Investing in Eirion, Haohai Biological Technology expands its “external application +classical injection” botulinum toxin product line

On March 3, 2021, Haohai Biological Technology signed an equity investment agreement and product license agreement with Eirion Therapeutics, Inc. (“Eirion”), whereby the company will subscribe to round A preferred shares newly issued by Eirion with 31 million USD and hold about 13.96% shares in Eirion while meeting the agreed transaction milestones.

 

Meanwhile, Eirion granted Haohai Biological Technology an exclusive license to develop, market and commercialize (including sub-packaging and packaging) Type A botulinum toxin product ET-01 for external application, Type A botulinum toxin product AI-09 for injection and small molecular drug ET-02 for treatment of alopecia and poliosis in mainland China, Hong Kong SAR, Macau SAR and Taiwan (collectively “authorized territory”), with a 8 million USD down payment for the license agreement.

 

Presence of Eirion product line

Eirion is a biopharmaceutical R&D company based in Boston, US, currently mainly engaged in research and development of Type A botulinum toxin products (ET-01/AI-09) and small molecular drug(ET-02), of which ET-01 is an innovative botulinum toxin for external application that sees no comparable products marketed in China so far. Meanwhile, the Eirion botulinum toxin products under research that have been included in Haohai Biological Technology’s medical aesthetics business portfolio this time cover two fields of “medical aesthetics + medical use”, covering many therapeutic fields such as crow’s feet and axilla hyperhidrosis.

 

ET-01

ET-01 is a Type A botulinum toxin product for external application, produced by wrapping Type A botulinum toxin molecules using nano- micro-emulsion technology and functioning by first pre-treating skin through unique painless micro-needles and then channeling the emulsion preparations containing botulinum toxin molecules into epidermal tissue through local massage before botulinum toxin molecules penetrate and slowly release into target muscular tissues level by level. The combination of skin pretreatment using micro-needles and emulsion preparations can resolve the pain issues arising from traditional muscular injection of botulinum toxin and reduce the reliance of medical aesthetics institutions upon injection physicians, while reaching consumer populations who cannot accept invasive treatments.

 

Currently, the phase IIa clinical trial of ET-01 crow’s feet/ axilla hyperhidrosis have been completed, and existing clinical trial results show that ET-01’s potential overall efficacy might be comparable to the injectable control products and might last longer. Currently, Eirion is preparing for crow’s feet IIb clinical trials of ET-01, which is expected to be approved for marketing in the US in 2025. Meanwhile, when ET-01 crow’s feet/axilla hyperhidrosis enters the phase III clinical trial in the US, the company plans to conduct the phase III clinical trial in China at the same time.

 

AI-09

AI-09 series Type A botulinum toxin products for liquid injection are easier to use clinically than the widely-adopted lyophilized powder dosage form of the existing Type A botulinum toxin products already on the market. In addition, ET-01 and AI-09 can remain stable at room temperature, thus allowing significantly reduced transport and storage costs of products. Currently, Eirion is pushing for the marketing authorization application for AI-09, which is expected to be approved for marketing in the US in 2025. Meanwhile, the company plans to apply for registration simultaneously in China.

 

ET-02

ET-02 is a kind of small molecular drug directly targeting hair follicle stem cells, capable to prevent generation of aging defects in hair follicle stem cells or reverse aging defects, thus treating such symptoms as alopecia and poliosis. At the present stage, Eirion is conducting pre-clinical studies of ET-02 indications for alopecia and poliosis, expecting to submit investigational new drug application (IND) to FDA in 2022.
 

 
 

Market size of botulinum toxin

So far, all botulinum toxin products approved and registered in China are intended for medical aesthetics, with no products yet approved for medical use. After this investment, Haohai Biological Technology will advance registration and sales of Eirion “medical aesthetics + medical use” botulinum toxin products in China.

 

In recent years, the global botulinum toxin markets have been growing rapidly, and botulinum toxin for medical aesthetics have gradually reached beyond the anti-wrinkle treatment of glabellum wrinkles in the earliest days to wrinkle treatment of the upper 1/3 of face such as crow’s feet and forehead wrinkles. In the therapeutic field of medical use, botulinum toxin has also expanded from movement disorders to hyperhidrosis, extremities spasticity, pain and autonomic nervous dysfunction, among other fields. It is said that botulinum toxin brand Botox currently has 11 “medical aesthetics +medical use” indications approved by the FDA for registration.

 

During 2015-2019, Botox’s sales for medical aesthetics and medical use showed a trend of rapid growth, of which botulinum toxin product sales for medical aesthetics grew from 861 million USD in 2015 to 1.663 billion USD in 2019, with a CAGR of 17.89% in 2015-2019; botulinum toxin product sales for medical use grew from 1.110 billion USD in 2015 to 2.128 billion USD in 2019, with a CAGR of 17.67% in 2015-2019. In 2019, the total Botox sales for “medical aesthetics + medical use” reached 3.791 billion USD.

 

Botox product sales (100 million USD)

Currently, the medical aesthetics market for botulinum toxin in China is characterized by high growth rate and high barriers. According to Soyoung statistics, the botulinum toxin market in 2019 accounted for 32.67% of the domestic injection medical aesthetics market, with a YoY growth rate of up to 90.56%. But the medical use market for botulinum toxin is still lacking in China.

 

“Hyaluronic acid + botulinum toxin + photoelectric equipment”

Haohai’s blockbuster combo for medical aesthetics

Since its inception, the company has established its skin filler product line with three internally-generated hyaluronic acid products of “Matrifill”, “Janlane” and “Hyalumatrix”; by investing in Recros Inc. and acquiring JUVA, the company has expanded its product line to physical skin rotary cutting device, laser and RF skincare photoelectric equipment and reinforced innovative R&D capabilities and product reserves for hyaluronic acid and chitosan biomedical materials; with this investment in Eirion, the company acquired the right to commercialize botulinum toxin products for innovative external application/traditional injection and drugs for alopecia and poliosis treatment in the Chinese market in the future, thus further expanding and improving its medical aesthetics product line and driving its medical aesthetics business forward.