SIHUAN PHARM (00460) welcomes a key catalyst for value reassessment. Recently, the company's subsidiary Meiyankongjiang's self-developed "Sodium Hyaluronate Complex Solution for Injection - Dongyan" obtained the Class III medical device registration certificate from the National Medical Products Administration (NMPA), marking the official market entry of China's first L-carnosine complex solution hydrogel injection.

Analysis indicates that this approval not only demonstrates SIHUAN PHARM's R&D capabilities in the medical aesthetics field, but also sends a clear signal to the market: the company's "medical aesthetics + biopharmaceuticals" dual-engine strategy has entered a substantial harvest period. From an investment perspective, this milestone event will systematically strengthen the company's investment value across four dimensions: product value, profitability, strategic realization, and valuation logic.

**Product Value: Positioning in High-Growth Golden Track, Building Differentiated Competitive Barriers**

In investment markets, the most attractive targets often emerge from industries with "high growth, strong demand, weak supply." "Dongyan" is precisely such a strategic product that accurately positions itself in niche markets.

From a track logic perspective, penetration rate and compliance standardization dual-engine drive allows "Dongyan" to enjoy both industry growth and market share replacement dividends. On one hand, the hydrogel injection market that "Dongyan" belongs to is recognized as a "golden track" in the medical aesthetics sector. Its core driving force stems from Chinese consumers' growing high-frequency rigid demand for "skin quality management." According to market research, China's hydrogel injection product market size (at ex-factory prices) is expected to grow from approximately 4.5 billion yuan in 2025 to 8 billion yuan in 2027, with a compound annual growth rate (CAGR) of 21.5%. This growth rate far exceeds the global market's 10.8% CAGR, highlighting the enormous potential and explosive power of the Chinese market.

On the other hand, as the NMPA continues to tighten medical aesthetics regulations, it brings historic opportunities for compliant innovative products like "Dongyan." Therefore, "Dongyan's" growth logic is dual: Beta returns (industry growth) can enjoy over 20% annual natural growth of the entire hydrogel injection market; Alpha returns (market share replacement) rapidly replace and capture existing non-compliant stock markets under regulatory drive.

This simultaneous capture of "incremental" and "existing" markets provides an extremely certain path for "Dongyan's" rapid volume expansion, making its post-launch growth curve steeper.

**Core Competitive Advantages**

"Dongyan's" core competitiveness lies in building an irreplicable moat through the combination of "technological originality" and "high regulatory barriers." The core component L-carnosine has solid scientific mechanisms in anti-inflammation, antioxidation, and anti-glycation. However, from "skincare ingredient" to "injectable Class III medical device," there exists a huge technical gap. SIHUAN PHARM achieved the first compliant application of L-carnosine in facial injection through years of preclinical research and clinical validation.

Additionally, in China, Class III medical devices are the highest regulated medical products, with lengthy and strict registration approval processes averaging 3-5 years. "Dongyan's" successful approval not only represents official certification of its safety and efficacy but also serves as an extremely scarce "market access permit." This means SIHUAN PHARM has pioneered breakthrough technical and registration barriers, establishing at least 1-2 years of regulatory moat and brand first-mover advantages.

**Financial Value: Strengthening Profit Engines, Significantly Improving Growth Visibility**

In capital market valuation systems, the quality, visibility, and sustainability of profitability often carry more decisive significance than short-term profit scale. "Dongyan's" launch not only represents a new revenue source but also serves as an important strategic pivot for optimizing the company's profit model and healthifying financial structure, significantly improving future performance growth visibility.

Short-term, "Dongyan" creates considerable increments, directly thickening profits. As a self-developed Class III medical device, its profit structure has significant advantages. This combination of "high revenue growth + high profit elasticity" means "Dongyan's" net profit contribution to the company may show exponential growth rather than simple linear increases.

Medium to long-term, "Dongyan" can optimize revenue structure, improving profitability quality and stability. Its addition marks the medical aesthetics segment's formation of a more robust "three-horse carriage" driving pattern - foundational cash cow (Leptobao), value growth pole (Maiden Needle/Youth Needle), and high-frequency traffic pool (Dongyan), enhancing revenue robustness.

**Strategic Value: "Dual-Engine" Matrix Formation, Pipeline Reserves Building Platform Company Long-term Barriers**

"Dongyan's" launch marks SIHUAN PHARM's "self-research + BD" dual-track strategy entering an efficient realization period. Through building a "dual-engine" product matrix and establishing deep R&D pipelines, it systematically establishes long-term competitive barriers in the medical aesthetics track, completing a key leap toward a platform medical aesthetics enterprise.

The "regenerative products + skin quality management" dual-engine driving mode achieves ecological construction of the medical aesthetics segment. On one hand, regenerative and filling camp's Maiden Needle/Youth Needle targets mid-to-high-end markets, positioning for deep anti-aging and contour reshaping. On the other hand, skin quality improvement camp's "Dongyan" meets high-frequency skin quality basic maintenance and comprehensive improvement needs.

This "dual-engine" driving ecological mode gives SIHUAN PHARM's medical aesthetics business a self-reinforcing flywheel effect: Dongyan traffic attraction → customer precipitation → regenerative product conversion → brand value enhancement → feedback to Dongyan trust → attracting more customers.

**Pipeline Reserves and Future Outlook**

Currently, the company's medical aesthetics Class III R&D pipeline reserves are extremely abundant. Five regenerative microsphere products have entered registration stage, and eight hyaluronic acid hydrogel/filling products have entered registration stage. Such rich pipeline reserves mean the company has the potential to launch new Class III device products to market almost annually in the next 1-3 years.

**Conclusion: From Cyclical Dark Horse to Long-term Giant, Valuation Logic Reconstruction**

"Dongyan's" success signals SIHUAN PHARM's medical aesthetics strategy entering a new stage. It represents not only a key piece of the "dual-engine" matrix formation but also reflects the company's strong R&D conversion capabilities and pipeline reserve depth as the cornerstone of long-term value.

From capital market perspective, SIHUAN PHARM's investment logic is reconstructing: from "turning losses to profits" to "high-quality growth," from "single blockbuster" to "platform company," and strategic realization with verified management execution capabilities. As subsequent pipeline continues to realize and commercialization deepens, SIHUAN PHARM is expected to initiate a new round of value reassessment cycles.