Two Ivonescimab (PD-1/VEGF) results, including phase 3 monotherapy versus pembrolizumab monotherapy in first-line treatment of PD-L1-positive NSCLC, to be presented at WCLC 2024

• First launch of Part III head-to-head medical examine information Ivonescimab versus Pembrolizumab within the remedy of NSCLC
  
• Ivonescimab is the primary drug to realize medical significance over pembrolizumab in a randomized section III medical trial in NSCLC

Hongkong, August 11, 2024 /PRNewswire/—— Kangfang Know-how Co., Ltd. (HKEX code: 9926.HK) (“it is coming,”) at this time introduced that two oral displays of ivonescimab (PD-1/VEGF bispecific antibody) shall be held at IASLC 2024 World Convention on Lung Most cancers Sponsored by the Worldwide Consortium for the Research of Lung Most cancers (“WCLC24”), San Diego, USA from September 7-10, 2024. One of many newest presidential symposium displays offered outcomes from the HARMONi-2/AK112-303 examine, which evaluated monotherapy ivonescimab versus ivonescimab in sufferers with tumor-positive regionally superior or metastatic non-small cell lung most cancers (NSCLC). Efficacy of monotherapy with pembrolizumab.

The most recent outcomes of HARMONi-2/AK112-303 shall be launched by Professor Zhou Caicun, chief researcher of HARMONi-2 and director of the State Key Laboratory. Medical Oncology exist Shanghai Pulmonary Hospital, Tongji College.

Lectures throughout WCLC 2024

it is coming We may even take part as an exhibitor and actively work together with professionals in several fields.

Milestones for ivonescimab:

Might 2024:
Ivonescimab receives advertising authorization for the remedy of regionally superior or metastatic non-squamous non-small cell lung most cancers (“nsq-NSCLC”) with epidermal development issue receptor (“EGFR”) mutations, making it the world’s first authorised PD -1/ VEGF bispecific antibody.

Might 31:
In a prespecified interim evaluation carried out by the Unbiased Information Monitoring Committee, the Blinded Unbiased Committee on Radiology Evaluate (BICR) confirmed that ivonescimab supplied a statistically important and clinically significant enchancment in PFS in contrast with pembrolizumab with out threat Ratio (HR) considerably higher than anticipated. There are at the moment no recognized section III medical trials in NSCLC which have proven statistically important enchancment in contrast with pembrolizumab in a head-to-head setting.

June 01:
Interim outcomes from the Part III examine of ivonescimab mixed with platinum-doublet chemotherapy in sufferers with EGFR-mutated non-squamous NSCLC who progressed on EGFR-TKIs (HARMONi-A) to be introduced in 2024 American Society of Scientific Oncology (ASCO) annual assembly, this examine was rated as a high report on the ASCO lung most cancers TOP 10 checklist by OncoAlert, a world most cancers assist group. On the identical day, the analysis outcomes had been additionally printed within the journal “JAMA”.

July 25:
Concorso’s accomplice, Summit Therapeutics (NASDAQ: ) Inc. (Nasdaq: SMMT) (the “Summit”) introduced that it’s going to College of Texas MD Anderson Most cancers Heart (MD Anderson) is designed to hurry the event of sure sorts of renal cell carcinoma, colorectal most cancers, pores and skin most cancers, and breast most cancers.

July 29:
The supplemental new drug software (sNDA) for ivonescimab as first-line remedy of PD-L1-positive (PD-L1 TPS ≤1%) regionally superior or metastatic non-small cell lung most cancers (NSCLC) has been accepted by State Drug Administration (Nationwide Medical Merchandise Administration). This new indication software for ivonescimab relies on the HARMONi-2 (AK112-303) examine.

August 02:
The supplemental new drug software (sNDA) of ivonescimab monotherapy for the first-line remedy of PD-L1-positive (PD-L1 TPS ≥ 1%) regionally superior or metastatic NSCLC has been accepted for precedence evaluate by China NMPA.

About Ivonescimab (AK112/SMT112)
Ivonescimab is the world’s first new PD-1/VEGF bispecific immunotherapy drug independently developed by the corporate. it is coming. Ivonescimab is called SMT112 in the USA summit remedy inc. Licensed areas embody USA, Canada, Europe, Japan, Central America, South Americathis center East and Africa. Ivonescimab was authorised by the NMPA for the remedy of sufferers with EGFR-mutated regionally superior or metastatic non-squamous NSCLC whose illness has progressed after EGFR TKI remedy. Presently, the primary indication of ivonescimab has been authorised Chinaand it is coming 5 section III trials are ongoing, together with 2 international MRCTs and 4 registration trials concentrating on anti-PD-1 therapies. The corporate can also be conducting a number of medical trials of ivonescimab, protecting 16 indications corresponding to gastrointestinal most cancers, hepatocellular carcinoma, and colorectal most cancers.

about it is coming
it is coming (Hong Kong Inventory Change: 9926.HK) is a number one biopharmaceutical firm devoted to the analysis, improvement, manufacturing and commercialization of the world’s first or best-in-class progressive biopharmaceuticals. Based in 2012, the corporate has created a singular built-in R&D innovation system with a complete end-to-end drug improvement platform (ACE Platform) and bispecific antibody drug improvement know-how (Tetrabody) because the core. The GMP-compliant manufacturing system has superior commercialization system of its working mannequin, and progressively developed right into a globally aggressive biopharmaceutical firm specializing in progressive options.

With a totally built-in, versatile platform, it is coming The corporate is growing greater than 50 progressive belongings internally, protecting main illness areas corresponding to most cancers, autoimmune illnesses, irritation, metabolic illnesses, and so forth., and has 19 drug candidates in medical levels, together with 8 multi-specific antibodies. it is coming Efficiently promoted the commercialization of three progressive organic medicine, and submitted advertising functions for 4 new medicine for a number of indications. å®å°¡ August 2021is at the moment the one differentiated PD-1 monoclonal antibody of IgG1 subtype that makes use of Fc-null area modification. ® (PD-1/CTLA-4 bispecific antibody cardonilimab injection) was authorised for advertising in 2017 June 2022turning into the world’s first bispecific antibody drug for tumor immunotherapy and the primary new bispecific antibody drug in China. Might 2024® (PD-1/VEGF bispecific antibody, ivonezumab injection), is the world’s first PD-1/VEGF bispecific antibody independently developed by our firm it is comingAdvertising authorization for the remedy of regionally superior or metastatic non-squamous non-small cell lung most cancers (“nsq-NSCLC”) with epidermal development issue receptor (“EGFR”) mutations, making it the world’s first authorised PD-1 /VEGF bispecific antibody. The drug has been granted three breakthrough remedy designations by the FDA for the remedy of lung most cancers Drug Analysis Heart (CDE). exist December 2022a licensing settlement with a complete potential transaction worth of US$ US$5 billionCoupled with the double-digit low product web gross sales royalties in new drug licensing nations, it set a brand new file for the abroad licensing transaction quantity of a single progressive drug in 2019. China.

By way of high-efficiency and breakthrough R&D innovation, it is coming We at all times combine international superior assets, develop first-class, best-in-class new medicine, present inexpensive therapeutic antibodies to sufferers world wide, proceed to create extra business and social worth, and turn out to be the world’s main biopharmaceutical firm.