[Edaily Reporter YU JIN-HEE ] The proprietary platform technologies of domestic biotech ventures have been selected one after another by Japan’s top-tier global manufacturers, which are known for their conservatism. The industry views this as recognition that these technologies have been officially certified as “global standard production platforms.” Raphas Co., Ltd., the Japanese subsidiary of Raphas Co., Ltd.(214260)—a company specializing in soluble microneedles—is leading the charge.

Raphas Co., Ltd. recently signed an exclusive contract manufacturing (CMO) agreement with Hosokawa Micron, a leading Japanese nanomaterials company with a 110-year history. It subsequently secured a contract development and manufacturing (CDMO) agreement for biosensors with Murata Manufacturing, a major electronics components manufacturer ranked among Japan’s top companies by market capitalization.

This is the result of aggressive research and development (R&D). Over the past five years, Raphas Co., Ltd. has invested more than 20 billion won in R&D—a difficult decision for a biotech startup. As a result, the company surpassed the 30 billion won mark for the first time last year, though it did not yet turn a profit.

However, the industry expects that as Raphas Co., Ltd. gains recognition in the market as the global standard production platform for microneedles, its profitability will improve rapidly alongside revenue growth. In fact, Raphas Co., Ltd.’s net loss has steadily decreased from 6.6 billion won in 2022 to about half that amount last year. The company expects to turn a profit within three years, even as it continues to invest in R&D for new growth drivers such as “DF19001,” an immunotherapy for allergic rhinitis.

In a written interview with Kwon Yu-ri, CEO of Raphas Co., Ltd., we discussed the significance of this series of contracts and her blueprint for expanding market share in the global healthcare market. The following is a Q&A with her.

- What message do these recent consecutive contracts send to the market?

△In a nutshell, it means that Raphas Co., Ltd.’s microneedle technology has been fully recognized as a global standard production platform. The biggest hurdles most biotech startups face when signing formal contracts with global companies are mass production capacity (scale-up) and compliance with strict Good Manufacturing Practice (GMP) standards. Japanese companies with rigorous technology verification processes, such as Hosokawa Micron and Murata Manufacturing, have selected Raphas Co., Ltd. as their final partner. This fact alone attests to Raphas Co., Ltd.’s manufacturing yield and GMP compliance. Raphas Co., Ltd. is now proud to say it has moved beyond being a mere manufacturer of cosmetic patches.

-The practical value of the contract with Hosokawa Micron is

△The most notable term in the contract with Hosokawa Micronis “exclusive CMO.” The two companies already successfully completed prototype verification procedures earlier this year. The pace of commercialization is expected to be extremely rapid. Hosokawa Micron’s microcapsules, which utilize biodegradable polymer (PLGA)-based nano-encapsulation technology, have been combined with Raphas Co., Ltd.’s soluble microneedles. High-performance hair loss and hair regrowth products based on this technology are scheduled to be shipped through the two companies’ global distribution networks. As a result, Raphas Co., Ltd. will generate long-term, stable revenue from exclusive manufacturing. In effect, the company has secured a powerful cash cow that instantly resolves the issue of uncertain revenue—a chronic weakness often cited in biotech startups. Technologically, the integration of nanoscale capsule technology has dramatically improved the rate of drug penetration into the skin and its duration of action. This will serve as the key to expanding the pharmaceutical pipeline beyond the cosmetics sector into areas such as obesity and diabetes, where the precise, quantified delivery of active ingredients is essential.

- What is the technical background of the CDMO agreement with Murata Manufacturing?

△It is a high-value-added project that integrates Raphas Co., Ltd.’s soluble microarray patch (MAP) with Murata Manufacturing’sultra-precise biosensors and bio-batteries. The “smart patch” currently under joint development by the two companies can be painlessly applied to the skin to manage subcutaneous fat. At the same time, it is an innovative product that allows users to monitor in real time, via a smartphone app, the rate at which fat within their bodies is being broken down. This initiative is underpinned by a disruptive innovation strategy aimed at completely transforming existing painful and expensive hospital-based procedures—such as fat-dissolving injections and ultrasound treatments—into an everyday, data-driven home care ecosystem. The collaboration is based on a division of labor in which Murata Manufacturing supplies hardware such as batteries and electrodes, while Raphas Co., Ltd. is responsible for developing and mass-producing the needles—the bio-contact components—and the formulation. The project offers immense potential for future expansion into the telemedicine and wearable diagnostic patch markets.

-The specific operating principle is

△Put simply, it is a “self-powered diet patch” that melts the body’s own fat—specifically, neutral fat—and uses that fat as fuel to power itself. The operation follows a precisely designed four-step process. First, when the patch is applied to the skin, microscopic microneedles pierce the skin’s cellular layers painlessly. At this point, lipase—a fat-breaking enzyme applied to the tips of the needles—is injected into the subcutaneous fat layer. The injected enzyme reacts with the solid triglycerides, catalyzing hydrolysis and beginning to break down the fat. As the fat is broken down during this process, a byproduct called glycerol is formed. This glycerol serves as the key fuel that powers the battery. The micro-needles draw the glycerol generated beneath the skin back up toward the main body of the patch via capillary action. Finally, when the glycerol reaches the bio-battery—an enzyme fuel cell developed by Murata Manufacturing Co., Ltd. located at the top of the patch—it triggers a chemical reaction. This generates an electrical output of approximately 0.5 volts (V) and 0.2 milliamps (mA). This power drives the wireless sensor inside the patch, which transmits real-time body fat breakdown data to a smartphone app. Existing bio-batteries primarily used glucose in the blood as fuel. This product is the industry’s first to directly utilize substances produced by the breakdown of body fat as fuel. It requires no external batteries or separate charging processes whatsoever. This enables the production of ultra-thin, ultra-lightweight wearable patches. Since it generates electricity using only enzymes and oxygen found in the human body, it offers maximum biocompatibility and is safe.

- Raphas Co., Ltd.’s achievements to date are

△Since its establishment in 2014, Raphas Co., Ltd.has led the commercialization of soluble microneedle technology. In 2015, the company established a factory in Shizuoka, Japan, and subsequently partnered with Japanese direct-sales giant “Kitano Tatsujin” to rapidly increase sales of its needle patches. The product was listed in the Guinness World Records in the needle category. In 2020, the company established an additional research institute in Shizuoka to focus on technological advancement. Building on this foundation, it now supplies high-performance products to renowned Japanese skincare brands such as “Dr. Shirabo.” Recently, the company has been expanding its reach into the consumer goods and quasi-drug markets through partnerships with Daisho Pharmaceutical’s “Clinilab” and Kracie. Furthermore, by signing a series of major contracts with Hosokawa Micron and Murata Manufacturing, the company is striving to evolve into a digital healthcare platform.

-Key investment points to watch for in Raphas Co., Ltd. are

△Developing an in-housepipeline of new drugs incurs enormous costs and carries the risk of clinical trial failure. In contrast, the CMO and CDMO business model—which integrates global companies’ core technologies into Raphas Co., Ltd.’s microneedle production platform, as seen in these contracts with major Japanese corporations—fundamentally reduces that risk. It is a highly efficient structure that also shares profits resulting from successful commercialization. Raphas Co., Ltd. is serving as the core pillar, leading the commercialization effort. Establishing a foothold in the Japanese market—renowned for its stringent standards—will serve as a global guarantee for future entry into the North American and European markets. Building on this collaboration, the company aims to maximize shareholder value by expanding its business territory across the board—from digital healthcare and medical aesthetics to telemedicine, digital therapeutics (DTx), and smart wearables.