Domestic Antimicrobial Peptide JIJ02 Gel Secured in $12.7M Deal to Address Acne in Over 110 Million Chinese

On August 25, Chengdu PDBio Co., Ltd. (hereinafter referred to as "PDBio") announced that it had reached an agreement with JIUDIAN PHARMACEUTICAL for the transfer of a new peptide drug for acne treatment, JIJ02 Gel (formerly PD-DP-008 Gel). The total transaction amount is 90 million yuan.

According to the agreement, JIUDIAN PHARMACEUTICAL will acquire all the developed achievements and corresponding intellectual property rights of JIJ02 gel, and has signed the "Technology Transfer Contract," obtaining exclusive rights for further global development, production, and commercialization.

JIJ02 Gel is aClass 1.1 Innovative Polypeptide Drug, the active ingredient is derived fromNatural peptides in frog skin secretions,Indicated for common acne vulgaris, with observed strong inhibitory effects on resistant Propionibacterium acnes, showing better efficacy than clindamycin.

On December 25, 2024, JIJ02 gel has just received clinical trial approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and has now entered Phase I clinical trials. Compared with existing marketed products, JIJ02 has potential advantages of lower likelihood of developing drug resistance and superior safety. Currently, there are no similar drugs of this type available on the market either domestically or internationally.

Propionibacterium acnes is a Gram-positive, anaerobic, short bacillus that is intracellular and belongs to the normal skin flora. It generally resides in the hair follicles and sebaceous glands of the skin. Against a genetic background, hormone-induced excessive lipid secretion by sebaceous glands, abnormal keratinization of hair follicle sebaceous ducts, proliferation of follicular microorganisms such as Propionibacterium acnes, and inflammatory and immune responses all contribute to the pathogenesis of acne.As the disease progresses, a large accumulation of lipids leads to further proliferation of lipophilic and anaerobic *Propionibacterium acnes*, activating acquired immunity.

For the treatment of moderate to severe acne, selecting antimicrobial agents with both antibacterial and anti-inflammatory effects is a commonly used systemic approach targeting Propionibacterium acnes and inflammatory responses. Commonly used topical antibiotics include erythromycin, lincomycin and its derivative clindamycin, chloramphenicol, and fusidic acid, among others.

However, in practical applications, many traditional topical antibiotics target specific cellular processes, which easily induceDrug Resistance, it is not recommended as the first choice for antibacterial drugs, and it is not recommended to use alone or long-term.For the population with acne that is cyclical, has a high recurrence rate, and significantly impacts quality of life—especially patients who have developed drug resistance—new antibacterial drugs are a critical clinical need.

The JIJ02, which has successfully reached a transaction this time, interacts with the cell membrane of Propionibacterium acnes, thereby damaging the cell membrane and compromising its integrity. This causes the leakage of genetic material, nucleic acids, from within the bacterial package, leading to the inability of the bacteria to survive, inhibiting the growth of Propionibacterium acnes, and thus achieving an antibacterial effect. Meanwhile,JIJ02 also has a strong inhibitory effect on drug-resistant Propionibacterium acnes, showing better results than clindamycin.

JIJ02 belongs to a class of antimicrobial peptides (AMPs), also known as host defense peptides. These naturally occurring polypeptide molecules are found in various organisms, including humans, animals, plants, and microorganisms. The peptides possess antibacterial properties and can inhibit the growth or kill a wide range of microbes, including bacteria, fungi, viruses, and even some parasites, playing a crucial role in the innate immune system's defense against microbial infections.

Unlike many traditional antibiotics that target specific cellular processes, AMPs generally target the physical structure of microbial cell membranes, rapidly disrupting the integrity of microbial cell membranes, leading to cell lysis and death. Consequently, the likelihood of microbial resistance is lower. Due to their broad-spectrum activity, AMPs can target multiple pathogens, effectively combating various types of bacteria, fungi, and viruses, making them particularly valuable in addressing drug-resistant microbes. Additionally, some AMPs can modulate immune responses and possess anti-inflammatory potential.

PDBio believes that toxic animals (such as toads, hornets, centipedes, scorpions, leeches, venomous snakes, etc.) have undergone hundreds of millions of years of natural evolutionary selection, leading to the development within their bodies.Animal venoms contain highly functional peptide toxin resources, characterized by high activity, high structural diversity, high transferability of action, high drug hit rate, high production rate of blockbuster drugs, and a high proportion of untapped potential., which is an extremely valuable source of molecules for new drug development. It is estimated that the number of toxic animal peptide sequences in genomic databases may range from 10,000 to 20,000, but in reality, there could be billions.

However, the traditional research methods for active components in venomous animals are inefficient and time-consuming, leading to slow progress. For instance, exenatide, which was extracted from the venom of the Gila monster, required decades of extensive research to identify the active molecule, eventually evolving into semaglutide and achieving significant commercial success.

Therefore, PDBio, founded in May 2021 and led by Professor Mingqiang Rong, a doctoral supervisor from Hunan Normal University, has built the world's largest natural peptide library of animal toxins with over a million natural sequences using multi-omics integration technology. By leveraging a "high-throughput + cloud computing" screening platform and AI technology, the company established a peptide intelligent computing design platform and a peptide activity verification and modification platform, successfully developing highly active, highly specific, and highly stable peptide drug candidates. Currently, the company has developed more than 10 peptide drug pipelines, covering disease areas such as infections, neuropathic pain, and respiratory conditions.

Previously, Professor Rong Mingqiang delivered a keynote speech at the China Pharmaceutical Industry Chain New Resources Conference, mentioning two R&D pipelines of PDBio:

Development of a Novel IPF Inhibitor for Idiopathic Pulmonary Fibrosis (IPF) with Pirfenidone as the Control Drug. This is a new sequence, highly active, and highly selective polypeptide molecule demonstrating unique efficacy: it showed lower hepatic and renal toxicity in preclinical trials; in mouse models of IPF, this molecule is the only compound that can restore the activity and body weight of mice to normal levels in a short period; innovative development of an inhalation formulation allows direct action on the lungs, showing superior therapeutic potential in terms of dosage, efficacy, and safety.

In addition, PDBio is also developing another entirely new peptide structure. In this year's research progress, this molecule has achieved a certain level of activity. Administered through intranasal delivery, this molecule can inhibit calcium currents in the central nervous system, showing promising therapeutic effects for trigeminal neuralgia while also effectively alleviating inflammatory pain associated with osteoarthritis.

From a broader perspective, the novel antimicrobial peptides acquired by JIUDIAN PHARMACEUTICAL represent a bet on the biopharmaceutical (peptide) pathway to address the antibiotic resistance crisis.

Against a large backdrop, the global pressure to restrict antibiotics and the issue of drug resistance are becoming increasingly severe year by year. The WHO lists antimicrobial resistance (AMR) as one of the biggest threats to global health, food safety, and development. An analysis of data from 204 countries worldwide published in The Lancet indicates that in 2019, infections caused by antimicrobial resistance directly led to approximately 1.27 million deaths globally and indirectly caused around 4.95 million deaths.

From an economic perspective, antibioticsDrug resistance leads to longer hospital stays, increased medical costs, and higher mortality rates. United NationsThe 2023 report shows that, without action, the number of deaths caused by AMR infections will rise sharply, potentially resulting in 10 million deaths, even surpassing cancer-related deaths. It may also lead to an annual GDP shortfall of $3.4 trillion over the next decade and push 24 million people into extreme poverty. The increasing incidence of multidrug-resistant bacterial infections has made novel antibiotics a long-term necessity, creating a significant pharmaceutical market.

On the R&D front, as a global public health issue, antibiotic resistance remains in a period of profound change and continuous expansion.On one hand, even if the issue of antibiotic overuse is improved, bacteria and their resistance continue to evolve. It is essential to continuously innovate and improve current anti-infective drugs to provide patients with the best chance of surviving infections. On the other hand, global investment in antibiotics with novel mechanisms against drug-resistant bacteria is limited, progress is slow, and large pharmaceutical companies have shifted their research focus to other therapeutic areas. The supply and demand contradiction in the treatment of drug-resistant bacterial infections has become more prominent.

Therefore, driven by technologies such as multi-omics and AI + macromolecules, antimicrobial peptides, as an innovative drug, are emerging from the biotechnological pathway in the anti-infective field.

The innovative peptide drug JIJ02 for acne is primarily an application validation of the new antimicrobial peptide drug pathway.Despite the increasing clarity of the mechanisms of action of antimicrobial peptides, their practical application still faces numerous challenges. For instance, multiple factors such as antimicrobial spectrum, antimicrobial potency, and dosage design need to be considered simultaneously to enhance antimicrobial activity and targeted delivery. As bioactive peptides, issues related to their stability (e.g., resistance to high temperatures and pH levels) remain unresolved for industrial production. Additionally, the enzymatic degradation mechanisms of antimicrobial peptides hinder the effectiveness of oral administration.JIJ02 gel has selected a more efficient application pathway—transdermal delivery.

Secondly, the potential market and patient population are vast, especially with an urgent need for new drugs to treat drug-resistant acne.

As a common skin disease prone to recurrent episodes, acne predominantly affects adolescents, but can occur in people of all ages. The global incidence rate of acne is9.4%, ranking as the eighth largest disease globally, with a male incidence rate of 8.96% and a female rate of 9.81%. Studies have shown that the prevalence of acne in the Chinese population ranges from 8.1% to 85.1%.

Since it often occurs on exposed areas such as the face, chest, and back, it directly affects the patient's appearance and daily life.The study found that more than95% of people will experience acne to varying degrees, and 3% to 7% of acne patients will have residual scars, significantly impacting their physical and mental health. Particularly in cases of drug-resistant Propionibacterium acnes infections, there is a high clinical demand for new antimicrobial agents with strong inhibitory effects.

Finally, for JIUDIAN PHARMACEUTICAL, this move not only marks its entry into the anti-infective field but also further consolidates and expands its innovative layout in the advantageous area of "transdermal drug delivery systems."

It is reported that JIUDIAN PHARMACEUTICAL"Hunan Province New Type Gel Plaster Engineering Research Center," focusing on the key development direction of "transdermal drug delivery formulations," has established a technical platform for transdermal drug delivery systems, including gel plasters, hot-melt patches, solvent-based adhesive patches, and semi-solid formulations, forming a multi-technical platform for collaborative innovation."The Strategic Layout of 'Combining Imitation with Innovation'". It currently owns hydrogel matrix cross-linking, hot-melt drug loading, multiphase complex semi- Core technologies such as solid preparations, transdermal drug screening, independent development of pressure-sensitive adhesives, and control of transdermal drug permeation have been applied to the development of multiple generic drugs and improved new drugs.

Currently ownsSeven registration certificates for external preparation drugs, with over 20 external preparation products under research and development, six of which have been submitted for production. At the same time, it is committed to the development of new functional materials in the field of transdermal drug delivery, overcoming key "bottleneck" technologies in the development of transdermal drug delivery formulations, achieving the development and industrialization of new materials; and establishing a research and evaluation system for transdermal drug delivery formulations to facilitate the development and market launch of such products.ItsThe core product, Loxoprofen Sodium Gel Patch, is mainly used for the treatment of skeletal muscle diseases such as osteoarthritis, muscle pain, and traumatic swelling and pain.

The semi-annual report released the other day showed that the total operating revenue of JIUDIAN PHARMACEUTICAL was 1.512 billion yuan, increasing by 146 million yuan over the same reporting period last year.Achieving a continuous 5-year increase, up 10.67% year-on-year compared to the same period last year.Net profit attributable to shareholders was 291 million yuan, an increase of 7.2927 million yuan compared to the same reporting period last year.Achieving a continuous increase over five years, up 2.57% year-on-year compared to the same period last year.

To maintain a continuously rising revenue trend, JIUDIAN PHARMACEUTICAL has set its sights on innovative drugs.

References:

VCBeat "Prof. Rongming Qiang from PDBio: Building a Natural Peptide Molecular Library to Boost Peptide Drug Development from the Source"

Tongxieyi Biotech "Combating Resistance with Mechanisms: A Review of Peptide Antibiotics"

"Chinese Expert Consensus on Clinical Severity Grading and Efficacy Evaluation of Common Acne (2025 Edition)"

"Chinese Acne Treatment Guidelines (2019 Revised Edition)"