On the evening of March 28, Junshi Biosciences (688180.SH/1877.HK) announced its 2023 annual report, with an increase in the quality and efficiency of its annual results. With the landing of toripalimab in the U.S. market, Junshi Biosciences' "going global" story has officially come to an end, and a new chapter of internationalization has opened. In China, the sales of the three major commercial products have accelerated simultaneously, showing that the commercial self-hematopoietic capacity continues to increase. At the same time, R&D has been efficiently promoted, and milestones have been made in the clinical development of a number of core pipelines such as toripalimab and "global new" BTLA monoclonal antibody, accumulating strong growth potential.
According to the annual report, thanks to the rapid growth of three commercial drugs, Junshi Biosciences will achieve revenue of 1.503 billion yuan in 2023. Revenue from pharmaceuticals increased by 58% year-on-year, of which the cumulative sales of the core product toripalimab (Tuoyi ®) increased by 25% year-on-year to RMB919 million.
In a single quarter, in the fourth quarter of 2023, Junshi Biosciences achieved an operating income of 516 million yuan, a quarter-on-quarter increase of about 63%, and the commercialization at home and abroad showed an accelerated momentum.
While the self-hematopoietic ability has been significantly enhanced, Junshi Biosciences has strengthened the control of various project costs, optimized resource allocation, and focused on more potential R&D pipelines, further narrowing the loss margin in 2023, and the net loss attributable to shareholders of listed companies has decreased by 105 million yuan year-on-year, and good results have been achieved in improving the quality and efficiency of operations.
As the first domestic PD-1 monoclonal antibody successfully approved in the United States, toripalimab has made persistent efforts after taking the lead in "going overseas" and has made progress in overseas marketing applications in many countries. At the same time, domestic commercialization is also gradually improving, with the new indication of toripalimab for the perioperative treatment of non-small cell lung cancer (NSCLC) successfully approved for marketing at the end of 2023, and a number of new indications such as triple-negative breast cancer, renal cell carcinoma, and extensive-stage small cell lung cancer have submitted marketing applications, bringing the total number of approved/accepted indications to 10, achieving a simultaneous increase in the depth and breadth of commercialization.
Junshi Biosciences said that on the basis of accelerating the R&D progress and commercialization process of the pipeline under development, it will focus on promoting the data readout of the Phase III registration clinical trial of toripalimab for large indications and leading indications, as well as its global marketing application process, and promote the clinical research and development of globally competitive core products such as the "first-in-class" drug anti-BTLA monoclonal antibody tifcemalimab. In terms of commercialization, we will continue to improve the construction of marketing and commercialization teams, actively explore cooperation with outstanding pharmaceutical companies at home and abroad, and continuously expand the global business territory.
PD-1 set sail to "go to sea" to write a new chapter in the global layout
In October 2023, Junshi Biosciences' marketing application for toripalimab for the treatment of nasopharyngeal carcinoma was approved by the FDA, making it the first and only drug approved for the treatment of nasopharyngeal carcinoma in the United States, and the first innovative biologic drug independently developed and produced in China approved by the FDA.
Junshi Biosciences has created the "China Plan" to fill the clinical gap in the treatment of nasopharyngeal carcinoma in the United States. Just two months after approval, toripalimab was selected as the preferred treatment option in the NCCN guidelines for nasopharyngeal carcinoma.
In January 2024, toripalimab was officially launched into the U.S. market. Judging from the actions of the "going overseas" partners, Coherus regards toripalimab as its core product in both commercialization and clinical layout.
With the landing of toripalimab in the U.S. market, Junshi Biosciences' "going overseas" journey into the world has officially set sail. Up to now, in addition to co-developing the North American market with Coherus, Junshi Biosciences has reached commercialization cooperation with partners such as Hikma, Dr. Reddy's, and Conlianda in more than 50 countries such as the Middle East and North Africa, Latin America, India, South Africa, Southeast Asia, Australia, and New Zealand, and the global commercialization network has basically taken shape.
In the next step, Junshi Biosciences will accelerate the marketing application process of toripalimab in these cooperation regions.
In December 2023 and January 2024, two marketing authorization applications for toripalimab for the treatment of nasopharyngeal carcinoma were submitted through Project Orbis and accepted by the Therapeutic Goods Administration of Australia (TGA) and the Health Sciences Authority of Singapore (HSA), respectively, and received orphan drug designation and priority review designation granted by the TGA.
It is understood that the working framework of the Orbis project allows different regulatory agencies to jointly review the registration application of oncology drugs, and currently 8 regulatory agencies such as the FDA, HSA, and TGA have participated. Toripalimab is the first domestic oncology drug to be included in the Orbis program, and Junshi Biosciences will also explore the possibility of rapid marketing in multiple countries and regions where this pathway is applicable.
In the European market, the marketing authorization applications for the first-line treatment of nasopharyngeal carcinoma and the first-line treatment of esophageal squamous cell carcinoma have been accepted by the European Medicines Agency (EMA) and the Medicines and Healthcare products Agency (MHRA) of the United Kingdom and are under review.
With the smooth deployment of the international layout, Junshi Biosciences will usher in the commercialization of the global market.
Large indications have entered the harvest period to build competitiveness in the field of oncology
While taking the lead in "going overseas" and opening up the space for commercialization and volume, Junshi Biosciences' echelon-like pipeline layout is also promoting its performance to accelerate towards a positive cycle.
In December 2023, toripalimab was approved by the NMPA for the new indication of resectable stage IIIA-IIIB non-small cell lung cancer (NSCLC) for the perioperative treatment of non-small cell lung cancer (NSCLC), becoming the first and only approved perioperative therapy for lung cancer in China.
At the same time, the marketing application of toripalimab for new indications such as advanced triple-negative breast cancer, first-line treatment of advanced renal cell carcinoma, and first-line treatment of extensive-stage small cell lung cancer has been accepted by the NMPA. Due to the leading advantages in the above indications, and the long drug cycle of such indications, Junshi Biosciences is expected to gain a first-mover advantage in market promotion in the future.
To date, toripalimab has submitted a total of 10 marketing applications in China, of which 7 indications have been approved. In addition, the Phase III clinical trial of toripalimab for the first-line treatment of melanoma has met the primary endpoint and will be submitted for sNDA in the near future, and multiple Phase III registrational clinical trials are also in progress.
In the "National Talks" in December 2023, Tuoyi ® (toripalimab) and Humanwei ® (VV116) were successfully included in the 2023 medical insurance catalog. As the only anti-PD-1 monoclonal antibody drug for the treatment of melanoma in the National Medical Insurance Catalog, Tuoyi ®will include a total of 3 new indications in 2023, and a total of 6 indications have been included in the catalog.
In terms of late-stage pipelines, Junshi Biosciences' ongreximab (JS002) is the first drug to obtain clinical trial approval for PCSK9, and its new drug application for the treatment of hypercholesterolemia has been accepted in April 2023 and is expected to be approved for marketing in 2024. Judging from the phase III clinical data presented at the American Heart Association (AHA) meeting in November 2023, angareximab has shown a strong lipid-lowering effect in the treatment of hypercholesterolemia, and is one of the drugs with the fastest clinical progress and the best clinical performance among PCSK9 monoclonal antibodies in China.
As the world's first BTLA monoclonal antibody to enter the clinical development stage, Junshi Biosciences' tifcemalimab has started Phase III registration clinical trials for two indications: limited-stage small cell carcinoma (LC-SCLC) and classical Hodgkin lymphoma (cHL). In addition, a number of Phase Ib/II clinical studies of tifcemalimab in combination with toripalimab are also being conducted simultaneously in China and the United States, and in the clinical trial of toripalimab, tifcemalimab has shown excellent synergistic effect, which can further expand the application and commercialization in more cancer types.
The quality and efficiency of commercialization have increased, and the core technology platform has strengthened innovation support
In terms of operation, with the addition of top talents in the industry, Junshi Biosciences has also continued to optimize the management of the organizational structure of the commercialization team, which has greatly improved the execution and sales efficiency of the commercialization team. In addition, while efficiently promoting the core pipeline, Junshi Biosciences has strengthened the control of various expenses, optimized the allocation of resources, and reduced the overall R&D expenses compared with the previous year, and achieved good results in reducing costs and increasing efficiency.
According to public information, Junshi Biosciences has independently established a technology platform and technological innovation mechanism for the whole industry chain covering macromolecule drugs from early discovery to industrialization, which has greatly improved the level of drug research, further enhanced drug discovery capabilities, and more extensive disease coverage.
With the improvement of commercialization and R&D strength, Junshi Biosciences' technology platform is also improving simultaneously. According to the 2023 annual report, Junshi Biosciences currently has seven core technology platforms, including monoclonal antibodies, bispecific/multi-specific antibodies, antibody drug conjugates (ADCs) R&D platform, and nucleic acid (siRNA) drug R&D platform.
Based on the improvement of the core technology platform and long-term drug development experience, Junshi Biosciences' current innovative R&D areas have also expanded from monoclonal antibody drug types to include small molecule drugs, peptide drugs, antibody drug conjugates (ADCs), bispecific or multispecific antibody drugs, nucleic acid drugs and other types of drug research and development, as well as the exploration of next-generation innovative therapies for cancer and autoimmune diseases. Up to now, Junshi Biosciences' product pipeline covers five major therapeutic areas, including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurological diseases, and infectious diseases.
It is worth mentioning that Junshi Biosciences has made significant progress in the research and development of new drugs in the field of autoimmunity, and has deeply deployed in the world's second largest market for common diseases. At the 2023 American College of Rheumatology Annual Meeting, Junshi Biosciences announced the clinical results of a recombinant humanized anti-IL-17A monoclonal antibody (JS005) for the treatment of patients with moderate to severe psoriasis, significantly improving the area and severity of psoriasis lesions in patients. Up to now, JS005 for the treatment of moderate to severe plaque psoriasis has entered phase III registration clinical trial, which is expected to further cover the therapeutic market for autoimmune diseases.
In addition, based on the evaluation of clinical data and needs, Junshi Biosciences currently focuses on the early R&D pipelines such as Claudin18.2 ADC drug (JS107), PI3K-α oral small molecule inhibitor (JS105), ANGPTL3-targeting siRNA drug (JS401), anti-CGRP monoclonal antibody (JS010), and PD-1 subcutaneous injection formulation (JS001sc), which is expected to bring continuous growth momentum to Junshi Biosciences.
The above content and data have nothing to do with the position of the interface and do not constitute investment advice. Do so at your own risk.