Regulatory Compliance

SystImmune Wins FDA IND Clearance Using Non-Animal Test Methods

Redmond – September 22, 2026 -- SystImmune Inc. has secured U.S. Food and Drug Administration clearance for its Investigational New Drug application for SI-B037, a bispecific antibody, marking the first time the company has built a regulatory submission entirely on New Approach Methodologies (NAMs) rather than traditional animal toxicology studies.

SystImmune replaces animal testing with human organ-on-chip models

The IND package for SI-B037 relied on human organ-on-chip systems and primary human tissue models instead of conventional animal studies to assess nonclinical safety. Dr. Jahan Khalili, Senior Vice President of Research at SystImmune, said the human-relevant models provided a more direct read on a molecule engineered to engage multiple human pathways simultaneously.

Nice Enters European HVM Market With CE-Certified HySecurity Line

London – September 22, 2026 -- Nice has formalized its entry into the European hostile vehicle mitigation (HVM) market, rolling out CE-certified products from its HySecurity division after previously supplying the region only on a project-by-project basis.

Nice Establishes Structured European Route to Market for HySecurity

HySecurity, acquired by Nice in 2016, brings more than 60 years of expertise in hydraulic gate operators and crash-rated barriers for airports, government facilities and data centres. Nice will now support the division with local commercial and technical teams alongside its existing network of installers and system integrators, moving away from ad hoc project sales.

Dutch Study: E-Scooters, Fatbikes Cut Car Use but Raise Cycling Risk

Breda, Netherlands – September 22, 2026 -- Light electric vehicles (LEVs) such as e-scooters, e-cargo bikes and fatbikes could reduce car dependency in the Netherlands but are simultaneously raising cycling accident risk on the country's shared bike paths, according to research from Breda University of Applied Sciences (BUas).

Dutch cycling network faces new pressure from electric micro-mobility

The Netherlands operates the world's most extensive cycling infrastructure, with 22 million bicycles serving 18 million residents across a 153,000-kilometre network. Bikes account for 28% of all trips nationally, a model increasingly studied and replicated by cities globally. That system is now being tested by a growing volume of LEVs entering the same narrow cycle paths.

Beactica Starts IND-Enabling Studies for Glioblastoma Drug BEA-17

Uppsala, Sweden – September 22, 2026 -- Beactica Therapeutics AB has initiated IND-enabling studies for BEA-17, a first-in-class oral degrader targeting the epigenetic regulators LSD1 and CoREST, moving the glioblastoma therapy toward first-in-human trials.

Beactica targets a cancer with 15-month median survival and no new treatment in over two decades

Glioblastoma remains the most common and aggressive primary brain tumour, with a median overall survival of approximately 15 months. Standard of care has stayed essentially unchanged for more than 20 years, and immunotherapies successful against other cancers have consistently failed against GBM's immunosuppressive tumour microenvironment.

Bestzyme Opens First Automated Sweet Protein Plant in Jinan

Jinan – September 22, 2026 -- Bestzyme, a synthetic biology unit of GenScript Biotech, has completed what it calls the world's first dedicated, automated smart production line for sweet proteins at its Jinan facility, integrating R&D, mass production and application for the ingredient category for the first time globally.

Jinan facility delivers 100 tons of annual capacity equal to 300,000 tons of sucrose sweetness

The 5,000-square-meter plant runs a fully automated fermentation-purification-freeze-drying process for Bestzyme's flagship Mellia® Brazzein sweet protein. Once operational, the line will produce over 100 tons annually, a volume the company says matches the sweetness output of 300,000 tons of sucrose. Bestzyme expects capacity to potentially double within two years.

Merry Life Advances TML-6 Into 210-Patient Global Alzheimer's Phase 2

Taipei – September 22, 2026 -- Merry Life Biomedical has advanced TML-6, a Taiwan-developed oral therapy for early Alzheimer's disease, into a global Phase 2 trial spanning 20 clinical sites across Taiwan, Sweden, and the United States, targeting approximately 210 participants.

Twenty sites across three countries anchor the trial's design

The study includes nine medical centers in Taiwan, seven sites in Sweden, and four centers in the United States, with Taiwan forming the largest single group of participating sites. The randomized, double-blind, placebo-controlled trial will assign patients to TML-6 100 mg, TML-6 200 mg, or placebo, administered once daily for 52 weeks.

Akeso's Ivonescimab Wins ESMO Late-Breaking Slot for Biliary Cancer Data

Hong Kong – September 22, 2026 -- Akeso, Inc. (9926.HK) will present nearly 30 clinical studies of its bispecific antibodies at the European Society for Medical Oncology (ESMO) Congress in Madrid on October 23-27, 2026, including a Late-Breaking Abstract selected for the Presidential Symposium.

Phase III biliary tract cancer trial secures Presidential Symposium slot

Overall survival results from the Phase III HARMONi-GI1 trial, comparing ivonescimab plus chemotherapy against durvalumab plus chemotherapy as a first-line treatment for advanced biliary tract cancer, will be delivered as a late-breaking oral presentation (LBA8) on October 25 at 16:30-18:15 in Madrid. The presentation will be given by Jian Zhou of Shanghai during Presidential Symposium II.

Kakao Pay, Kakao Bank Partner With Fireblocks on Korea Digital Assets

Seoul, South Korea – September 22, 2026 -- Kakao Pay and Kakao Bank have signed a memorandum of understanding with Fireblocks to build secure onchain infrastructure for Korea's emerging digital asset market, with stablecoins as an initial focus area.

Three parties will test stablecoin distribution frameworks through proof-of-concept trials

Under the agreement, Kakao Pay, Kakao Bank and Fireblocks will jointly explore business opportunities based on Korea's market conditions and infrastructure demand. The companies plan to design digital asset distribution frameworks tailored to Korea's regulatory, security, and service requirements, then run proof-of-concept tests to validate their applicability.

Upside Innovations Launches Field-Adjustable Aluminum Guardrail System

West Chester, Ohio – September 22, 2026 -- Upside Innovations, a SixAxis company, has launched FlowRail, a patent-pending prefabricated aluminum guardrail system that adjusts continuously in the field across slopes, curves, corners and grade changes without custom fabrication or on-site welding.

Adjustable base spans 0 to 20 degrees for any ramp or platform

FlowRail's continuously adjustable base moves from 0° to 20°, keeping posts plumb on ramps, walkways or platforms. Pivoting connections follow curves, corners and switchbacks without splice castings or custom fittings, allowing a single product line to cover an entire installation run.

LX Pantos Americas Sponsors VMA26, Eyes $150B US-Korea Shipbuilding Deal

Teaneck, N.J. – September 22, 2026 -- LX Pantos Americas has secured a regional sponsorship of the VMA26 International Trade Symposium, set for October 13-15 at the Hilton Norfolk The Main in Norfolk, Virginia, as the logistics operator deepens its bet on Virginia as a gateway for Korean-linked trade.

LX Pantos Americas ties sponsorship to expanding Virginia footprint

The company has signed Memorandums of Understanding with The Port of Virginia and the Virginia Economic Development Partnership (VEDP), formalizing cooperation on trade growth, supply chain innovation and economic development in the Commonwealth.