Source: Daily Economic News

Tai'enkang, which is accelerating its layout in the life science and health industry, has recently achieved continuous good news. Recently, the company's CKBA ointment Phase II clinical trial completed the enrollment of all subjects. If approved for listing in the future, it is expected to become a heavyweight product of the company and create new growth points for the company. As the company focuses on innovative drugs that can break monopolies, truly address unmet clinical needs, and fill clinical gaps, building a diverse and collaborative business ecosystem will inject momentum into the long-term development of the enterprise.
CKBA is making rapid progress

In just one year, Taienkang has made new progress in the research and development of vitiligo drugs.

Recently, Taien Kang announced that its subsidiary, Jiangsu Bochuangyuan Biomedical Technology Co., Ltd., has completed the enrollment of all subjects for the Class 1 innovative drug CKBA ointment for the treatment of vitiligo according to the Phase II clinical plan. It is worth noting that the company only announced in November last year that the first participant in the Phase II clinical trial of CKBA ointment had been enrolled, and the research progress can be described as rapid.

At present, the Phase II clinical trial of Tai'enkang CKBA ointment has completed the enrollment of all 200 subjects, and the overall safety is good. Under blind data, it has shown a good trend of therapeutic effect, demonstrating the huge potential for the subsequent development of this product.

It is understood that vitiligo, as a depigmented skin disease, is prone to recurrence and has a low cure rate, which can cause significant life difficulties and psychological burden to patients. It is estimated that the global prevalence of vitiligo is about 0.50% to 2.00%, and the prevalence of vitiligo in China is about 0.18% to 0.90%. At present, the existing topical drug therapies for treating vitiligo, such as glucocorticoids (TCS) and calcineurin inhibitors (TCI), are off label drugs with long-term adverse reactions and limited clinical efficacy. The clinical demand is urgent and the market size is large.

From the global research status of vitiligo drugs, on July 18, 2022, the FDA approved the first drug used to treat vitiligo - Luketinib. In the global clinical research pipeline for vitiligo, Pfizer's brepocitinib, Pfizer's rituxinib, and Hengrui's imatinib are all at the forefront of development and are all JAK inhibitors.

However, there are currently no drugs approved by CDE for the treatment of vitiligo on the market in China, and there is a significant gap in the market for innovative drugs targeting vitiligo indications, with a large market space for new drugs. Therefore, if Taien Kang CKBA ointment is successfully launched, it is expected to provide innovative and safe treatment options for vitiligo patients, and is expected to become a new growth point for the company.

Taien Kang also stated that with the full enrollment of subjects, the company will accelerate the progress of the Phase II clinical trial of CKBA ointment for vitiligo indications, and plan to submit a breakthrough therapy certification application based on the progress of Phase II clinical trials for vitiligo indications, in order to further accelerate the marketing process of CKBA as a Class 1 new drug for the treatment of vitiligo indications.

Holding 37 independently developed projects

In fact, in addition to CKBA innovative drugs, Taien Kang has continued to increase research and development investment and enrich its product pipeline this year.

In the first three quarters of 2024, Taien Kang's R&D investment reached 61.5976 million yuan, a year-on-year increase of 25.42%. Its main pharmaceutical independent R&D projects are 37, covering multiple therapeutic fields. Some core R&D drugs have huge market space, and 11 of them have submitted drug registration approval applications, forming a good R&D team.

In the core area of gender health, Tai'enkang's self-developed Sildenafil Citrate Oral Disintegration Tablets have obtained registration approval. Finasteride Tadalafil Capsules, Minoxidil Wipes, and Vardenafil Hydrochloride Tablets have all applied for registration. Lidocaine Propionacaine Aerosol has obtained clinical approval. The company will further enrich its product matrix for gender health medication and expand its market advantage in the field of gender health medication.

For the field of ophthalmic medication, Taien Kang currently reserves hydrochloric acid pilocarpine eye drops for the treatment of adult presbyopia and diquat sodium eye drops for the treatment of dry eye syndrome in the ophthalmic pipeline. Among them, the hydrochloride pilocarpine eye drops obtained the drug clinical trial approval notice in March 2024 and completed the first subject enrollment.

At present, the research focus of the industry is on nano polymer micelles, and Taienkang has also made significant progress. The company has been committed to building a key technology platform for functional excipients and nano drug delivery since 2015, and has mastered the development of nano polymer micelles through this technology platform to develop a series of high-end improved new drugs. The company's innovative functional excipients and key technology platform for nano drug delivery mainly include research projects on injectable docetaxel polymer micelles, injectable paclitaxel polymer micelles, and injectable cisplatin polymer micelles. At present, the relevant project is in the pre clinical application research stage.

In addition, Tycoon has also synthesized polylactic acid and polycaprolactone, of which polylactic acid microspheres gel has completed scale-up production and is undergoing biological evaluation.

Some institutions have pointed out that Taien Kang attaches great importance to the role of technology platforms and has established three major pharmaceutical research and development technology platforms, adopting a pyramid shaped research and development strategy. The tower base is for generic drugs, the tower body is for improved new drugs and biopharmaceuticals, and the tower tip is for innovative drugs. The company has a rich reserve of R&D projects, strong R&D capabilities, and has formed a good team. Some core R&D drugs have a large market space, and after the drugs are introduced to the market, they may be expected to enhance the profitability and profitability of the company's self-produced business.

The competitive landscape of core products is good

The continuous breakthroughs in research and development are also related to the strong competitiveness of the company's three core sales varieties: "Hewei Zhengchang Wan", "Aiting Jiu" Dapoxetine Hydrochloride Tablets, and "Volitine".

After obtaining the complete production technology of "Hewei Zhengchang Pills" owned by Thailand's Li Wanshan last year, Taien Kang actively promoted the registration and approval process of Hewei Zhengchang Pills in China and has achieved phased results. Currently, Hewei Zhengchang Pills has submitted an application for domestic drug registration and marketing authorization to the Drug Evaluation Center of the National Medical Products Administration.

Overall, the preparation work for the nationwide market promotion of Hewei Zhengchang Wan has been advanced, especially for well-known chain pharmacy enterprises in existing and blank markets, which have started communication and cooperation. In the first half of this year, Tai'enkang also conducted promotion tests through online platforms such as social media, in order to explore effective marketing models and accumulate experience through replication and promotion nationwide.

Tai'enkang stated that the company is accelerating the registration of domestic drugs related to Hewei Zhengchang Wan and the production landing of Tai'enkang in Anhui. After obtaining the domestic registration approval for Hewei Zhengchang Wan, it will be promoted nationwide to further expand the market share of this variety. In the next 3 to 5 years, it aims to build it into a well-known product in the gastrointestinal field worth over 1 billion yuan.

And the core product of gender health, Aiting Jiu, is similar to Jinge, both of which are the first domestic generic drugs for gender health medication. Taienkang has good channel sales capabilities, and Aiting Jiu may become a key single product of the company in the future, contributing to good sales revenue growth. In addition, its independently developed "Aitingwei" Tadalafil tablets are expected to form a synergistic effect with "Aitingjiu" Dapoxetine Hydrochloride Tablets in the future, synergistically promoting anti ED and anti PE treatments and enhancing brand influence.

In addition, Waritin is a phospholipid complexed iodine preparation operated by Taien Kang, which is an original drug produced by Japan's First Pharmaceutical Industry Co., Ltd. Volitin maintained a stable sales trend in 2022 and 2023, with annual sales revenue remaining at around 185 million yuan and a stable gross profit margin of around 40%. In the first half of this year, Volitin achieved a sales revenue of 87.2586 million yuan, an increase of 4.26% compared to the same period last year. In the long run, the company's goal is to maintain an annual sales revenue growth rate of around 10%.