Huaren Biotech goes public in Hong Kong: Bringing PDGF-driven treatment innovation, breaking the 20-year deadlock in diabetic foot treatment

In the essential demand track of China's pharmaceutical industry, diabetic foot (hereinafter referred to as "DF") has become one of the most "painful" areas due to its high disability rate, high mortality rate, and heavy social burden. With a base of nearly 200 million diabetic patients, over 10 million high-risk DF individuals face a 25% amputation risk, behind which lies the shattering of countless families and the continuous pressure on medical insurance funds.

Even more lamentable is that over the past 27 years, there has been only one FDA-approved DF-specific drug globally that can effectively reduce amputation risk. However, its exorbitant price of over $1,000 per 15-gram unit has deterred Chinese patients. Meanwhile, the domestic market has long been in a state of "zero approval" for locally produced PDGF (platelet-derived growth factor) drugs, leaving clinicians to rely on non-growth factor ointments with limited efficacy.

Now, this long-standing gap is about to be filled. HuaRen Bio, a biotech company planning to list in Hong Kong, after 13 years of dedicated efforts, has achieved a breakthrough in domestic core PDGF wound-healing technology with its 54-patent matrix, full-chain R&D capabilities, and groundbreaking process technology. It is poised to become a "game-changer" in the 100-billion-yuan wound-healing track, particularly in the essential DF segment, demonstrating disruptive therapeutic value.

100-Billion-Yuan Track: The "Long Slope and Thick Snow" of Unmet Essential Demand

The latest data from Frost & Sullivan outlines the immense potential of this track: China's overall wound-healing market size reached 95.7 billion yuan in 2024 and is expected to grow to 118 billion yuan by 2033. The core drivers of this "100-billion-yuan track" are the dual forces of increasing surgical procedures and rising chronic disease prevalence. DF, as the segment with the most essential demand, is showing a severe trend of both "younger" and "aging" populations—by 2033, China's diabetic population is projected to reach 178 million, with DF patients exceeding 10 million, an 11% annual mortality rate, and a post-amputation 5-year mortality rate soaring to 22%, placing a heavy burden on families and medical insurance funds. More critically, this field has long suffered from a fatal treatment gap, with unmet clinical needs being extremely urgent.

Compared to other innovative drug tracks, the DF treatment field is more "risk-resistant." The core logic lies in the topical properties, home-use scenarios, and high compliance of PDGF gel, which greatly enhance treatment convenience. More importantly, its core advantage of "accelerated healing" creates multiple values at the root: for patients, it significantly shortens wound-healing cycles and reduces long-term suffering; for families, it cuts down on transportation, nursing, and lost-work costs from repeated hospital visits; for the national medical insurance system, it reduces high subsequent hospitalization and surgical expenses by lowering infection and amputation rates, offering significant social value.

R&D Barriers and Scarce Pipelines: The Key to Breaking Through DF Treatment

HuaRen Bio's core competitiveness stems from the dual advantages of full-chain technological breakthroughs and scarce pipeline layout. Globally, PDGF drug development faces extremely high barriers. As the only FDA-approved recombinant growth factor for topical use, its efficacy in DF treatment has been clinically validated for over 20 years. Yet, since Regranex's approval in 1997, the FDA has not approved a second drug of its kind in 27 years. China's market has been in a "zero approval" state for locally produced PDGF drugs for 27 years, with only one non-growth factor ointment approved, primarily for mild-to-moderate superficial wounds and ineffective for moderate-to-severe DF. While three PDGF pipelines were initiated domestically, only HuaRen Bio has maintained rapid progress—another company's pipeline has been stagnant for a decade since entering Phase III in 2014, making the competitive landscape nearly exclusive.

Technologically, the company has achieved comprehensive breakthroughs from molecular optimization to process innovation: in molecular design, it removed five cleavage-prone amino acids, significantly enhancing drug stability and activity in vivo; in process, it adopted the Pichia pastoris expression system, achieving 75 times higher expression levels than Regranex's Saccharomyces cerevisiae, drastically reducing production costs. Compared to other DF drugs costing tens of thousands of yuan, HuaRen Bio has stronger pricing advantages. With 54 authorized and pending patents covering molecular sequences, expression systems, formulation processes, and indications, the company has built a solid technological moat. In pipeline layout, the company holds two core products: Pro-101-1 for deep second-degree burns, which has completed statistical analysis of Phase IIb clinical trials, and Pro-101-1 for superficial second-degree burns, which has completed the last patient's exit, making it the fastest-progressing PDGF burn candidate drug in China. Phase IIa data showed the high-dose group's complete healing time was 25% shorter than the placebo. The more strategically significant Pro-101-2 targets DF, currently in Phase II with 83 enrolled patients, demonstrating excellent safety and tolerability. It can cover moderate-to-severe DF patients, effectively preventing mild cases from worsening, with irreplaceable clinical value and scarcity.

Commercial Prospects: From "Life-Saving Drug" to "Household Essential"

The commercial value of HuaRen Bio's core pipeline lies in its transition from a "clinical life-saving drug" to a "household essential." This attribute extends beyond DF patients to various chronic disease families and even ordinary households, fully unlocking market potential.

For millions of diabetic families, Pro-101-2 is a "must-have." The current trend of "younger" diabetic patients, coupled with their fast-paced work lives and fragmented medical visit times, often leads to delayed intervention for minor wounds like blisters or scrapes, which can develop into hard-to-heal DF ulcers. Elderly patients, hindered by mobility issues, face a heavy burden from repeated hospital visits for dressing changes. After its expected 2030 launch, Pro-101-2's topical gel design allows home application without professional assistance, perfectly fitting patients of all ages. Its "accelerated healing" core advantage enables early intervention for diabetic wounds, preventing minor wounds from worsening and reducing amputation risks at the source. In the future, it could join glucose meters, insulin pens, and blood pressure monitors as one of the "four essentials" for diabetic households, readily available to fortify health defenses.

For other chronic disease families, PDGF gel also offers irreplaceable value. Patients with hypertension, kidney disease, etc., often suffer from poor circulation and reduced wound-healing ability, where minor daily injuries can become chronic wounds, imposing long-term care burdens. HuaRen Bio's PDGF product addresses this pain point by shortening care cycles with its efficient healing properties, reducing family care efforts and costs, becoming a "wound care guardian" for chronic disease households.

Even for healthy families, PDGF gel can be a household "emergency staple." Daily life scenarios like burns, scrapes, or post-surgical wound care are common, with traditional methods having long healing cycles and risks of scarring or infection. PDGF gel not only accelerates healing but also reduces scar formation by prioritizing unhealed wounds, balancing "efficient healing" and "aesthetic repair" to meet both emergency care and cosmetic needs.

HuaRen Bio's core product Pro-101-2 not only covers nearly 10 million high-risk DF individuals but also breaks scene limitations with its "whole-family applicability," coupled with dual breakthroughs in efficacy and cost from technological advantages, giving it a far higher commercial ceiling than peers and a clear growth path.

Hong Kong-Listed Scarcity: Triple Advantages Align with Long-Term Investment Goals

Over the past three years, successful Hong Kong-listed 18C biotech stocks have shared three traits: extremely high clinical value, exceptionally optimal competitive landscape, and extremely strong business models. HuaRen Bio perfectly fits these criteria—the unmet essential demand in DF corresponds to high clinical value, its near-exclusive competitive landscape builds barriers, and its high-repurchase consumer healthcare attributes provide a robust business model.

For capital markets, this upcoming "first PDGF stock in Hong Kong" could become one of the more certain biotech picks from 2026 to 2030. For millions of DF patient families, HuaRen Bio's emergence not only signifies the arrival of a "life-saving drug" but also the potential to rewrite countless family destinies.

When HuaRen Bio's PDGF products truly reach millions of households, they will not only change individual DF patient outcomes but also reshape Chinese families' wound care consumption habits. This soon-to-list scarcity, armed with the triple advantages of "100-billion-yuan track + exclusive barriers + all-scenario essential demand," is ushering in a new era of PDGF localization, marking the official start of HuaRen Bio's Hong Kong journey.

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