On March 30, 2021 Junshi Biosciences, a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported financial results for the full year 2020 and provided corporate updates (Press release, Shanghai Junshi Bioscience, MAR 30, 2021, View Source [SID1234633504]).
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Full Year 2020 Financial Highlights
Total revenues increased 106% to RMB1,595 million for the full year ended December 31, 2020. Sales of toripalimab reached RMB1,003 million with gross profit margin of 89%. Additional revenues included out-licensing revenue of RMB405 million and research collaboration service revenue of RMB 88 mil.
The research and development ("R&D") expenses were RMB1,778 million for the full year ended December 31, 2020, representing an increase of 88% from the same period in 2019. The increase was primarily due to continued increasing investment in in-house projects and more R&D collaboration and license-in activities. The R&D fields of the Company have expanded from monoclonal antibodies to more drug types, including small molecule drugs, antibody drug conjugates (ADCs), bifunctional fusion proteins and cell therapies, as well as the exploration of next-generation innovative therapies for cancer and autoimmune diseases.
Net cash from financing activities was RMB4,414 million for the full year ended December 31, 2020, which was mainly attributable to the successful new issuance of A shares on the STAR Market of the Shanghai Stock Exchange (the "STAR Market") with RMB4,497 million through the initial public offering on 15 July 2020.
Total comprehensive expense was RMB1,688 million for the full year ended December 31, 220, representing an increase of 128% compared to the year 2019, which was mainly attributable to the revenue from sales of toripalimab, revenue from out-licensing and service income but offset by the increasing R&D expenses, administrative expenses and selling and distribution expenses.
Cash and cash equivalents as of December 31, 2020 were RMB3,385 million compared to RMB1,214 million as of December 31, 2019. The increase mainly came from funds raised from the listing of the Company’s A shares on the STAR Market on 15 July 2020.
Business Highlights
During the full year ended December 31, 2020, we have achieved significant progress with respect to our product commercialization, clinical trials, pipeline expansion and construction of production bases, including:
Toripalimab was successfully included in the new catalogue of the National Reimbursement Drug List upon negotiations, which will further enhance the domestic affordability and accessibility of the drug.
The supplemental new drug application ("NDA") for toripalimab received a second conditional approval for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of prior systemic therapy.
Toripalimab has been granted 1 breakthrough therapy designation, 1 fast track designation and 3 orphan-drug designations by the U.S. Food and Drug Administration (the "FDA") for the treatment of mucosal melanoma, nasopharyngeal carcinoma and soft tissue sarcoma, and has been included in the Drug List of the Procedure for Breakthrough Therapy Designation by the National Medical Products Administration (the "NMPA"). The supplemental NDA of toripalimab for the second-line treatment of metastatic urothelial carcinoma received priority review from the NMPA in July 2020. With accelerated clinical trials domestically and abroad, more than 30 clinical studies covering more than 15 indications in respect of toripalimab have been conducted globally, including in China and the United States.
In September 2020, the Independent Data Monitoring Committee (the "IDMC) determined that toripalimab in combination with standard chemotherapy as the treatment for patients with recurrent or metastatic nasopharyngeal carcinoma met its pre-specified primary endpoint at the interim analysis of a randomized, double-blind, placebo-controlled, international multi-center, Phase III clinical study. In February 2021, the supplemental NDA of toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA.
In December 2020, the IDMC determined that toripalimab in combination with standard chemotherapy as the first-line treatment of patients with advanced non-small cell lung cancer met its pre-specified primary endpoint at the interim analysis of a randomized, double-blind, multi-center, phase III clinical study.
As of the date of this announcement, we have 30 drug candidates, including 28 innovative drugs and 2 biosimilars, covering 5 major therapeutic areas including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurological diseases and infectious diseases.
TAB004/JS004 (recombinant humanized anti-BTLA monoclonal antibody injection) was approved for clinical trials in China by the NMPA in January 2020, and the dosing of the first patient was completed in the Phase I clinical trial in April 2020. In addition, it has completed the dose-escalation stage in Phase I in the U.S. and entered the dose-expansion stage.
JS005 (recombinant humanized anti-IL-17A monoclonal antibody for injection) completed the dosing of the first subject in the Phase I clinical trial which was conducted in China in May 2020. At present, the Phase I clinical study has been completed and the Phase II clinical trial is underway.
JS108 (recombinant humanized anti-Trop2 monoclonal antibody -Tub196 conjugate) was approved for clinical trials in China by the NMPA in July 2020 and completed the dosing of the first patient in November 2020.
TAB006/JS006 (specific anti-TIGIT monoclonal antibody injection) obtained the clinical trial approval from the NMPA and the FDA in November 2020 and February 2021, respectively.
Entered the field of anti-infection treatment and worked together to fight the pandemic. At the beginning of the outbreak, we quickly launched a neutralizing antibody R&D project (generic name: etesevimab; project code: JS016) with the Institute of Microbiology, Chinese Academy of Sciences ("IMCAS") for the treatment and prevention of the novel coronavirus disease ("COVID-19") in order to combat the pandemic.
In May 2020, the Company and Eli Lilly and Company entered into an agreement to collaborate on the research, development and commercialization of potential preventive and therapeutic antibody therapies for COVID-19, and Lilly was granted an exclusive license to conduct research, develop and commercialize JS016 outside Greater China.
The international authoritative journal, Nature, published the results of etesevimab pre-clinical research, which reported for the first time that the neutralizing antibody of SARS-CoV-2 can significantly inhibit COVID-19 infection in the test on non-human primate rhesus monkeys, showing the dual effect of treatment and prevention with a value for conversion into clinical practices.
As of the date of this announcement, we have completed a Phase I study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of etesevimab among healthy Chinese subjects, and initiated international multi-center Phase Ib/II trials among COVID-19 patients.
The FDA granted Lilly, our partner, the Emergency Use Authorization for investigational etesevimab 1,400 mg and bamlanivimab 700 mg together, for the treatment of mild to moderate COVID-19 in patients who were at high risk for progressing to severe COVID-19 and/or hospitalization.
The National Institutes of Health (NIH) in the United States recommended the use of etesevimab and bamlanivimab together for the treatment of mild to moderate COVID-19 outpatients with a higher risk of clinical progression in its recently updated "COVID-19 Treatment Guidelines".
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive scientific opinion, for etesevimab administered together with bamlanivimab.
Broadened the layout of product pipeline through co-development/license-in 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 and broaden the layout of drug combination therapies.
We entered into a research collaboration and license agreement with Revitope Oncology, Inc. and its wholly-owned subsidiary Revitope Limited. The parties will collaborate in the R&D of the next-generation of T-cell engaging cancer immunotherapies that utilize Revitope’s Precision GATETM Technology Platform together with the Company’s antibody technology platforms.
By forming a company jointly with IMPACT Therapeutics, Inc., we collaborated in the development of senaparib, a PARP inhibitor, and own 50% of its interests within mainland China, the Hong Kong Special Administrative Regions ("Hong Kong") and the Macau Special Administrative Regions ("Macau"). Both parties will collaborate in conducting clinical trials, manufacturing, and commercializing preparations for various indications of senaparib within the above-mentioned collaboration territory.
We entered into a shareholders collaboration agreement with Beijing Eirene Biotech Co., Ltd. for the formation of a joint venture company mainly engaged in the R&D, clinical application and market development of the CD39 drug. The CD39 product has a unique and innovative design concept to achieve high efficacy and reduce potential systemic adverse effects by selectively targeting the immune suppressive cells with high CD39 expression in the tumor microenvironment. The joint venture company will be owned 50% by the Company and 50% by Beijing Eirene upon its formation.
We entered into a collaboration agreement with Wigen Biomedicine Technology (Shanghai) Co., Ltd. ("Wigen Biomedicine") for the world-wide joint development, production and commercialization of four of Wigen Biomedicine’s anti-tumor small molecule drug candidates (XPO1 inhibitor, Aurora-A inhibitor, EGFR-exon20 inhibitor and fourth-generation EGFR inhibitor).
All these collaborations will broaden and strengthen our product layout in the oncology field to cover more tumor types, in the hopes of providing more treatment options for tumor patients in China and abroad in the future.
In order to optimize the capital structure, focus more on the development of the principal business, improve operating efficiency, increase our investment in research and development, and better serve technological innovation, we made every effort to prepare for the listing of the Company’s A shares on the STAR Market which were successfully listed on the STAR Market on 15 July 2020.