Junshi Biosciences Announces 2021 Interim Financial Results and Provides Corporate Updates

SHANGHAI, China, Aug. 31, 2021 (GLOBE NEWSWIRE) -- 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 six months ended June 30, 2021 and provided corporate updates.

First Half 2021 Financial Highlights

• Total revenue reached RMB 2,114 million in the first half of 2021, representing an increase of 268% compared to the corresponding period of 2020. The increase was mainly due to the growth of revenue from out-licensing income.
• Total research and development ("R&D”) expenses were RMB 947 million in the first half of 2021, representing an increase of 34% compared to the corresponding period of 2020. The increase in R&D expenses was mainly due to increased investment in in-house R&D projects, expansion of innovative R&D fields, and a greater number of R&D collaborations and license-in activities.
• Profits in the first half of 2021 were RMB 11 million compared to a loss of RMB 598 million in the corresponding period of 2020. The turnaround in profit was mainly due to significant increase in revenue.
• Net cash from operating activities was RMB 48 million for the six months ended June 30, 2021. Net cash from financing activities was RMB2,028 million during the period, which was mainly due to the successful placing of new H shares with net proceeds of approximately RMB 2,106 million in June 2021.
• As of June 30, 2021, we had cash and cash equivalents of RMB 4,269 million as compared to the RMB 3,385 million as of December 31, 2020. The increase was mainly due to funds raised from the aforementioned stock offering and cash inflow from operations.
  

Business Highlights
During the six months ended June 30, 2021, we have achieved significant progress with respect to our product commercialization, clinical trials and pipeline expansion. Our innovative R&D field has expanded from monoclonal antibodies to the development of more drug modalities, including small molecules, polypeptides, antibody drug conjugates (ADCs), bi-specific or multi-specific antibodies and nucleic acid drugs, as well as the exploration of next-generation innovative therapies for cancer and autoimmune diseases. Our drug candidates cover 5 major therapeutic categories including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases, and infectious diseases. Currently, we have 2 commercialized products (toripalimab and etesevimab), one filed NDA (adalimumab), 16 drug candidates under clinical trials (among which senaparib, ongericimab and bevacizumab were in Phase III trials) and 25 drug candidates in pre-clinical drug development.

• In January 2021, toripalimab for the first-line treatment of mucosal melanoma was granted the Fast Track Designation by the United States Food and Drug Administration (the "FDA”). Meanwhile, the FDA also approved the Investigational New Drug ("IND”) application for a global Phase III clinical trial of toripalimab in combination with axitinib for the first-line treatment of mucosal melanoma. In March 2021, the indication was granted Breakthrough Therapy Designation ("BTD”) by the National Medical Products Administration (the "NMPA”) of China.
• In February 2021, we entered into an exclusive license and commercialization agreement with Coherus BioSciences, Inc. ("Coherus”). Pursuant to the agreement, we granted Coherus an exclusive license for toripalimab and two option programs in the United States and Canada (the "Coherus Territory”), as well as the rights of first negotiation for 2 early-stage checkpoint inhibitor antibodies, and may receive an aggregate of up to US$1.11 billion in upfront payments, exercise fees and milestone payments. Coherus paid us an upfront payment of US$150 million.
• In February 2021, the supplemental new drug application ("sNDA”) for toripalimab in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma ("NPC”) was accepted by the NMPA.
• In February 2021, the sNDA for toripalimab for the treatment of patients with recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy was granted conditional approval by the NMPA.
• In January and February 2021, TAB006/JS006 (specific anti-TIGIT monoclonal antibody) received IND approval from the NMPA and the FDA, respectively.
• In February 2021, the FDA granted Eli Lilly and Company ("Lilly”), our partner, an Emergency Use Authorization ("EUA”) for etesevimab (JS016/LY-CoV016) 1,400 mg and bamlanivimab (LY-CoV555) 700 mg together.
• In February 2021, the IND applications for JS110 (XPO1 inhibitor) and JS111 (EGFR exon20 insertion and other uncommon mutation inhibitor) jointly developed by Wigen Biomedicine Technology (Shanghai) Co., Ltd. and us were accepted by the NMPA. They were subsequently approved in April 2021.
• In February 2021, the IND application for our drug candidate JS201 (anti-PD-1/TGF-ß bifunctional fusion protein) was accepted by the NMPA and was later approved in May 2021. In July 2021, the dosing of the first patient was completed in a Phase I clinical trial (NCT04956926).
• In February 2021, we entered into an exclusive promotion agreement with AstraZeneca Pharmaceutical Co., Ltd. ("AstraZeneca”), pursuant to which we granted AstraZeneca the exclusive promotion right of toripalimab for the urinary cancer indications to be approved subsequently in mainland China and the exclusive promotion right for all indications approved and to be approved in non-core urban areas. We will continue to be responsible for the promotion of other indications approved and to be approved, excluding urinary cancer indications in core urban areas.
• In March 2021, we initiated the rolling submission of a Biologics License Application ("BLA”) for toripalimab to the FDA for the treatment of recurrent or metastatic NPC, and obtained a rolling review.
• In March 2021, the IND application for our drug candidate JS103 (pegylated uricase derivative) was accepted by the NMPA. It was later approved in May 2021.
• In March 2021, the IND application for our drug candidate JS007 (anti-CTLA-4 monoclonal antibody) was accepted by the NMPA. It was later approved in June 2021.
• In April 2021, the sNDA for toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma ("UC”) who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy was granted conditional approval by the NMPA.
• In April 2021, the Independent Data Monitoring Committee (IDMC) determined that toripalimab in combination with paclitaxel/cisplatin as the first-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma ("ESCC”) had reached its pre-specified primary endpoints of Progression Free Survival ("PFS”) and Overall Survival ("OS”) at the interim analysis of a randomized, double-blind, placebo-controlled, multi-center, Phase III clinical study "JUPITER-06 study” (NCT03829969). In July 2021, the sNDA for toripalimab in combination with platinum-containing chemotherapy as the first-line treatment for patients with locally advanced or metastatic ESCC was accepted by the NMPA.
• In June 2021, the IND application for our drug candidate JS014 (recombinant IL-21 – a nanobody fusion protein of anti-human serum albumin (HSA)) was accepted by the NMPA.
• In August 2021, the IND application for our drug candidate UBP1213sc (recombinant humanized anti-B lymphocyte stimulator (BLyS) monoclonal antibody) was accepted by the NMPA.

We expanded our product pipeline through forming joint ventures with our partners and other means. Apart from developing drug candidates on our own technology platforms, we also actively collaborated with outstanding domestic and overseas biotechnology companies to further expand our product pipeline, deploy next-generation innovative drug technology platforms and augment drug combination therapies.

• In July 2021, we entered into an agreement with Immorna (Hangzhou) Biotechnology Co., Ltd. ("Immorna”) to jointly create a new company. The newly created company will mainly engage in R&D and commercialization of products in the fields of tumors, infectious diseases, rare diseases and other diseases on the mRNA technology platform globally. Upon its formation, 50% of the new company will be owned by Junshi Biosciences and 50% by Immorna.
  

In June 2021, we issued an aggregate of 36,549,200 new H shares at the placing price of HK$70.18 per H share to no less than six placees (the "Placing”). The net proceeds from the Placing are approximately RMB 2,106 million. The proceeds from the Placing are intended for increased R&D, expansion of the commercialization team, domestic and overseas investments, mergers and acquisitions, business development, and general corporate purposes.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences 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 44 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has obtained the EUA in more than 12 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Contact Information

IR Team:
Junshi Biosciences
info@junshipharma.com
+86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com
+1 646-389-6658

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