SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences
Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-
driven biopharmaceutical company dedicated to the discovery, development, and
commercialization of novel therapies, announced its financial results for the
full year of 2023 and provided corporate updates.
FINANCIAL HIGHLIGHTS

  * Total revenue was approximately RMB1,503 million during 2023. The revenue
    from pharmaceutical products increased by approximately 58% compared to
    2022. The sales revenue of TUOYI® (toripalimab) was approximately RMB919
    million, representing an increase of approximately 25% compared to the
    previous year.
  * Total research and development ("R&D") expenses were approximately RMB1,937
    million in 2023, representing a decrease of approximately 19% compared to
    2022. The decrease in R&D expenses was mainly due to the strategic
    management of R&D investments in certain early-stage pipelines, while
    optimizing resource allocation and focusing on R&D pipelines with greater
    potential.
  * Loss attributable to owners was RMB2,282 million in 2023, representing a
    decrease of RMB104 million compared to the previous year.

BUSINESS HIGHLIGHTS
During 2023, we continued to focus on "unmet medical needs" and have made
original, innovative and breakthrough progress in discovery, R&D and
commercialization of innovative therapies and novel drugs. Here are the notable
achievements and milestones:

  * Advancements in the pipeline: Junshi Biosciences' innovative R&D field has
    expanded from monoclonal antibodies to the research and development of more
    drug modalities, including small molecules drugs, polypeptide drugs,
    antibody-drug conjugates (ADCs), bi-specific or multi-specific antibodies
    and nucleic acid drugs, as well as the exploration of next-generation
    innovative therapies including cancer and autoimmune diseases. The product
    pipelines cover five major therapeutic areas, including malignant tumors,
    autoimmune diseases, chronic metabolic diseases, neurologic diseases and
    infectious diseases. A total of three drugs (TUOYI®, JUNMAIKANG and

MINDEWEI) are being commercialized, around 30 assets are undergoing clinical

    trials, and over 20 drug candidates are at the preclinical drug development
    stage.
      * In January 2023, the marketing of MINDEWEI (Deuremidevir Hydrobromide
        Tablets, code: JT001/VV116), an oral nucleoside analog anti-SARS-CoV-2
        Category 1 innovative drug, was conditionally approved by the National
        Medical Products Administration of China (the "NMPA") for the treatment
        of adult patients with mild to moderate COVID-19.

* In February 2023, the United Kingdom's Medicines and Healthcare products

        Regulatory Agency (the "MHRA") accepted the the marketing authorization
        application (the "MAA") for toripalimab combined with cisplatin and
        gemcitabine for the first-line treatment of patients with locally
        recurrent or metastatic nasopharyngeal carcinoma ("NPC"), as well as
        toripalimab combined with paclitaxel and cisplatin for the first-line
        treatment of patients with unresectable locally advanced/recurrent or
        metastatic esophageal squamous cell carcinoma ("ESCC").
      * In March 2023, the investigational new drug ("IND") application for
        JS010 (a recombinant humanized anti-CGRP monoclonal antibody injection)
        was approved by the NMPA.
      * In April 2023, the NMPA accepted the supplemental new drug application
        ("sNDA") for TUOYI® in combination with chemotherapy as perioperative
        treatment and monotherapy as consolidation therapy after adjuvant
        therapy for the treatment of resectable stage III non-small cell lung
        cancer ("NSCLC"). This application was later approved for marketing in

December 2023, marking the first and only approved perioperative therapy

        for lung cancer domestically.
      * In April 2023, the new drug application ("NDA") for ongericimab (a
        recombinant humanized anti-PCSK9 monoclonal antibody, code: JS002) was
        accepted by the NMPA.
      * In April 2023, the IND application for JS401 (a small interfering RNA
        ("siRNA") drug targeting angiopoietin-like protein 3 ("ANGPTL3")
        messenger RNA ("mRNA")) was approved by the NMPA.
      * In May 2023, the NMPA accepted the sNDA for TUOYI® in combination with

paclitaxel injection (albumin-bound) for the treatment of PD-L1 positive

        (CPS >= 1) untreated metastatic or recurrent metastatic triple-negative
        breast cancer.
      * In June and August 2023, the IND application for a randomized, double-

blind, placebo-controlled, international multi-center phase III clinical

        study of tifcemalimab (a recombinant humanized anti-BTLA monoclonal
        antibody, code: TAB004/JS004) in combination with toripalimab as
        consolidation therapy in patients with limited-stage small cell lung
        cancer ("LS-SCLC") without disease progression following chemo-
        radiotherapy was approved by the U.S. Food and Drug Administration (the
        "FDA") and the NMPA, respectively.
      * In July 2023, the sNDA for TUOYI® in combination with axitinib for the
        first-line treatment of patients with unresectable or metastatic renal
        cell carcinoma ("RCC") was accepted by the NMPA.
      * In July 2023, the sNDA for TUOYI® in combination with etoposide plus
        platinum as the first-line treatment of extensive-stage small cell lung
        cancer ("ES-SCLC") was accepted by the NMPA, which marked the tenth
        marketing application submitted for TUOYI® in China.
      * In August 2023, the IND application for JS207 (a recombinant humanized
        anti-PD-1/VEGF bispecific antibody) was approved by the NMPA.
      * In September 2023, the primary endpoint of progression free survival
        ("PFS", based on independent radiological review) of a randomized,
        controlled, multi-center phase III clinical study (NCT03430297) of
        toripalimab versus dacarbazine for the first-line treatment of
        unresectable or metastatic melanoma had met the pre-defined efficacy
        boundary.

* In October 2023, the FDA approved the Biologics License Application (the

        "BLA") for toripalimab (U.S. trade name: LOQTORZI(TM)), in combination with
        cisplatin and gemcitabine for the first-line treatment of adults with

metastatic or recurrent locally advanced NPC, and as a single agent, for

        the treatment of adults with recurrent, unresectable, or metastatic NPC
        with disease progression on or after platinum-containing chemotherapy.

Toripalimab is the first and only drug approved in the United States for

        the treatment of NPC, and is also the first innovative biological drug
        independently developed and manufactured in China that was approved for
        marketing by the FDA.
      * In December 2023, the Therapeutic Goods Administration (the "TGA") of
        the Australian Government's Department of Health and Aged Care accepted
        the New Chemical Entity (the "NCE") application for toripalimab in
        combination with cisplatin and gemcitabine for the first-line treatment
        of adults with metastatic or recurrent locally advanced NPC, and as a
        single agent, for the treatment of adults with recurrent, unresectable,
        or metastatic NPC with disease progression on or after platinum-
        containing chemotherapy. Additionally, the TGA also granted an orphan
        drug designation to toripalimab for the treatment of NPC.
      * In December 2023, TUOYI® and MINDEWEI were successfully added to
        Category B of the National Drug List for Basic Medical Insurance, Work-
        Related Injury Insurance and Maternity Insurance (Year 2023) (the
        "NRDL") upon negotiations. Notably, three new TUOYI® indications were
        added, bringing the total to six indications included in the NRDL.
        TUOYI® is the only anti-PD-1 monoclonal antibody included in the NRDL
        for the treatment of melanoma. The inclusion of the MINDEWEI indication
        for adult patients with mild to moderate COVID-19 marked its first
        official listing in the NRDL.
  * Update on external collaborations
      * In March 2023, the company entered into a shareholders agreement with

Rxilient Biotech and its wholly-owned subsidiary, Excellmab. The company

        would subscribe to the newly issued shares of Excellmab by payment in
        kind to obtain 40% equity interest in Excellmab. Subject to the

fulfillment of the conditions precedent as agreed under the Shareholders

        Agreement, the company would substantially perform its capital
        contribution obligations, and express its intention to enter into a
        license agreement with Excellmab in the form agreed upon by the parties
        at the time of entering into the Shareholders Agreement, thereby
        granting Excellmab an exclusive license and other relevant rights to
        develop and commercialize intravenous toripalimab in Thailand, Brunei,
        Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines and

Vietnam. According to the R&D progress of toripalimab and other matters, Junshi Biosciences may receive a milestone payment of up to
approximately US$4.52 million, plus a percentage of royalties on the net

        sales.
      * In May 2023, Junshi Biosciences entered into an exclusive license and
        commercialization agreement with Dr. Reddy's, pursuant to which the

company agreed to grant Dr. Reddy's a license to develop and exclusively

        commercialize toripalimab injection in Brazil, Mexico, Colombia,
        Argentina, Peru, Chile, Panama, Uruguay, India and South Africa. Dr.

Reddy elected to expand the scope of the license to cover Australia, New Zealand and nine other countries.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an
innovation-driven biopharmaceutical company dedicated to the discovery,
development and commercialization of innovative therapeutics. The company has
established a diversified R&D pipeline comprising over 50 drug candidates, with
five therapeutic focus areas covering cancer, autoimmune, metabolic,
neurological, and infectious diseases. Four of the company's innovations have
already reached the Chinese or international markets, one of which is
toripalimab, China's first domestically produced and independently developed
anti-PD-1 monoclonal antibody, approved in both China and the US. Additionally,
more than 30 drugs are currently in clinical development. During the COVID-19
pandemic, Junshi Biosciences actively shouldered the social responsibilities of
a Chinese pharmaceutical company through its involvement in developing
etesevimab, MINDEWEI®, and other novel therapies for the prevention and
treatment of COVID-19.
With a mission of "providing patients with world-class, trustworthy, affordable,
and innovative drugs," Junshi Biosciences is "In China, For Global." At present,
the company boasts approximately 3,000 employees in the United States (San
Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc).
For more information, please visit: http://junshipharma.com.
Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com (mailto:info@junshipharma.com)
+ 86 021-6105 8800
PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com (mailto:zhi_li@junshipharma.com)
+ 86 021-6105 8800
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