Shaperon is accelerating the global commercialization of its key pipeline, NuGel, an atopic dermatitis treatment. After strengthening its intellectual property portfolio by securing a U.S. formulation patent, the company is also refining its follow-up development strategy as it moves ahead with preparations for commercialization.

According to industry sources on Aug. 6, Shaperon received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) the previous day for a patent covering the formulation of NuGel. Once the formal registration process is completed, the company will secure formulation patent rights in the U.S. through 2042.

The patent protects NuGel's formulation technology and, together with previously secured patents covering compounds and manufacturing processes related to the GPCR19 platform, will further strengthen the company's global intellectual property portfolio. The patent is expected to serve as an important asset in securing competitiveness in the U.S. market and in technology licensing negotiations with global pharmaceutical companies.

As investment in the biotech sector remains subdued and the technology licensing market continues to slow, commercialization capabilities have emerged as a key factor determining companies' competitiveness alongside research and development (R&D). Industry observers say strategies that connect drug candidates to clinical development, patents and licensing have become increasingly important rather than simply securing promising drug candidates.

Shaperon has also placed global commercialization of NuGel at the center of its business strategy this year. NuGel is an atopic dermatitis treatment with a novel mechanism that targets GPCR19, an upstream regulator of inflammatory responses, and follow-up development is underway with the U.S. market as its primary target.

The company is preparing a final clinical study report (CSR) based on results from its U.S. clinical trial and plans to refine its follow-up development strategy through consultations with regulatory authorities. Once the CSR is completed in September, Shaperon plans to begin more active discussions on follow-up clinical trials and global licensing based on NuGel's differentiated mechanism of action, safety profile and appropriate patient population.

The company has also been able to focus more closely on NuGel's follow-up development and global commercialization strategy after the Korea Exchange deferred its designation of Shaperon as a company subject to an administrative penalty for improper disclosure.

The global pharmaceutical industry is increasingly expanding in-licensing strategies around drug candidates that have reached later stages of clinical development. Companies consider not only clinical data but also patent competitiveness, market potential and development strategies when deciding whether to acquire a drug candidate. Shaperon plans to pursue NuGel's global commercialization in line with this trend.

Alongside drug development, Shaperon is also diversifying its business portfolio. The company recently secured management control of NeedsTech, a medical and beauty device company, strengthening its healthcare business foundation spanning therapeutics and medical devices.

Through NeedsTech, Shaperon aims to establish a virtuous cycle in which a stable source of cash generation is reinvested into innovative drug R&D and global business expansion.

NeedsTech operates the healthcare brand Hugrab and skincare brand Vude as a medical and beauty device company. The company is reportedly expanding its business at an average annual growth rate of more than 200%, with annual sales reaching approximately $13.3 million.

Shaperon also recently signed a strategic partnership agreement with Leveragen, a U.S.-based nanobody platform company, to begin developing fully human nanobody-based therapeutics. Through this partnership, the company plans to expand follow-up pipelines in immunology and oncology and secure new long-term growth drivers.

Shaperon is accelerating the global commercialization of its key pipeline, NuGel, an atopi …

Shaperon Accelerates Global Commercialization of NuGel…Secures U.S. Patent, Prepares for Licensing Deal