Biotech Top 50 Firms — Akeso, Meta Pharmaceuticals, South China Vaccines, and iView Therapeutics Report Recent Clinical and Regulatory Progress

"Weekly Corporate News"

Recently,Top 50 Biotech Innovation Companies – Akeso (9926.HK) announced that the first patient has been enrolled in the U.S. for a randomized, double-blind, placebo-controlled, international multi-center Phase II clinical trial of its self-developed next-generation CD47 monoclonal antibody Lifarli (AK117) in combination with Azacitidine (AZA) for the treatment of newly diagnosed higher-risk myelodysplastic syndromes (MDS).

Akeso (9926.HK) is a leading company that integrates the research, development, production, and commercialization of globally pioneering or best-in-class innovative biologics. Since its establishment in 2012, the company has built its unique end-to-end Akeso Comprehensive New Drug R&D Platform (ACE Platform), established an innovation-driven R&D system centered on Tetrabody bispecific antibody technology, Antibody-Drug Conjugate (ADC) technology, mRNA technology, and cell therapy technology, along with a GMP production system meeting international standards and an advanced commercial operation model, making it a competitive biopharmaceutical innovator on a global scale.

，Top 50 Emerging Biotech Innovation Companies –META(META Pharmaceuticals Inc.) announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to its investigational new drug META-001-PH.(Rare Pediatric Disease Designation, RPDD), for the treatment of Primary Hyperoxaluria (PH).

META Pharmaceuticals Inc. is an innovative pharmaceutical company dedicated to the research and development of drugs for autoimmune and metabolic diseases. Based on cutting-edge emerging biological theories, it aims to effectively regulate immune system functions and other physiological system functions by modulating cellular metabolic activity, developing safer and more effective treatments for autoimmune and metabolic diseases. The company focuses on the research and development of first-in-class novel drugs, providing urgently needed medications for patients worldwide. META has received numerous honors and certifications, including being ranked among the Top 10 Most Growth-Oriented Small Molecule Innovative Enterprises in China's Biotech Innovation Value List 2022, the Top 50 High-Growth Enterprises in the Greater Bay Area (GBA) 2022, the Top 50 Biotech Innovation Enterprises in the GBA 2023, the KPMG China Biotech Innovation Top 50 Enterprises 2023, one of the top five national finalists in the 2023 Novo Nordisk Star Start Innovation Competition, and was invited to attend the JPM Healthcare Conference 2024.

The clinical trial application for the quadrivalent influenza recombinant protein vaccine developed by South China Vaccine, a potential enterprise in the Top 50 Biotech Innovation Companies of the second edition, has been accepted by the CDE.This vaccine is a globally pioneering innovative vaccine that combines recombinant influenza protein antigen (insect cell sf9) with CD-A adjuvant. It differs from the already marketed foreign vaccines Flublok (recombinant influenza protein antigen) and Fluad (split vaccine + adjuvant). It is an innovative vaccine containing a new adjuvant that has not been marketed either within or outside China. Preclinical data shows that this vaccine exhibits superior humoral and cellular immunity, and if successfully approved, it is expected to outperform traditional influenza vaccines, offering higher protective efficacy.

South China Vaccine's biological vaccine technology platform is based on its proprietary intellectual property rights of the insect cell-baculovirus expression system (BEVS) and mature production and continuous protein purification process technology. It has established a new gene-engineered vaccine research, pilot testing, and industrialization platform to develop recombinant protein nanoparticle vaccines. Compared with vaccine products developed through other technological approaches, recombinant protein nanoparticle vaccines based on the BEVS system feature good post-modification, high immunogenicity, high expression levels, fast construction speed, and high safety. Currently, products under development include seven products such as quadrivalent influenza vaccine and RSV vaccine.

Clinical Trial Application for iView Therapeutics' IVW-1001 Ophthalmic Eyelid Wipe Accepted by CDE — iView Therapeutics Named among Top 50 Emerging Biotech Innovation Companies for Third Consecutive YearIVW-1001 is a highly efficient and selective TRPM8 agonist that increases neural activity after topical application, transmitting a cooling and refreshing sensation to the central nervous system via the ophthalmic branch (V1) of the trigeminal nerve. On one hand, the signal enters the brainstem and is output to the lacrimal gland to promote basal tear secretion (to increase ocular surface moisture), while on the other hand, the cooling sensation itself can reduce eye discomfort and pain, alleviating symptoms of dry eye disease. Unlike traditional eye drops, IVW-1001 is administered by wiping it on the eyelid area, allowing the drug to effectively penetrate through the dermal surface into the eyelid and ultimately reach the channel location in the ocular surface tissue (cornea). Data from the proof-of-concept (POC) clinical trial conducted in South Korea showed that IVW-1001 takes effect within one week of use, rapidly promoting tear secretion from the lacrimal gland, thereby providing direct symptomatic treatment and significantly improving patient symptoms.