Huadong Medicine's "Tongyan Needle" will start registration and clinical trial, and is expected to become the fourth approved product in China

Interface News Reporter | Huang Hua

Interface News Editor | Xie Xin

On May 11, the official account of Huadong Medicine issued a document stating that the company's poly-L-lactic acid collagen stimulator Lanluma has passed the international cooperative clinical trial record, and the first subject injection will be carried out in the near future, opening the national multi-center registration clinical research stage. This means that the registration plan for this product in China is being further updated.

At the same time, the official account of Huadong Medicine also introduced that the registration clinical study conducted by Lanluma in China will evaluate its effectiveness and safety for improving mandibular margin contour defects. This should also be the first indication for this product. In December 2022, Lanluma has been approved for the landing in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan.

Lanluma is a medical aesthetic injection product under Sinclair, a wholly-owned subsidiary of East China Medicine. Generally understood, this kind of product belongs to the regenerative medical aesthetic filler, which is currently the "Youthful Injection" with high market attention, compared with physical fillers, they have the ability to stimulate collagen regeneration, so they are also known as "liquid Thermage".

In terms of ingredients, the main ingredient of Lanluma is poly-L-lactic acid (PLLA). The ingredient is also a biocompatible, biodegradable substance. With the need for gradual stimulation of regeneration, it provides a long-lasting filling effect of 18-24 months, which is the biggest difference in terms of treatment results compared to instant fillers such as hyaluronic acid.

In the field of poly-L-lactic acid (PLLA), there are currently three certified products in China. Among them, the first product comes from St. Boma, a domestic manufacturer of medical-grade polylactic acid raw materials. In April 2021, the company led by Academician Chen Xuesi had the first Class III medical device certified "Tongyan Needle" in China, that is, Avalan.

At the sharing meeting on related topics in April this year, the company introduced that the cumulative sales of this product have reached 213,300 units. According to the unit price of 18,000 yuan to 20,000 yuan, the commercial income generated by this product in three years is more than 4 billion yuan. At the same time, judging from the treatment process of three injections of Avalan for two years, the cumulative number of users in China is about 70,000.

In anticipation of the good business prospects of "Tongyan Needle", Aimeike's Wet White Angel obtained the Class III medical device certificate in June 2021. In late January this year, AestheFill, the medical agent of Jiangsu Wuzhongsun Company, was also certified, becoming the first approved imported "Tongyan Needle" in China.

Among the three products, Avalan is a purer poly-L-lactic acid microsphere injection, Wet White Angel is a combination of hyaluronic acid and poly-L-lactic acid microspheres, and Wet White Angel uses poly-bispin lactic acid (PDLLA microspheres), which is a class of materials that can produce a larger volume effect and retain the volume effect after injection, that is, the immediate shaping effect of the product will have certain advantages.

Although the ingredients are slightly different, the "Tongyan Needle" products are all "10,000 yuan needles", with high prices and considerable gross profits. At the same time, because it is in the stage of large-scale, it can also quickly drive the growth of enterprise performance. For example, Aimeike's financial report shows that in 2023, the operating income of gel injection products, including Wet White Angel, will reach 1.158 billion yuan, an increase of 81.43% over the same period. In the same year, the company's revenue and net profit attributable to the parent company reached 2.869 billion yuan and 1.858 billion yuan respectively, a year-on-year increase of 47.99% and 47.08%.

If Huadong Medicine's poly-L-lactic acid collagen stimulator Lanluma is approved in China in the future, the indication may become its advantage. At present, the approved indications of Avalan, White Angel, and AestheFill are all nasolabial fold wrinkles. Globally, Lanluma is the only regenerative product approved for buttock and thigh filling. Therefore, when the product was approved for use in the Hainan Pilot Zone, the first regenerative filler for body shaping appeared in China.

In recent years, Huadong Medicine has continued to deploy in the medical aesthetic industry. In 2023, the company's medical aesthetic business revenue will reach 2.447 billion yuan, accounting for 6.02% of the company's total revenue, of which domestic and international medical aesthetic revenue will account for 50%.

However, in 2023, the growth rate of Huadong Medicine's medical aesthetic business will slow down. During the period, the revenue of the company's overall medical aesthetic segment was 2.447 billion yuan, a year-on-year increase of 27.79%. However, in 2022, the company's medical aesthetic segment will achieve a total revenue of 1.915 billion yuan, a year-on-year increase of 91.11% on a comparable basis (excluding Ningbo, East China).

Huadong Medicine's cross-border medical aesthetics can be traced back to 2018. At that time, the company spent 1.52 billion yuan to acquire the British company Sinclai and obtained products including "Maiden Needle" Eyanshi. At the same time, Sinclai also sells Sculptra microspheres in the European market. Sculptra is the world's first generation of poly-L-lactic acid microspheres, which have been on the market for 25 years and are currently owned by Galderma. This product has not been approved in China.

The results of early clinical trials reflect that high concentrations of L-polylactic acid have a greater stimulation of the body and a high incidence of granulomas. However, complications such as bruising, bruising, edema, allergies, nodules, and infections are considered to be related to the incorrect injection area and injection technique in subsequent use of this type of product. In addition, factors such as improper care and the patient's personal constitution can also lead to postoperative complications.

In the content of the official account on May 11, Huadong Medicine also introduced the progress of domestic registration and promotion of more products, including the completion of the enrollment of all subjects in the Chinese clinical trial of MaiLi Precise, and the completion of the enrollment of the first subjects in the Chinese clinical trial for the new indication of Ellansé type S, whose expected new indication is the frontal part. From the perspective of business strategy, Huadong Pharmaceutical is continuing to promote the domestic registration of previously introduced products to demand the possibility of subsequent commercialization.

Among the products that have progressed, MaiLi Precise is a cross-linked sodium hyaluronate gel containing lidocaine for injection, and its same series of MaiLi Extreme has submitted a domestic registration application and been accepted in April this year. At present, there are no approved products for the MaiLi series in China.

In addition, Ellansé S-type is a polycaprolactone microsphere facial filler for injection, which is the "popular girl needle" of Huadong Medicine. It is the first imported PCL (polycaprolactone) facial filler in China to be certified by the State Food and Drug Administration as a Class III medical device. The product was approved in April 2021, and the first approved indication is the treatment of nasolabial folds and wrinkles.

As of the close of trading on May 10, Huadong Medicine closed at 33.41 yuan per share, down 1.04%, with the latest market value of 58.612 billion.