Junshi Biosciences Announces 2023 Interim Financial Results and Provides Corporate Updates

SHANGHAI, China, Aug. 30, 2023 (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 2023 interim financial results and provided corporate updates.

FINANCIAL HIGHLIGHTS

• As of 30 June 2023, the company’s total revenue was approximately RMB670 million, representing a decrease of approximately 29% compared to the corresponding period in 2022, which was mainly due to the decrease in income related to out-licensing from overseas. During the Reporting Period, the company’s revenue from pharmaceutical products increased significantly. In particular, the sales revenue of TUOYI® (toripalimab) was approximately RMB447 million, representing an increase of approximately 50% compared to the corresponding period in 2022; the sales revenue of MINDEWEI, a newly launched product, was approximately RMB110 million during the Reporting Period.
• The company’s total R&D expenses were approximately RMB949 million during the first half of 2023, representing a decrease of approximately 11% compared to the corresponding period in 2022. The decrease in R&D expenses was mainly due to the company’s strategic management of R&D investments in certain early-stage pipelines, choosing to optimize resource allocation and focus on R&D pipelines with greater potential.

BUSINESS HIGHLIGHTS

During the first half of 2023, we focused on “unmet medical needs”. We have made original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and novel drugs. The following achievements and milestones were attained:

• Advancements in the pipeline: the company’s 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. As of the date of this announcement, 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 pre-clinical 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, for the treatment of adult patients with mild to moderate COVID-19 was conditionally approved by the National Medical Products Administration of China (the “NMPA”).
  • In February 2023, 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”), 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”) was accepted by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (the “MHRA”).
  • 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 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”) was accepted by the NMPA.
  • 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 sNDA for TUOYI® in combination with paclitaxel for injection (albumin-bound) for the treatment of PD-L1 positive (CPS ≥ 1) untreated metastatic or recurrent metastatic triple-negative breast cancer was accepted by the NMPA.
  • In June 2023 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 June 2023, the IND application for JS207 (a recombinant humanized anti-PD-1/VEGF bispecific antibody) was accepted by the NMPA.
  • 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 is the tenth marketing application submitted for TUOYI® in China.

• Update on external collaborations
  • In March 2023, we entered into a shareholders agreement with Rxilient Biotech and its wholly-owned subsidiary, Excellmab. We will 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, we will substantially perform our capital contribution obligations, and we intend to enter into a license agreement with Excellmab in the form as 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 progress of the R&D of toripalimab and other matters, we may receive a milestone payment of up to approximately US$4.52 million, plus a percentage of royalty on the net sales.
  • In May 2023, we entered into an exclusive license and commercialization agreement with Dr. Reddy’s, pursuant to which we 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 may elect to expand the scope of the license to cover Australia, New Zealand and nine other countries.

• Business operations
  • In June 2023, the resolutions in relation to the proposed issuance of global depositary receipts (“GDR”) and application for admission on the SIX Swiss Exchange were passed by the shareholders of the Company at the 2022 annual general meeting. The gross proceeds are expected to be no more than approximately RMB3.4 billion, which are proposed for R&D projects of innovative drugs, the construction project of Junshi Biotech Industrialization Base and the replenishment of liquidity.
  • In June 2023, Dr. Meng Anming was appointed as an independent non-executive Director of the Company. Dr. Meng Anming was elected as an academician of the Chinese Academy of Sciences in 2007 and an academician of The World Academy of Sciences for the advancement of science in developing countries in 2008. He is currently a professor at the School of Life Sciences, Tsinghua University.

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 China’s first anti-PD-1 monoclonal antibody, toripalimab. 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
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800