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SHANGHAI, Aug. 30, 2024 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a number one innovation-driven biopharmaceutical firm devoted to the invention, improvement, and commercialization of novel therapies, introduced its 2024 interim monetary outcomes and supplied company updates.
FINANCIAL HIGHLIGHTS
- As of June 30, 2024, the overall income of Junshi Biosciences was roughly RMB786 million through the first half of 2024, representing a rise of roughly 17% in comparison with 2023. The expansion was primarily because of the roughly 11% improve in income from pharmaceutical merchandise in comparison with 2023. Particularly, the home gross sales income of our core product, TUOYI® (toripalimab), reached roughly RMB671 million, representing a rise of roughly 50% in comparison with 2023.
- Complete analysis and improvement (“R&D”) bills had been roughly RMB546 million for the primary half of 2024, representing a lower of roughly 42% in comparison with 2023. The lower in R&D bills was primarily because of the firm’s value management coverage, efforts to optimize useful resource allocation and concentrate on R&D pipelines with higher potential. As well as, a number of medical trials for our core product, TUOYI®, successively met their main endpoints, contributing to the pure decline of R&D expenditure.
- Loss attributable to homeowners of the corporate decreased to RMB646 million for the primary half of 2024, representing a lower of roughly RMB351 million or roughly 35% in comparison with 2023.
- As of June 30, 2024, the corporate’s mixture steadiness of financial institution balances, money and monetary merchandise was roughly RMB3,311 million, a slight lower of RMB467 million in comparison with the steadiness on the finish of 2023, which ensured our comparatively ample money place to assist the corporate’s improvement.
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BUSINESS HIGHLIGHTS
Throughout the first half of 2024, we centered on addressing “unmet medical wants”. Now we have made authentic, revolutionary and breakthrough progress within the discovery, R&D and commercialization of revolutionary therapies and novel medicine with accelerating worldwide improvement. The next achievements and milestones had been reached:
- Developments within the pipeline: the corporate’s revolutionary R&D subject has expanded past monoclonal antibodies to a wider vary of drug modalities, together with small molecules medicine, polypeptide medicine, antibody-drug conjugates (ADCs), bi-specific or multi-specific antibodies and nucleic acid medicine. The corporate can be exploring next-generation revolutionary therapies together with most cancers and autoimmune illnesses. The product pipelines cowl 5 main therapeutic areas, together with malignant tumors, autoimmune illnesses, continual metabolic illnesses, neurologic illnesses and infectious illnesses. A complete of three medicine (TUOYI®, JUNMAIKANG and MINDEWEI) are at the moment in the marketplace, round 30 belongings are present process medical trials, and over 20 drug candidates are on the pre-clinical drug improvement stage.
- In January 2024, the Nationwide Drug Listing for Fundamental Medical Insurance coverage, Work-Associated Harm Insurance coverage and Maternity Insurance coverage (12 months 2023) (the “NRDL”) was formally applied. Junshi Biosciences has three medicine included within the latest version of the NRDL. Notably, 3 new TUOYI® indications have been included: first-line therapy of nasopharyngeal carcinoma (“NPC”), first-line therapy of esophageal squamous cell carcinoma (“ESCC”) and first-line therapy of non-squamous non-small cell lung most cancers (“NSCLC”), bringing the present variety of indications within the NRDL to a complete of 6. MINDEWEI’s indication for grownup sufferers with gentle to average coronavirus illness 2019 (“COVID-19”) was formally included within the NRDL for the primary time. All eight authorized indications of JUNMAIKANG stay within the NRDL.
- In January 2024, Coherus BioSciences, Inc. (“Coherus”), a associate of the corporate, introduced that toripalimab was obtainable for entry and administration in the US. Previous to that, toripalimab (U.S. commerce title: LOQTORZI®) was authorized for advertising and marketing by the U.S. Meals and Drug Administration (the “FDA”) in October 2023, and have become the primary revolutionary organic drug from China included as a most well-liked therapy choice within the NPC pointers of the Nationwide Complete Most cancers Community (“NCCN”) in December 2023.
- In January 2024, the Singapore Well being Sciences Authority (the “HSA”) accepted the brand new drug utility (the “NDA”) for toripalimab together with cisplatin and gemcitabine for the first-line therapy of adults with metastatic or recurrent regionally superior NPC, and for toripalimab as a single agent for the therapy of adults with recurrent, unresectable, or metastatic NPC with illness development on or after platinum-containing chemotherapy.
- In April 2024, the Japanese Prescribed drugs and Medical Gadgets Company (the “PMDA”) authorized the corporate’s initiation of a randomized, double-blind, placebo-controlled, worldwide multi-regional section III medical examine of tifcemalimab (a recombinant humanized anti-BTLA monoclonal antibody, code: TAB004/JS004) together with toripalimab as consolidation remedy in sufferers with limited-stage small cell lung most cancers (“LS-SCLC”) with out illness development following chemo-radiotherapy.
- In April 2024, two supplemental new drug purposes (the “sNDA”) for ongericimab (a recombinant humanized anti-PCSK9 monoclonal antibody, code: JS002) had been accepted by the Nationwide Medical Merchandise Administration of China (the “NMPA”).
- In April 2024, the NMPA authorized the sNDA for TUOYI® together with axitinib for the first-line therapy of sufferers with medium to excessive danger unresectable or metastatic renal cell carcinoma (“RCC”). This was the primary authorized immunotherapy for renal carcinoma in China.
- In April 2024, the NDA for toripalimab together with cisplatin and gemcitabine for the first-line therapy of adults with metastatic or recurrent regionally superior NPC, and for toripalimab as a single agent for the therapy of adults with recurrent, unresectable, or metastatic NPC with illness development on or after platinum-containing chemotherapy was accepted by the Drug Workplace, Division of Well being, the Authorities of the Hong Kong Particular Administration Area (the “DO”).
- In June 2024, the first endpoints of progression-free survival (“PFS”, based mostly on unbiased radiographic assessment) and total survival (“OS”) of a multi-center, randomized, open-label, energetic managed section III medical examine (the “HEPATORCH examine”, NCT04723004) of TUOYI® together with bevacizumab for the first-line therapy of superior hepatocellular carcinoma (“HCC”) met the pre-defined efficacy boundary, and the sNDA was accepted by the NMPA in July 2024.
- In June 2024, the NMPA authorized the sNDA for TUOYI® together with etoposidein plus platinum because the first-line therapy of extensive-stage small cell lung most cancers (“ES-SCLC”).
- In June 2024, the NMPA authorized the sNDA for TUOYI® together with paclitaxel for injection (albumin-bound) for the first-line therapy of recurrent or metastatic triple-negative breast most cancers (“TNBC”) with a well-validated take a look at to guage PD-L1 optimistic (CPS≥1). This was the tenth indication of toripalimab authorized within the Chinese language mainland.
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- Enterprise operations
- As of the tip of the primary half of 2024, Junshi Biosciences accomplished the Good Manufacturing Apply (“GMP”) and Good Medical Apply inspections of the European Union (the “EU”). At present, the European Fee (the “EC”) is reviewing the advertising and marketing authorization purposes (the “MAA”) for toripalimab for the first-line therapy of NPC and ESCC.
- In June 2024, the corporate convened the 2023 annual common assembly, the 2024 top quality assembly of A shareholders and the 2024 top quality assembly of H shareholders, and accomplished the election for the fourth session of the Board of Administrators and the Board of Supervisors.
About Junshi Biosciences
Based in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical firm devoted to the invention, improvement and commercialization of revolutionary therapeutics. The corporate has established a diversified R&D pipeline comprising over 50 drug candidates, with 5 therapeutic focus areas protecting most cancers, autoimmune, metabolic, neurological, and infectious illnesses. 4 of the corporate’s improvements have already reached the Chinese language or worldwide markets, one in every of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, authorized in China and the US. Moreover, greater than 30 medicine are at the moment in medical improvement. Throughout the COVID-19 pandemic, Junshi Biosciences actively shouldered the social duties of a Chinese language pharmaceutical firm by way of its involvement in growing etesevimab, MINDEWEI®, and different novel therapies for the prevention and therapy of COVID-19.
With a mission of “offering sufferers with world-class, reliable, inexpensive, and revolutionary medicine,” Junshi Biosciences is “In China, For International.” At current, the corporate boasts roughly 2,500 staff in the US (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, and so on.). For extra data, please go to: http://junshipharma.com.
Junshi Biosciences Contact Data
IR Staff:
Junshi Biosciences
data@junshipharma.com
+ 86 021-6105 8800
PR Staff:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800
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