• Following positive Phase IIa results for oral Rentosertib in GENESIS-IPF with good tolerability, a favorable PK profile, and dose-dependent efficacy improvements, the inhalation solution has received IND clearance from the CDE.
• The inhalation solution is designed for targeted lung delivery to achieve rapid onset and high local bioavailability at lower doses, while reducing systemic exposure and related side effects.
• Rentosertib inhalation solution is the 13th program from Insilico’s AI-driven pipeline to receive IND clearance, further demonstrating how Pharma.AI could reproducibly drive the discovery and development of novel molecules from preclinical development to clinical validation.

CAMBRIDGE, Mass., April 29, 2026 /PRNewswire/ — Insilico Medicine ( “Insilico”, HKEX:3696 ), a clinical-stage, generative AI–driven drug discovery company, today announced that the inhalation solution of Rentosertib (ISM001-055), the company’s first-in-class drug candidate with AI-identified novel target and AI-developed molecule structure, received IND clearance from CDE. Notably, Rentosertib inhalation solution is the 13th program from Insilico’s AI-driven pipeline to receive IND clearance, further demonstrating how Pharma.AI could reproducibly drive the discovery and development of novel molecules from preclinical development to clinical validation.

The IND clearance supports a Phase I study to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of Rentosertib inhalation solution. The study will consist of two parts: (1) a randomized, double-blind, placebo-controlled Phase I trial in healthy participants involving single ascending dose (SAD) and multiple ascending dose (MAD) cohorts; and (2) a non-randomized, open-label evaluation in patients with Idiopathic Pulmonary Fibrosis (IPF) receiving multiple doses. Approximately 80 subjects are expected to be enrolled.

“We are pleased to receive CDE IND approval for Rentosertib inhalation solution.” says Feng Ren, Ph.D., Co-CEO and CSO of Insilico Medicine. “In prior clinical studies, oral Rentosertib showed good tolerability, a favorable PK profile, and dose-dependent efficacy trend, strengthening our confidence in its mechanism and clinical potential. We look forward to seeing the Rentosertib inhalation solution deliver positive clinical results again in both healthy volunteers and patient populations. The inhalation solution is designed for targeted lung delivery, with the goal of achieving higher pulmonary exposure and faster onset at lower doses while reducing systemic exposure and optimizing the benefit–risk profile. In parallel, we continue to advance the oral Rentosertib program and remain on track to initiate Phase III trials in the second half of this year.”

Administration by inhalation is a complex drug delivery technology that requires combining formulation and devices, presenting higher technical barriers. Inhalation solutions deliver treatment as vapor or aerosol through special devices into the respiratory tract (i.e. the target organ), which is considered one of the most efficient routes of drug delivery as it may provide advantages including rapid action onset, high bioavailability, lowered effective dose and reduced side effects with a noninvasive and targeted route of administration.

In preclinical studies, the inhalation solution of Rentosertib was able to achieve higher lung exposure with low systemic exposure and demonstrated antifibrotic and anti-inflammatory efficacy in animal models. Moreover, it showed good pharmacokinetic (PK) and safety profiles, as well as good stability and solubility.

“The CDE IND clearance for the Rentosertib inhalation solution further validates Insilico Medicine’s sustainable, scalable, and reproducible AI-driven drug discovery and development workflow.” says Alex Zhavoronkov, Ph.D., Founder and CEO of Insilico Medicine. “With our proprietary AI models, we empower the whole process from target discovery to clinical development, expanding into formulation types and geographic areas. To date, we have successfully nominated 30 preclinical candidate compounds (DC/PCC), with the latest emerging from the UAE, a country with no prior history of innovative drug development. At the same time, Insilico Medicine has initiated three Phase II clinical trials and achieved IND clearance for 13 programs across fibrosis, oncology, immunology, and central nervous system disorders.”

Insilico Medicine has established AI-driven drug discovery partnerships with global leading companies, including Eli Lilly, Hygtia Therapeutics, Qilu Pharmaceutical, CMS, TaiGen, ASKA Pharma, Tenacia, Fosun Pharma, and Sanofi, and has achieved important R&D milestones across multiple collaborations. By integrating advanced AI and automation technologies, Insilico Medicine has demonstrated significant efficiency improvements in practical applications, setting a benchmark for AI-driven drug research and development. Compared to the typical 4.5 years required in traditional drug discovery, Insilico’s 20+ nominated candidate drugs from 2021 to 2024 took only 12–18 months on average to progress from project initiation to nomination of preclinical candidates (PCCs), with each project requiring synthesis and testing of only about 60–200 molecules.

Idiopathic Pulmonary Fibrosis (IPF) is a chronic, scarring lung disease characterized by a progressive and irreversible decline in lung function. Affecting approximately 5 million people worldwide, IPF carries a poor prognosis, with a median survival of 3 to 4 years. Current approved treatments, including antifibrotic drugs, can slow disease progression but do not stop or reverse it, leaving a significant unmet need for more effective, disease-modifying therapies.

Rentosertib is a potentially first-in-class small-molecule TNIK inhibitor, discovered and developed with the support of Insilico’s proprietary generative AI platform, Pharma.AI. The FDA granted Orphan Drug Designation(ODD) to Rentosertib for the treatment of IPF in February 2023. The CDE granted Breakthrough Therapy Designation (BTD) to Rentosertib in May 2025.

Rentosertib’s early drug discovery and development process was completed in 18 months with less than 80 small molecules synthesized and tested. This dramatically shortens traditional R&D timeline through AI-enabled target identification and molecule design. The AI-driven workflow was reported in  Nature Biotechnology in March 2024. More importantly, Rentosertib achieved the world’s first proof-of-concept for the efficacy of AI-driven drug discovery with the positive results demonstrated in the GENSIS-IPF Phase IIa trial, and the results were published in Nature Medicine in June 2025.

About Insilico Medicine

Insilico Medicine is a pioneering global biotechnology company dedicated to integrating artificial intelligence and automation technologies to accelerate drug discovery, drive innovation in the life sciences, and extend healthy longevity to people on the planet. The company was listed on the Main Board of the Hong Kong Stock Exchange on December 30, 2025, under the stock code 03696.HK.

By integrating AI and automation technologies and deep in-house drug discovery capabilities, Insilico is delivering innovative drug solutions for unmet needs including fibrosis, oncology, immunology, pain, and obesity and metabolic disorders. Additionally, Insilico extends the reach of Pharma.AI across diverse industries, such as advanced materials, agriculture, nutritional products and veterinary medicine. For more information, please visit www.insilico.com

TAIPEI, April 29, 2026 /PRNewswire/ — Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company” or “Jyong Biotech”), a science-driven biotechnology company dedicated to the development and commercialization of innovative plant-derived therapeutics, today announced that it has advanced the market access strategies for its innovative plant-based drugs Botreso^® and PCP, after an analysis of their clinical efficacy and competitive advantages.

As previously announced, its first core product, Botreso^®, has completed four Phase III clinical trials (API-1) in the United States and Taiwan while its second core product, PCP, has successfully completed its Phase II clinical trial. Overall clinical data indicates that Jyong Biotech’s innovative botanical drugs demonstrate significant differentiated advantages over currently prescribed synthetic chemical drugs.

Safety Profile for Long-Term Use

For middle-aged and elderly men requiring long-term medication, safety is one of the most decisive factor. During the clinical trials – a one-year medication period for Botreso^® (Phase III) and a two-year period for PCP (Phase II) – no drug-related serious adverse events were observed, indicating excellent safety and tolerability.

In contrast, current synthetic chemical drugs for BPH treatment are frequently accompanied by side effects such as orthostatic hypotension, erectile dysfunction, and decreased libido. Regulatory and research institutions have associated some synthetic alternatives with serious risks, prompting the US FDA to issue safety announcements regarding high-grade prostate cancer and depression in 2011, and to add suicidal ideation to adverse reaction lists in 2022, alongside independent research linking them to cardiac failure in 2021.

Addressing the Risk of High-Grade Prostate Cancer

Large-scale international clinical trials have shown that while some synthetic drugs for BPH treatment reduce overall prostate cancer incidence, they may paradoxically increase the proportion of high-grade prostate cancer (Gleason Score ≥ 7) when cancer does occur, raising significant clinical safety concerns.

The PCP Phase II trial was a rare large-scale, long-term study in Taiwan, conducted across 20 major hospitals. It involved 135 urologists (representing more than one-tenth of the profession in Taiwan) and 702 subjects over a two-year period. It represents one of the world’s first clinical trials of a botanical new drug conducted in Taiwan specifically for prostate cancer prevention. Results indicated that PCP shows a trend in reducing both overall prostate cancer incidence and the risk of high-grade prostate cancer, effectively addressing medical community concerns regarding the risks of current therapies.

Comprehensive “Treatment + Prevention + Metabolic Management”

Based on clinical data from the clinical trials conducted by the Company, the Company believes that it is establishing a differentiated product positioning:

• Improves Lower Urinary Tract Symptoms (LUTS): Effectively addresses symptoms associated with enlarged prostates.
• Prostate Cancer Prevention: Demonstrates preventative clinical potential.
• Metabolic and Cardiovascular Protection: Reduces triglycerides (P=0.05), significantly lowers total cholesterol and LDL (bad cholesterol) (P<0.05) , significantly increases HDL (good cholesterol) (P<0.05) , and maintains stable blood sugar.

This integrated approach provides benefits without negatively affecting blood pressure, liver function, or kidney function. The Company believes that such a comprehensive profile – combining treatment, prevention, and metabolic management – is highly uncommon among current prostate medications and holds strong appeal for men over the age of 40.

Technological Barriers and Competitive Advantages

Due to the inherent complexity and diversity of their compositions, quality control for botanical new drugs is significantly more challenging than for small-molecule chemical drugs. Jianyong Biotech believes it has successfully established a comprehensive technological platform that includes:

• The purification and establishment of reference standards.
• The development and validation of analytical methods.
• The execution of validation analyses and verification processes.

The Company believes this integrated capability creates a high barrier to entry, rendering the products highly difficult to replicate. Furthermore, it effectively mitigates the risks associated with counterfeiting and generic drug competition, which ultimately helps to extend the period of market exclusivity.

Upgraded Market Positioning and Strategic Value

As a Botanical New Drug protected by global patents, Jyong Biotech believes its market strategies leverage several key advantages:

• Pricing Power: The unique metabolic protection and safety profile allow for premium pricing over off-patent generics, making it attractive to out-of-pocket and high-end medical markets.
• Licensing Potential: The combination of high tolerability, excellent safety (no severe adverse reactions), and multiple clinical benefits makes it an ideal target for international pharmaceutical partnerships.
• Market Scalability: Extends the product scope from a treatment-oriented approach into the fields of preventative medicine and health management.

Globally, over 500 million men aged 50 and above seek treatment for Benign Prostatic Hyperplasia (BPH). The global BPH drug market, valued at $4.1 billion in 2020, is projected to reach $9.8 billion by 2026. While the current treatment market generates approximately $6.5 to $7 billion annually, this figure reflects price reductions due to patent expirations; if valued at on-patent pricing, this market potential exceeds $20 billion annually*.

“Due to their complex composition, botanical new drugs present significant quality control challenges compared to small-molecule chemical drugs,” stated Fu-Feng Kuo, Chairwoman and CEO of Jyong Biotech. “We have established a robust technology platform encompassing the purification of standard references, the development and validation of analytical methods, and the execution of validation analysis. This high barrier to entry makes imitation difficult, mitigates generic competition, and helps extend the period of market exclusivity.”

“Botreso^® is the first orally administered botanical new drug developed in Taiwan to receive US FDA Phase III clinical trial (API-1) IND approval and complete four Phase III trials,” Kuo said. “Holding multi-national invention patents across Asia, the Americas, and the EU, Jyong Biotech has signed letters of intent and investment plans with several international pharmaceutical companies. The company aims to continue expanding strategic, royalty-bearing partnerships to support its global market expansion.”

As of present day, Botreso^® and PCP remain investigational new drug candidates and have not been approved for commercial use in any jurisdiction. Jyong Biotech will comply with applicable regulatory disclosure obligations and provide timely, accurate, and complete updates on material developments.

*Data source: BMC Urology 2025 (Global Epidemiology); IMARC BPH market report; P&S Intelligence market data; Global Market Statistics; Grand View Research (device market); Market Analytics (drug segmentation).

About Jyong Biotech Ltd.

Headquartered in Taiwan, Jyong Biotech Ltd. is a science-driven biotechnology company committed to developing and commercializing innovative and differentiated new drugs (plant-derived), mainly specializing in the treatment of urinary system diseases, with an initial focus on the markets of the U.S., the EU and Asia. Since its inception in 2002, the Company has built integrated capabilities that encompass all key functionalities of drug development, including early-stage drug discovery and development, pharmacology, toxicology, clinical trials, regulatory affairs, manufacturing, and commercialization. Leveraging strong research and development capabilities and a proprietary platform, the Company has been developing a series of botanical drug candidates, including its primary botanical drug candidate, BOTRESO^®, another clinical-stage botanical drug candidate, and other preclinical-stage botanical drug candidates. The Company endeavors to develop and supply first-class innovative drugs to meet customers’ health needs and seeks to be a valuable business organization that is held in high esteem by the public.

For more information, please visit: https://www.jyongbio.com/, https://jyongir.com/.

Forward-Looking Statement

This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the uncertainties related to market conditions and other factors discussed in the “Risk Factors” section of the registration statement, prospectuses, annual and interim reports, and other filings with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

For more information, please contact:
Jyong Biotech Ltd.
ir@jyongbio.com

Investor Relations
WFS Investor Relations Inc.
Email: services@wfsir.com
Phone: +1 628 283 9214

BEIJING, April 29, 2026 /PRNewswire/ — On a clear day at the sprawling coastal industrial park of Sinopec Qingdao Refining & Chemical Co, a major oil refiner in the country, a modest but groundbreaking facility hums quietly by the shore.

Against the backdrop of a massive industrial complex that stretches for several kilometers stands a shipping-container-sized assembly of pipes and meters arranged in a maze-like structure – the heart of China’s first 100-kilowatt factory-scale seawater-to-hydrogen direct electrolysis project, which is turning seawater and sunshine into green fuel.

“After more than a year of research and development, the project has completed over 1,000 hours of cumulative operation and is ready to scale up from research to mass production of green hydrogen,” Qin Weilong, a process expert at Sinopec Qingdao Refining & Chemical and technical director of the “Oriental Hydrogen Island” project, told the Global Times.

Unlike conventional industrial hydrogen production, which often relies on purified freshwater or fossil fuels, this project uses pre‑treated seawater directly, powered entirely by renewable electricity generated from offshore solar photovoltaic panels at a nearby solar farm.

In 2025, China’s total marine economy output reached nearly 11.02 trillion yuan ($1.62 trillion), with a year-on-year growth of 5.5 percent, and accounting for 7.9 percent of the country’s GDP. Utilizing its inherent resources and technological innovation, Qingdao is a prime example of China’s efforts to promote the high-quality development of the marine economy.

Green energy from the blue ocean

The “Oriental Hydrogen Island” produces 20 cubic meters of green hydrogen per hour. The electricity comes from 13 megawatts of installed offshore solar capacity – enough that one hour of sunlight can generate roughly 2,600 standard cubic meters of green hydrogen. By consuming renewable power on site, the project dramatically cuts electricity costs for hydrogen production.

Pointing to a container-sized device covered with pipes and meters, Qin said, “This is our photovoltaic green power plus seawater hydrogen production unit.”

The term “green hydrogen” refers to hydrogen produced with near-zero carbon emissions, typically via electrolysis of water using renewable energy. This distinguishes it from “gray hydrogen” that comes from fossil fuels and “blue hydrogen” that is extracted from industrial byproducts, making it dependent on petrochemical processes. The Oriental Hydrogen Island project represents a clean break: all its input energy comes from solar.

“These solar panels produce enough green electricity in one hour to make about 2,600 standard cubic meters of green hydrogen,” Qin said, pointing to the offshore array. “Direct seawater electrolysis saves both freshwater and the high cost of desalination. It’s a game-changer.”

This on-site trial has fully demonstrated the technical feasibility of using intermittent renewable power for green hydrogen production, opening a new path for large-scale consumption of renewable electricity in the future, Qin said.

Yet Qin remains measured about the journey ahead. “We have validated the feasibility of directly obtaining hydrogen from seawater,” he said. “The ocean offers an endless source of raw materials and power for green hydrogen. We are full of confidence for the future.”

Less than two kilometers away stands China’s first carbon-neutral hydrogen refueling station, which sources its green hydrogen from the “Oriental Hydrogen Island.”

A special hydrogen tanker from Shandong-based Sino Hydrogen Co, a hydrogen supply solutions provider, slowly entered the station. “Refueling 35 kilograms of hydrogen takes only 15 minutes,” said Gao Gang, a station worker. The tankers deliver green hydrogen to downstream users. “We also refuel some of Qingdao’s hydrogen fuel‑cell buses – that process takes about eight minutes and provides enough energy for a full day of operation.”

Experts note that fast refueling and zero emissions, as only water vapor is released when power is generated, are key advantages of hydrogen energy. When applied to urban transportation, hydrogen fuel cell vehicles can add significant “greenness” to the city’s mobility transition.

The outline of China’s 15th Five-Year Plan (2026-30), recently released, calls for focusing on key areas that will drive future development, building a full-chain cultivation system for future industries, and promoting hydrogen energy and nuclear fusion as new economic growth points.

Shandong Province, a major energy and chemical hub, stands to benefit greatly from this technology. A Sinopec Qingdao manager said that seawater-based hydrogen production can support deep decarbonization efforts at coastal steel and petrochemical sectors, enable zero-carbon scenarios for hydrogen-powered heavy trucks, ocean-going vessels, and island energy supply, and help create zero-carbon industrial clusters.

An innovation park that hears the sea’s call

Qingdao, China’s second-largest foreign trade port, is not only harnessing the sea for clean energy but also leveraging its coastal location to attract global talent, technology, and investment. Just a short drive from the port, in the city’s West Coast New Area, lies an elegant business park set against a backdrop of hills and water. On a black marble pedestal by a waterfront terrace, some 30 national flags flutter in the breeze – a visible sign of the park’s international character. This is the Sino-German Ecopark.

Amid the greenery and birdsong, the rumble of container trucks can be heard if sea winds blow from the direction of the nearby Qingdao Port. “Proximity to the port is a top consideration for our tenants,” Kerstin Kaehler, branch manager of the German Enterprise Centre Qingdao, told the Global Times. Kaehler, who is in her early 50s, has spent 27 years in China fostering business communication and helping German and other foreign companies successfully establish themselves in the country.

The center currently houses 44 tenants, most of them small and medium-sized enterprises (SMEs). Half are Chinese companies; the other half come from Germany, the US, Japan, the UK, Singapore, and other nations. “At the end of 2019, we had 27 tenants. Now we have 44,” Kaehler said.

Despite changing market dynamics, she noted that foreign companies’ interest in the Chinese market has not waned. Notably, demand for co-working spaces or small offices is strong, a trend she expects to continue.

“If a company is a world market leader, it is usually also innovative. If they are, then they are willing and able to learn and draw inspiration from everything happening in China in that field,” Kaehler said. “Especially now, as China is rolling out its new five-year economic plan, I believe that foreign companies – especially German SMEs – have a big role to play in China’s efforts to build a modern industrial system.”

From extracting green hydrogen from the sea to attracting foreign expertise and investing in coastal health and wellness resources, Qingdao is steadily implementing the central government’s strategy to advance Chinese modernization by efficiently utilizing marine resources, promoting the high-quality development of the marine economy, and forging a Chinese path of leveraging marine resources to achieve strength.