-Tackling the COVID-19 pandemic challenge with multi-pronged strategies

– Pipeline progressed and expanded substantially

SHANGHAI, China, March 31, 2022 (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, today announced financial results for the full year 2021 and provided corporate updates.

Full Year 2020 Financial Highlights

• Total revenue reached RMB 4,025 million in 2021, representing an increase of 152% compared to the year 2020. Revenue from out-licensing significantly increased to RMB3,341 million, which is based on two cooperation projects: 1) the research collaboration and license agreement with Lilly and Company (“Lilly”); 2) the license and commercialization agreement with Coherus BioSciences, Inc. (“Coherus”). Sales of toripalimab was RMB 412 million for the year. The decrease was mainly due to a 60% reduction in reimbursement price of toripalimab in 2021 and the adjustment of the value of wholesalers’ inventories. With a new sales leadership and strategy and additional approved indications, the company is confident that it can gain market share in the approved indications that have been included in NRDL.
• Total research and development (“R&D”) expenses were RMB2,069 million, representing an increase of 16% compared to the prior year. The increase in R&D expenses was mainly due to: 1) continuous increasing R&D investment, continuous diversification and expansion of product pipelines; 2) the acceleration of the development of existing clinical projects; and 3) expansion of the R&D team and investment in attracting and retaining personnel.
• Total comprehensive expense was RMB719 million, representing a decrease of 57% compared to the prior year. The decrease was mainly attributable to the increase of revenue from out-licensing, partially offset by the increasing R&D expenses, administrative expenses and selling and distribution expenses.
• Net cash from financing activities was RMB2,666 million, which was mainly attributable to the successful placing of the company’s new H shares on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on 23 June 2021 with net cash inflows of RMB2,105 million and receipts of capital contribution from external investors to Shanghai JunTop Biosciences Co., Ltd. (“JunTop Biosciences”), a non-wholly owned subsidiary with net cash inflows of RMB895 million. This cash inflow fully covered the cash used in operating and investing activities, leading to an increase of RMB120 million in cash and cash equivalents.
• Cash and cash equivalents as of December 31, 2021 were approximately RMB3,505 million. In March 2022, the Board passed a resolution and proposed to issue 70 million A Shares to target subscribers, and the total proceeds are expected to be approximately RMB3,980 million.

Business Highlights

During the year 2021 and 2022 to date, Junshi Biosciences continuously adhered to the strategic plan of “International layout with a base in China,” and has achieved significant growth in operating income, which gradually demonstrated its “income generation” capability. In addition, several of its R&D pipelines have reached key milestones. Junshi has also achieved progress with respect to product commercialization, clinical trials and pipeline expansion, including the following achievements and milestones:

• Advancement in pipeline: The company’s innovative R&D field has expanded from monoclonal antibodies to the development of more drug modalities, including small molecules, 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 for cancer and autoimmune diseases. Product pipelines cover 5 major therapeutic areas including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases. There are 3 assets (toripalimab, etesevimab and adalimumab) under commercialization, 23 assets under clinical trials with ongericimab, VV116, bevacizumab, and PARP inhibitor under Phase III clinical trials, and over 25 drug candidates under 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 an immediate 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 of China (the “NMPA”).
  • In February 2021, Junshi Biosciences entered into an Exclusive License and Commercialization Agreement with Coherus. Pursuant to the agreement, the Company granted Coherus an exclusive license for toripalimab and two option programs (if exercised) in the Coherus Territory, as well as the right of first negotiation for two early-stage checkpoint inhibitor antibodies, and may receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments. Coherus made a one-time upfront payment of US$150 million to the Company.
  • 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 November 2021, the indication was approved 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 (recombinant humanized anti-TIGIT monoclonal antibody) received IND approval from the NMPA and the FDA, respectively.
  • In February 2021, the IND applications for JS110 (XPO1 inhibitor) and JS111 (EGFR exon20 insertion and other uncommon mutation inhibitor) jointly developed by Junshi Biosciences and Wigen Biomedicine Technology (Shanghai) Co., Ltd. (“Wigen Biomedicine”) were accepted by the NMPA, and the company received IND approvals in April 2021.
  • In February 2021, the IND application for the drug candidate JS201 (anti-PD-1/TGF-β bifunctional fusion protein) was accepted by the NMPA, and the company received IND approval in May 2021.
  • In March 2021, TopAlliance Biosciences, Inc. (“TopAlliance”), the company’s wholly-owned subsidiary, initiated the rolling submission of Biologics License Application (“BLA”) for toripalimab to the FDA for the treatment of recurrent or metastatic NPC, and obtained a rolling review. Toripalimab has become the first domestic anti-PD-1 monoclonal antibody to submit a BLA to the FDA. In August 2021, toripalimab in combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic NPC was granted a BTD by the FDA. In September 2021, the company completed the rolling submission of BLA for the above two indications. At the end of October 2021, BLA for the above two indications was accepted by the FDA. According to the acceptance letter, the FDA has granted priority review designation for the BLA and indicated that it does not plan to hold an advisory committee meeting for the BLA. The Prescription Drug User Fee Act (the “PDUFA”) action date is set on or around April 2022.
  • In March 2021, the IND application for JS103 (pegylated uricase derivative) was accepted by the NMPA, and the company received IND approval in May 2021.
  • In March 2021, the IND application for JS007 (recombinant humanized anti-CTLA-4 monoclonal antibody) was accepted by the NMPA, and the company received IND approval 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 June 2021, the IND application for JS014 (recombinant IL-21 – a nanobody fusion protein of anti-human serum albumin (HSA)) was accepted by the NMPA, and the company received IND approval in August 2021.
  • 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 August 2021, the IND application for UBP1213sc (recombinant humanized anti-B lymphocyte stimulator (BLyS) monoclonal antibody) was accepted by the NMPA, and the company received IND approval in November 2021.
  • In September 2021, the IND application for JS012 (recombinant humanized anti-Claudin18.2 monoclonal antibody) was accepted by the NMPA. It was later approved in November 2021.
  • In October 2021, the IND application for JS019 (recombinant fully human anti- CD39 monoclonal antibody) jointly developed by Junshi Biosciences and Beijing Eirene Biotech Co., Ltd. (“Beijing Eirene”) was accepted by the NMPA. It was later approved in December 2021.
  • In October 2021, the IND application for JS026 (recombinant fully human monoclonal antibody for treatment of COVID-19) was accepted by the NMPA. It was later approved in November 2021.
  • In November 2021, the IND application for JS112 (Aurora A inhibitor) was accepted by the NMPA. It was later approved in February 2022.
  • In December 2021, the IND application for JS107 (recombinant humanized anti- Claudin18.2 monoclonal antibody – MMAE conjugate) was accepted by the NMPA. It was later approved in March 2022.
  • In December 2021, the IND application for JS001sc (a subcutaneous injection formulation developed on the basis of toripalimab) was accepted by the NMPA. It was later approved in March 2022.
  • In December 2021, the sNDA of toripalimab in combination with standard first-line chemotherapy for untreated, driver-negative advanced non-small cell lung cancer (“NSCLC”) was accepted by the NMPA.
  • In January 2022, based on the Exclusive License and Commercialization Agreement Junshi Biosciences entered into with Coherus in February 2021, Coherus initiated the procedure for exercising the option of TAB006/JS006, one of the option programs, to be licensed to develop TAB006/JS006 or any product containing TAB006/JS006 in the Coherus Territory for the treatment or prevention of human disease. Coherus will pay Junshi a one-time execution fee of US$35 million and cumulative milestone payment of up to US$255 million upon reaching the corresponding milestones, plus 18% royalty on the annual net sales of any product that contains TAB006/JS006 in the Coherus Territory.
  • In February 2022, the dosing of the first patient was completed in the Phase III clinical trial of toripalimab in combination with standard chemotherapy as the adjuvant treatment after radical resection of gastric or esophagogastric junction adenocarcinoma (JUPITER-15 study, NCT05180734).
  • In March 2022, the marketing of adalimumab (Commercial name in China: Junmaikang) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis was approved by the NMPA.
  • In March 2022, the IND application for JS105 (PI3K-α inhibitor) jointly developed by the company and Risen (Suzhou) Biosciences Co., Ltd. was accepted by the NMPA.
  • In March 2022, Junshi Biosciences entered into a licensing and cooperation agreement with Wigen Biomedicine to introduce four small molecule anti-tumor drugs, namely JS120 (second-generation irreversible IDH1 inhibitor), JS121 (SHP2 inhibitor), JS122 (second-generation irreversible FGFR2 selective inhibitor) and JS123 (ATR inhibitor), thus further enriching the pipeline in cancer therapy.
• Tackling the COVID-19 Challenge: In the face of the novel coronavirus pandemic (“COVID-19”), Junshi Biosciences responded swiftly and cooperated with domestic and foreign scientific research institutions and enterprises to jointly develop a variety of drug candidates for the treatment of the COVID-19, and took the initiative to undertake the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. The company has made significant progress.
  • Etesevimab (JS016/LY-CoV016): In early 2020, Junshi Biosciences jointly developed etesevimab with the Institute of Microbiology, Chinese Academy of Sciences (the “IMCAS”). Lilly licensed the rights and interests of etesevimab from the Company outside the greater China territories (including mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region and the Taiwan region), and Junshi continued to lead the development of the drug in the greater China territories. In February 2021, the FDA granted Lilly the Emergency Use Authorization (“EUA”) for etesevimab 1,400 mg and bamlanivimab (LY-CoV555) 700 mg together (the “dual antibody therapy”) for the treatment of patients with mild to moderate COVID-19 aged 12 and above who were at high risk for progressing to severe COVID-19 and/or hospitalization. In September 2021, the FDA granted the EUA for the dual antibody therapy for the application of treatment for high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison. In December 2021, the scope of EUA was newly extended to include treatment and post-exposure prevention of mild to moderate COVID-19 for specific high-risk pediatric populations (from infant to child aged under 12). As of the end of 2021, the dual antibody therapy has been granted the EUA in more than 15 countries and regions around the world, and more than 700,000 patients have received the dual antibody therapy or bamlanivimab treatment, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths during the worst period of the pandemic.
  • VV116 (JT001): In September 2021, JunTop Biosciences, a subsidiary of the Company, partnered with Suzhou Vigonvita Biomedical Co., Ltd. (“Vigonvita”) to jointly undertake the clinical development and commercialization of VV116, an oral nucleoside anti-SARS-CoV-2 drug, in the collaboration territory, being the whole world except for the following four territories, namely the five Central Asian countries, Russia, North Africa and the Middle East. VV116 was approved for the treatment of moderate to severe COVID-19 patients in Uzbekistan (not within the collaboration territory) in late 2021. The Company was conducting an international multi-center, randomized, double-blind, controlled phase III clinical study to evaluate the efficacy and safety of VV116 versus standard treatments in subjects with moderate to severe COVID-19. The enrollment and dosing of the first patient has been completed. In addition, for mild to moderate COVID-19, the Company has also initiated an international multi-center, double- blind, randomized, placebo-controlled, Phase II/III clinical study (NCT05242042) to evaluate the efficacy, safety and pharmacokinetics of VV116 for early treatment of patients with mild to moderate COVID-19. The study has completed the enrollment and dosing of the first patient in Shanghai Public Health Clinical Center and is in progress in multiple centers around the world.
  • VV993 (JT003): In January 2022, JunTop Biosciences partnered with Vigonvita to jointly undertake the research, production and commercialization of VV993, a new oral anti-SARS-CoV-2 drug candidate targeting 3CL protease, in the collaboration territory.
• Platform Expansion: Apart from developing drug candidates on Junshi Biosciences’ own technology platforms, the company has also actively collaborated with outstanding domestic and overseas biotechnology companies to further expand its product pipeline, deploy the next-generation innovative drug technology platform and enrich drug combination therapies.
  • In July 2021, Junshi Biosciences and Immorna (Hangzhou) Biotechnology Co., Ltd. (“Immorna”) entered into an agreement to start a JV, which will mainly engage in the R&D, clinical research, application for approval, production and commercialization of product development projects in the fields of tumors, infectious diseases, rare diseases and other diseases agreed by both parties on the mRNA technology platform globally. The jointly formed company will be owned 50% by the Company and 50% by Immorna upon its formation. The establishment of the jointly formed company can complement each party’s technological advantages, capitalize the strengths of the mRNA general platform technology in tumor immunotherapy, infectious disease prevention and other fields in a more efficient manner, and continuously explore new directions of application.
• Update on commercialization
  • Additional Indications included in NDRL: Toripalimab continued to be included in Category B in the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2021 Edition) (“NRDL”)). It was approved for two additional indications of the treatment of patients with recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy as well as the treatment of patients with locally advanced or metastatic UC who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy, and became the only anti-PD-1 monoclonal antibody used in the treatment of melanoma and nasopharyngeal cancer in the NRDL, which filled the gaps in immunotherapy for patients with advanced NPC and non-selective patients with advanced UC in the NRDL, and became the only anti-PD-1 monoclonal antibody used in the treatment of melanoma and nasopharyngeal cancer in the NRDL.
  • Toripalimab achieved sales of RMB412 million in 2021. After the official implementation of the 2020 NRDL in March 2021, the terminal pricing of toripalimab dropped by over 60% compared to the initial pricing in 2020. Moreover, after the continued inclusion in the 2021 NRDL and further price reduction of toripalimab at the end of 2021, the company compensated the price difference for the entire inventory of the distributors, which also had a certain impact on the recognition of product revenue for the current period. 2021 was also a relatively turbulent year for the commercialization team. The team underwent several rounds of adjustment in regards to commercialization managers and internal marketers. In November 2021, the Board of Directors of the Company appoint Mr. Cong Li as a co-chief executive officer to be fully responsible for commercialization-related activities. All necessary adjustments to the commercialization team have been made, and Mr. Cong Li has completed the establishment and restoration of the marketing regional team and also supplemented the core market personnel. In December 2021, after friendly negotiation, the company withdrew the promotion rights agreed in the agreement with AstraZeneca Pharmaceutical Co., Ltd., (“AstraZeneca Pharmaceutical”) that the company’s commercialization team would be independently responsible for all promotion activities of toripalimab in mainland China. Through urban commercial insurance across the country, out-of-pocket expenses on the indications of toripalimab included in the NRDL were entitled to supplementary reimbursement under the NRDL in 102 cities, and the newly approved first-line treatment for nasopharyngeal cancer indication in November 2021 has entered the medical insurance catalogues in 11 cities, for which supplementary medical insurance could be obtained in 51 cities, thus reducing the burden on patients. After the recovery of toripalimab outsourced indications and promotion right in wide market from AstraZeneca Pharmaceutical, and the inclusion of toripalimab in the NRDL for treatment of melanoma, nasopharyngeal and urothelial cancer, commercial team members have also regained their confidence. The sales activities of toripalimab in the domestic market bounced back to normal levels. A series of marketing campaigns had commenced, aiming to reshape the market image of the company and toripalimab. Junshi Biosciences is optimistic that it can gain market share in those tumor types that had been included in NRDL indications. More large indications of toripalimab have completed the Phase III registration clinical trials and entered the commercial approval stage. With the gradual realization of the prospective layout advantages of multi-indication perioperative clinical research as well as the upgrade in production capacity of commercial production batches of the company’s production base, Junshi Biosciences is very optimistic about the long-term commercial opportunity of toripalimab in the domestic market.
  • In March 2022, Shanghai Junshi Biotechnology Co., Ltd. (“Junshi Biotechnology”), the company’s wholly-owned subsidiary, passed the drug GMP compliance inspection, indicating that the production base in Lingang, Shanghai (the “Lingang Production Base”) fully met the conditions to formally produce commercial batches of toripalimab. The Lingang Production Base in Shanghai was constructed in accordance with the cGMP standard, with a production capacity of 30,000L in the first phase of the project. By virtue of economies of scale, the expansion of production capacity brought by the Lingang Production Base in Shanghai will enable the Company to gain the advantage of a more competitive production cost.
• Financing activity highlights: In order to optimize the capital structure, focus more on the development of the principal business, improve operating efficiency, increase investment in R&D and better serve technological innovation, Junshi Biosciences has carried out the following financing activities:
  • In June 2021, the company successfully allotted and 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 were approximately RMB2,105 million. The proceeds from the Placing were intended to be used toward the R&D of drugs and pipeline expansion, expansion of the commercialization team, domestic and overseas investment, mergers and acquisitions, and business development, and general corporate purposes.
  • In December 2021, JunTop Biosciences implemented the series A financing, with 14 series A investors subscribing for the new registered capital of JunTop Biosciences at a total consideration of RMB1.275 billion. The proceeds will be used to finance the R&D and production of vaccine and anti-infective drug pipelines of JunTop Biosciences.
  • In March 2022, the Board of Directors approved a proposal to issue about 70 million A Shares to target subscribers under the General Mandate. The proceeds are expected to be approximately RMB3.98 billion, which will be used for R&D projects of innovative drugs and company headquarters and R&D base project. The issuance is still subject to the approval of shareholders of the Company (the “Shareholders”) at the EGM, the approval of the Shanghai Stock Exchange and the approval of registration from the China Securities Regulatory Commission.

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. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for 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 has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (“EUA”) in over 15 countries and regions worldwide. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.

Junshi Biosciences has over 2,800 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

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

Goby Global
Bob Ai
bai@gobyglobal.com
+ 1 646-389-6658

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