharmaceuticals (collectively referred to as "Conlida" with Conlida Biotech) are an open platform integrating innovative research, customized preparation development and production (CDMO), production, sales and promotion. Combining Kangzhe Pharmaceutical's ability to invest and acquire high-quality products in the world for more than 20 years, excellent market commercialization experience, strong self-owned cash flow and leading venture capital and investment and financing concepts, Concord will introduce high-quality drugs into Southeast Asia through cooperation with leading global biomedical enterprises, and finally realize local production, exploring the construction of a "bridgehead" for the global pharmaceutical industry in Southeast Asia and going global.

According to the financial statements of Kangzhe Pharmaceutical (prepared in accordance with IFRS and audited), as of December 31, 2022, Kangzhe Pharmaceutical had total assets of RMB 17.754 billion and net assets of RMB 14.737 billion; in 2022, it achieved operating income of RMB 9.15 billion and net profit of RMB 3.276 billion.

Excellmab was established in Singapore in February 2023. Prior to the conclusion of the Shareholder Agreement, the Excellmab was a wholly-owned subsidiary of Conrad Biotech.

Conlida Biotech and Excellmab are not related to the Company. Except for this transaction, there is no other relationship between Conlianda Biotech, Excellmab and the Company in terms of property rights, business, assets, debts and personnel.

Main Contents of 4. Shareholders' Agreement

Condor Biotech will subscribe for the newly issued shares of the Excellmab for $4,999,999, and the company will grant

Payment of the subscription amount of the Shareholder Agreement by way of Excellmab the relevant rights in the License Agreement. After the completion of this issue, the Excellmab will be 60% and 40% owned by Comlianda Biotech and the company respectively.

The Excellmab will be responsible for the development, medical affairs, production and commercialization of related products in the cooperation area. Excellmab profits available for distribution will be distributed in accordance with the respective shareholdings of the contracting parties.

Main contents of 5. license agreement

(I) Licensed Content

1. Treplimab: The Company grants the Excellmab exclusive license and other related rights to develop and commercialize intravenous treplimab (including any human tumor indications that have been approved or will be approved for marketing by applicable regulatory agencies) in the cooperative area.

2. Priority negotiation right: If the company decides to grant the other four research products agreed in the license agreement to a third party in one or more countries in the cooperation area, the Excellmab will have the priority negotiation right for commercialization.

(II) financial terms

Depending on the progress of Treplimab research and development and other matters, the Company may receive a milestone payment of up to approximately $4.52 million, plus a percentage of royalties on net sales.

(III) applicable law

The License Agreement is governed by the laws of Singapore.

6. the impact of this transaction on the company.

This transaction is an important practice for the company to continue to expand its global commercialization network, which will further help the company's products to quickly penetrate the Southeast Asian market. Through the establishment of a joint venture cooperation model, the two parties combine the registration and commercialization advantages of Kanglianda and the company's strong R & D capabilities to achieve complementary advantages and strong alliances. Treplimab is one of the important varieties of Chinese innovative drugs going to sea. With this cooperation, the two sides will introduce this important innovative drug into the Southeast Asian market, which is expected to realize the commercialization of Chinese anti-PD-1 monoclonal antibody products in Southeast Asian countries for the first time. Relying on the platform of the joint venture company, the company also plans to conduct in-depth cooperation with Kanglianda to introduce more high-quality innovative drugs developed into the Southeast Asian market, so as to achieve common and rapid development of both sides.

7. Risk Alert

Due to the high-tech, high-risk, and high-value-added characteristics of pharmaceutical products, the product has a long cycle and many links from research and development, clinical trial approval to production, and is susceptible to some uncertain factors. Finally, there is a certain degree of uncertainty about whether the injection can be successfully commercialized in the cooperation area. In addition, the payments agreed in the license agreement are subject to certain pre-conditions, and the final payment amount and its impact on the Company's future operating income and profits are uncertain. Therefore, please the majority of investors cautious decision-making, pay attention to prevent investment risks. The company will be in accordance with the relevant provisions of the follow-up progress of the project in a timely manner 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

29 March 2023

Follow Yicai Global on

star50stocks

Ticker Name

Percentage Change

Inclusion Date