LG Chem said March 23 that Innovent Biologics, which holds the China license for its gout drug candidate Tigulixostat, has begun dosing the first patient in a Phase 3 clinical trial in China.
Innovent, known for developing new cancer and immunology drugs, has recently added related programs including a gout-flare treatment as it moves into the gout market.
The Phase 3 study will enroll 600 gout patients and compare Tigulixostat with febuxostat, an existing uric acid-lowering drug. The trial will assess the rate of achieving target serum uric acid levels at week 24 and long-term safety over one year of use.
In a Phase 2 trial Innovent conducted independently in China, all dose groups showed a stronger uric acid-lowering effect than febuxostat and favorable safety, LG Chem said.
CHA Biotech and Novartis Korea said March 23 they signed a strategic memorandum of understanding to build an open-innovation cooperation framework based on CGB, the Cell Gene Bioplatform.
The companies said they will set up a system to identify promising biotech startups, support commercialization and help them expand globally.
CHA Biotech said it is accelerating efforts to build a global biotech ecosystem around CGB, which is being constructed in Pangyo Second Techno Valley. The cluster is designed to link research and development, clinical work, manufacturing and business development, centered on cell and gene therapies.
The 'K-Bio CIC Open Innovation Center' will adopt a model from the Cambridge Innovation Center. The partners said the hub will provide shared lab infrastructure, global network connections, clinical access, links to GMP manufacturing and global business development support.
Osstem Pharma said March 23 it is entering the pharmacy distribution market with Okchi, a functional oral care brand.
The first product is a whitening toothpaste designed for ongoing whitening through brushing. The company cited rising demand for professional-grade whitening products and said it will focus on pharmacy-only distribution.
The toothpaste contains 3.0% hydrogen peroxide, the maximum allowed under standard manufacturing criteria for over-the-counter tooth whitening products, the company said. It said dental school clinical testing confirmed efficacy: in a test using the same main ingredient, the tooth brightness improvement rate was 85.13% after four weeks, and the improvement effect was confirmed in 100% of cases after 12 weeks.
Osstem Pharma said it will expand the lineup in April with two additional products focused on protecting sensitive teeth and preventing cavities, mainly through pharmacy channels.
Bukwang Pharmaceutical said March 23 it held a co-promotion agreement ceremony with Servier Korea on March 17 for seven Arthyl and Vastinan products.
The products include five hypertension treatments — Arthyl tablets 4 mg and 8 mg, Arthyl Arginine tablets 5 mg and 10 mg, and Arthyl Plus Arginine tablets — and two angina treatments, Vastinan tablets and Vastinan MR sustained-release tablets.
The companies said they will begin full-scale joint marketing April 1, dividing sales and marketing roles by hospital size. Servier Korea will cover accounts with 300 beds or more, the companies will jointly cover 100 to 299 beds, and Bukwang will handle institutions with fewer than 100 beds.
SK Bioscience said March 23 it signed a contract development and manufacturing agreement with IDT for finished-dose development and production tied to a second-generation Zaire Ebola vaccine project being pursued with Merck & Co. and the International Vaccine Institute.
The company said the deal followed a January announcement by CEPI, the Coalition for Epidemic Preparedness Innovations, of about $30 million in development funding for the project.
The second-generation vaccine effort aims to address the complexity of the current manufacturing process and the burden of ultra-cold distribution. SK Bioscience said the focus is to improve manufacturing yield and thermal stability to strengthen supply stability and access.
Under the agreement, SK Bioscience will produce the drug substance, while IDT will handle finished-dose development and manufacturing using its CDMO expertise and facilities.
* This article has been translated by AI.
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