Junshi Biosciences Reports H1 2019 Results: Core Product Toripalimab Generates Over RMB 300 Million in Sales
Junshi Biosciences
Innovative Drug Developer
On August 29, Junshi Biosciences (NEEQ: 833330, HKEX: 01877) announced its interim results for 2019, highlighting key achievements in financial performance and business progress during the first half of the year.
In the first half of 2019, Junshi Biosciences achieved significant milestones in corporate operations, R&D pipeline expansion, clinical trial advancement, capacity enhancement, and commercial promotion of launched products, with all business segments experiencing rapid and healthy growth. Its independently developed anti-PD-1 monoclonal antibody, Tuoyi (toripalimab), was rolled out for nationwide sales across China by the end of February. While bringing hope to tens of thousands of cancer patients, the company is further validating the safety and efficacy of Tuoyi in treating various tumor types, thereby expanding the population of benefiting patients. As of June 30, Junshi Biosciences had initiated 11 Phase II or III clinical trials covering indications such as nasopharyngeal carcinoma, urothelial carcinoma, melanoma, non-small cell lung cancer, triple-negative breast cancer, esophageal cancer, and hepatocellular carcinoma.
Driven by the development of its core “source innovation” platform and through collaborations with innovative pharmaceutical companies both domestically and internationally, Junshi Biosciences has expanded its R&D pipeline to include 19 drug candidates in development. Among these, JS004/TAB004 (a BTLA monoclonal antibody) has entered Phase I clinical trials after receiving Investigational New Drug (IND) approval from the U.S. FDA in April; JS005 (an IL-17A monoclonal antibody) has recently obtained clinical trial approval from China’s National Medical Products Administration (NMPA).
In terms of production capacity expansion, Junshi Biosciences’ Suzhou Wujiang manufacturing base has completed its upgrade, achieving a commercial production capacity of 3,000 liters. The Shanghai Lingang manufacturing base is expected to commence production and validation of products under development in the second half of this year. The combined total capacity of 33,000 liters from the two manufacturing bases will provide ample support for growing commercial production and clinical trial demands, driving the company’s sustained growth.
In addition, Junshi Biosciences is applying for a listing on the STAR Market of the Shanghai Stock Exchange and submitted filing materials for pre-listing tutoring to the Shanghai Regulatory Bureau of the China Securities Regulatory Commission on April 25, 2019. In light of the Company’s current situation and future development strategy, this issuance of A-shares will further broaden its financing channels, improve corporate governance, accelerate the industrialization of drugs under development, and play a positive role in maintaining the Company’s leading position in the industry.
Financial Summary
As of June 30, 2019, the Company achieved total sales revenue of RMB 309 million. Its core product, Tuoyi, generated sales revenue of RMB 308 million, with a gross profit margin of 87%. Sales expenses accounted for approximately 36% of sales revenue. Both metrics are at or above the industry average. A healthy revenue structure helps the Company better support its R&D investment.
In terms of R&D, the company’s R&D expenditure reached RMB 369 million, a year-on-year increase of 69%. The company will continue to invest in R&D and has already made significant progress in several key clinical trials.
Furthermore, driven by the commercialization of Tuoyi at the beginning of the year, the Company incurred sales and distribution expenses of RMB 110 million in the first half of the year. Due to investments in the construction of the Lingang production base, the net cash used in investing activities amounted to RMB 437 million. Upon completion and commencement of operations, the base will significantly enhance the Company’s existing production capacity.
Performance Highlights
In the first half of 2019, leveraging its independently developed core platform and collaborations with third parties, Junshi Biosciences expanded its product pipeline to 19 drug candidates in development. These candidates cover multiple disease areas with significant unmet medical needs, including 13 oncology drugs, 2 metabolic disease drugs, 3 drugs for inflammatory or autoimmune diseases, and 1 drug for neurological disorders.
Progress of Junshi Biosciences' R&D Pipeline
JS001 (Anti-PD-1 Monoclonal Antibody)
Toripalimab (trade name: Tuoyi) is the Company’s first commercialized product. It received conditional marketing approval from the NMPA on December 17, 2018, for second-line treatment of unresectable or metastatic melanoma in patients who have failed prior systemic therapy, and nationwide sales in China commenced in late February this year.
In the first half of the year, Junshi Biosciences conducted 11 Phase II/III pivotal clinical trials of toripalimab as monotherapy or in combination with standard therapy for advanced melanoma, advanced esophageal cancer, adjuvant treatment of advanced hepatocellular carcinoma, non-small cell lung cancer, advanced nasopharyngeal carcinoma, and advanced urothelial carcinoma:
In June, at the American Society of Clinical Oncology (ASCO) Annual Meeting, Chinese researchers presented the interim analysis of the pivotal Phase II trial of toripalimab in nasopharyngeal carcinoma, the preliminary results of the pivotal Phase II trial in urothelial carcinoma, and two analyses from Phase II trials in solid tumors (gastric cancer and esophageal squamous cell carcinoma), in the form of posters or poster discussions.
In August, the clinical results (open-label Phase Ib) of Tuoyi combined with axitinib in patients with metastatic mucosal melanoma were published in the Journal of Clinical Oncology (IF: 28.245);
In September, the study on Tuoyi combined with chemotherapy for the treatment of patients with EGFR-positive advanced NSCLC will be presented as an oral presentation at the 2019 World Conference on Lung Cancer.
The Phase Ia clinical trial conducted in the United States has been completed, while the Phase Ib trial is ongoing.
Collaborate with more innovative pharmaceutical companies domestically and internationally to further explore the efficacy and safety of toripalimab in combination therapies:
In January, the National Medical Products Administration (NMPA) approved the clinical trial application for the combination of toripalimab and Betta Pharmaceuticals’ vorolanib (CM082). CM082 is a multi-target receptor tyrosine kinase (RTK) inhibitor targeting VEGFR and PDGFR, which can inhibit angiogenesis and tumor growth while overcoming the high toxicity commonly associated with similar targeted therapies.
In February, a clinical study was proposed to evaluate the combination of toripalimab and donafenib tosylate (CM4307) from Zeltzer Biopharma for the treatment of advanced hepatocellular carcinoma. CM4307 is a Class 1 novel chemical drug and a multi-target kinase inhibitor with dual anti-tumor effects.
In April, toripalimab and Ascentage Pharma’s IAP inhibitor are planned to undergo combination therapy clinical trials in mainland China, with the collaboration covering solid tumors and hematologic malignancies, particularly refractory cancers, drug-resistant tumors, and other indications in China;
In July, toripalimab and Sinovant’s XNW7201 are planned to initiate a clinical study of combination therapy in mainland China for the treatment of gastrointestinal tumors (including esophageal cancer, gastric cancer, and colorectal cancer).
The commercial promotion department employs nearly 300 staff members, most of whom come from the oncology departments of well-known companies both domestically and internationally.
Progress of Key Clinical Trials for Tuoyi
UBP1211 (Anti-TNF-α Monoclonal Antibody, Adalimumab Biosimilar)）
TNF-α-targeting monoclonal antibody drug, the company's first biosimilar, is primarily used for the treatment of various autoimmune diseases, including rheumatoid arthritis and ankylosing spondylitis:
Phase I and Phase III clinical trials have been completed. The Phase III clinical results demonstrated that UBP1211 is equivalent to Humira in terms of pharmacokinetics and efficacy, with a similar safety profile;
The company is about to submit its NDA.
JS002 (Anti-PCSK9 Monoclonal Antibody)
The first anti-PCSK9 monoclonal antibody approved by the NMPA in China for clinical trials in the treatment of hyperlipidemia:
Phase I clinical trials have been completed in healthy volunteers, and Phase II clinical trials are currently underway in patients with hyperlipidemia;
Preparations for Phase III clinical trials in a broader patient population have been initiated;
According to clinical study data, JS002 demonstrated satisfactory safety and tolerability. In terms of LDL-C reduction, JS002 showed similar lipid-lowering efficacy but a longer duration of action compared to products targeting the same mechanism.
JS004/TAB004 (BTLA Monoclonal Antibody)
The world’s first anti-BTLA blocking antibody for tumor treatment, intended for the treatment of advanced unresectable or metastatic solid tumors:
JS005 (IL-17A Monoclonal Antibody)
Pleiotropic cytokines that can be used to alleviate the symptoms of autoimmune diseases, such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis:
In June, the clinical trial application was accepted by the NMPA;
In August, the “Notice of Approval for Drug Clinical Trials” issued by the NMPA was obtained.
Other Products
In February, the Company entered into a technology transfer and collaboration agreement with Runjia Pharmaceuticals, pursuant to which Runjia Pharmaceuticals agreed to transfer a 50% equity interest in each of two inhibitor projects (a pan-CDK inhibitor and a PI3K inhibitor).
In June, the Company entered into a Share Purchase Agreement with Anwita Biosciences. Concurrently, a License Agreement was executed to develop and commercialize the innovative IL-21 fusion protein AWT008 in the Greater China region (including Mainland China, Taiwan, Macau, and Hong Kong). IL-21 is an active cytokine that stimulates the activation of innate and adaptive immune cells, such as natural killer (NK) cells and cytotoxic T cells;
In June, the Company entered into a Technology Transfer and Collaboration Agreement with Huaotai Bio, pursuant to which the Company agreed to purchase from Huaotai Bio the existing R&D achievements and subsequent technical support for HOT-1010, a biosimilar of Avastin. HOT-1010 is a recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody injection.
Junshi Biosciences Reveals in Its Mid-Year Report That It Will Accelerate Drug R&D and Commercialization, Including Trials of Toripalimab for Multiple Tumor Indications in China and International Multicenter Clinical Trials in the United States and Other Countries, While Prioritizing IND Applications and Clinical Trials for First-in-Class Drugs.
Furthermore, Junshi Biosciences will continue to expand its product pipeline by exploring new drug targets in the small-molecule field, developing and fostering collaborations with leading small-molecule pharmaceutical companies, while simultaneously advancing the tracking and exploratory research of potential targets suitable for large-molecule therapeutics.
Building a World-Class Production System: Capacity Expansion + Quality First
In the first half of 2019, the production base in Wujiang, Suzhou, completed its capacity upgrade, expanding commercial manufacturing capacity from three 500-L fermentation tanks to six. In addition, Junshi Biosciences has completed the installation of key equipment at its Shanghai Lingang production base, with production and validation of products under development expected to commence in the second half of this year.
The aforementioned expansion will increase Junshi Biosciences’ total production capacity to 33,000 liters and provide additional capacity to support commercial manufacturing and clinical trials. It is believed that these two production bases will ensure ample capacity for the Company, thereby driving its growth.
While expanding production capacity, Junshi Biosciences regards drug quality as its lifeline. In August, the company appointed Dr. Wang Gang as Senior Vice President of Industrial Affairs and Chief Quality Officer. With over three decades of experience in the pharmaceutical industry, Dr. Wang has more than 20 years of expertise in biologics cGMP (Current Good Manufacturing Practice) and regulatory affairs, including the review, manufacturing, pre-approval inspections, and cGMP compliance inspections of biological products such as cell and gene therapies. He will lead the team in establishing a production quality management system with international standards to meet the company’s growing production capacity needs and expansion into global markets.