Beiersdorf Targets KT-939: Kaida Pharma Stock Under Pressure as New Drug Faces Clinical Test

How does AI patent disputes affect KaiTuo Pharmaceutical’s stock price trend?

21st Century Business Herald Reporter Han Liming

Recently, KaiTuo Pharmaceutical has engaged in multiple rounds of public statements with Beiersdorf regarding KT-939 and Tiamindo®630, with business disputes shifting from underlying tensions to open confrontation.

Reviewing the timeline, since March 12, KaiTuo Pharmaceutical has repeatedly announced three cooperation agreements related to the cosmetic raw material KT-939, accelerating its commercialization layout.

On the evening of March 18, Beiersdorf suddenly announced that, to protect its Tiamindo®630 innovation and ensure fair competition, it had been monitoring KaiTuo Pharmaceutical’s external publicity and market activities concerning KT-939 for some time, and had organized teams to conduct scientific evaluation, evidence review, and legal analysis. The work is now nearing completion.

On March 19, KaiTuo Pharmaceutical quickly responded, stating that Beiersdorf’s statement, made without substantial evidence, mentioning KaiTuo Pharmaceutical and KT-939, has damaged the company’s and its products’ reputation and caused stock price fluctuations. The company announced it will further gather evidence and exercise legal rights to protect the legitimate interests of the company and all shareholders.

From March 21 to 22, both sides intensified their statements, escalating the conflict. Beiersdorf reiterated that only rigorous science can stand the test of time; KaiTuo Pharmaceutical directly pointed out that Beiersdorf’s statements have deviated from scientific discussion and are essentially commercial competition behaviors.

Alongside this “public opinion war,” KaiTuo Pharmaceutical’s core product development also progressed. On March 18, KaiTuo announced that its independently developed and potentially first-in-class KX-826 tincture 1.0% for hair loss had obtained top-line data in Phase III clinical trials. However, the secondary market reacted tepidly; since March 18, KaiTuo’s stock price has continued to decline, closing at HKD 2.76 per share at midday on March 23, down 8%, with a total market value shrinking to HKD 1.376 billion.

Acceleration of KT-939 Commercialization Sparks Dispute

It is known that KT-939 is a cosmetic raw material independently developed by KaiTuo with whitening and anti-spot functions, officially launching global sales in May 2025. Recently, KaiTuo has announced three cooperation agreements.

First, KaiTuo has signed a strategic cooperation agreement with Funuo Pharmaceuticals, whereby its wholly owned subsidiary Suzhou KaiTuo will supply KT-939 raw material to Funuo Pharmaceuticals and authorize it to develop, produce, and sell whitening and anti-spot products based on KT-939 as the core active ingredient within mainland China, supporting its key product FuliMe® cream for melasma.

Second, Suzhou KaiTuo has separately signed distributor agreements with Guangzhou Wanlu Chemical and Shanghai Fandang Chemical (collectively “Wanlu-Fandang”), authorizing Wanlu Chemical as distributor for KT-939 in South and Southwest China, and Fandang Chemical in East and North China, with Wanlu-Fandang responsible for regional sales.

Third, Suzhou KaiTuo has entered a strategic cooperation framework agreement with Shangmei Holdings (2145.HK), including exclusive clauses, to jointly promote registration of KT-939 as a new cosmetic ingredient in China and related cosmetic products, as well as collaborative R&D and customization of efficacy raw materials, aiming to position KT-939 as a new generation domestic whitening agent with industry influence.

As multiple collaborations are publicly announced, Beiersdorf’s doubts have also surfaced. Based on public statements, the core dispute centers on the novelty, inventiveness of KT-939’s patent, and its technical relation to Beiersdorf’s Tiamindo®630.

KaiTuo states that experimental data related to KT-939 was published in top international cosmetic journals last year, including comparison results with earlier developed products based on similar mechanisms (“KT-939 as a new cosmetic raw material entering domestic and international markets respects the intellectual property and commercial value of pioneers, but firmly opposes any bullying or copycat commercial behaviors”).

Beiersdorf emphasizes that Tiamindo®630 is one of the few innovations in dermatology based on human homologous mechanisms, following strict scientific pathways and validated by regulatory systems. Products containing Tiamindo®630 (such as Eucerin, Nivea) are available in at least 28 countries worldwide, validated by over 120 clinical studies for efficacy and safety, covering all skin tones and types.

Additionally, Beiersdorf mentions that under the Patent Cooperation Treaty (PCT) managed by the World Intellectual Property Organization (WIPO), China’s National Intellectual Property Administration issued a written opinion and search report on KaiTuo’s patent application for KT-939. Public information shows that after comparing cited prior art, the report concluded that the main claims lack novelty and inventiveness.

The report states that “there is no evidence that” the claimed compounds have “better effects” than D2, and structural modifications are routine substitutions in the field, considered obvious and lacking inventive step under PCT Article 33(3). Beiersdorf emphasizes that the cited prior art includes its own granted patent publication (D2: CN103889965A) and published papers.

KaiTuo counters that Beiersdorf’s interpretation of the PCT search report is one-sided, noting that the report is only a preliminary reference; substantive examination by patent offices in various countries has not yet begun, and a negative opinion at the international stage is not a final patent rejection. It is normal for patent applications to receive negative opinions initially, then be granted after responses, amendments, or additional data.

The debate intensifies. An industry insider told 21st Century Business Herald that “KT-939 and Tiamindo®630 molecules are structurally similar, mainly differing at the terminal regions. In biomedicine, relying on original molecules and generating new compounds through modifications in non-core regions aligns with the concept of Me-too drugs. This strategy is legal and often used by latecomers to bypass original patents and reduce early target validation costs. Such new drugs are usually very similar in structure, mechanism, and even pharmacokinetics to the original drugs.”

“Regarding KT-939, a professional patent attorney should assess infringement. Long-term, the key to breaking the deadlock is heavy investment in fundamental science, building R&D systems with genuine innovative target discovery and strict IP compliance,” the insider added.

KX-826 May Be the Key to Breakthrough

Public data shows that KaiTuo was founded in 2009, listed on the Hong Kong Stock Exchange in 2020 at HKD 20.15 per share, peaked at HKD 89 in September 2021, then entered a volatile decline. Currently, the stock hovers around HKD 3, down 96.63% from its peak, with market value significantly reduced.

In terms of performance, KaiTuo is still operating at a loss. According to financial reports, in the first half of 2025, revenue was about RMB 6 million, compared to zero in the same period of 2024. The increase was mainly due to global sales of its high-end cosmetic brand KOSHINÉ. Meanwhile, net loss widened to RMB 83.27 million, up 16.5% year-over-year.

Notably, KOSHINÉ, launched in late 2024, is a new high-end cosmetic brand. By mid-2025, it had eight products, including anti-hair loss, acne treatment, and whitening series. Among these, the anti-acne product with KX-826 as the main ingredient and the whitening series with KT-939 as the main ingredient, both launched in early 2025, are core products.

Industry experts believe that the fastest progressing innovative product is KX-826, which is close to market approval. If approved, it could become a key to commercial realization, alleviating current financial pressures.

According to trial data, KaiTuo claims that the Phase III clinical trial of KX-826 tincture 1.0% for hair loss shows statistically significant and clinically meaningful results, with excellent efficacy and safety. Based on earlier data, the company plans to submit an application for marketing approval to Chinese regulators soon.

Industry insiders further note that KX-826 is the most critical product in KaiTuo’s pipeline and attracts market attention. Once approved, it could fill a gap in the hair loss treatment market, breaking the long-standing reliance on minoxidil and finasteride, and potentially revaluing the hair health market. Given the unmet clinical needs and market void, industry expectations are high for a blockbuster drug in hair loss.

Frost & Sullivan reports that in 2018, the market size for androgenetic alopecia drugs in China was RMB 1.47 billion, growing at a 9.6% CAGR to RMB 2.32 billion in 2023; it is expected to continue growing at 15.3% CAGR from 2023 to 2028, reaching RMB 4.733 billion.

However, as the market for hair loss treatments rapidly expands, competition intensifies. Zhendong Pharmaceutical (300158.SZ) stated in its 2025 semi-annual report that its Dafeixin brand pioneered the gender-specific treatment concept, with 23 years of brand history and a 43% market share in the first half of 2025.

On March 16, Codi-B (2487.HK) announced that its new drug CU-40104 (topical dutasteride) received implied approval for clinical trials from China’s NMPA for androgenetic alopecia. Earlier, in June 2025, its CU-40102 was approved for marketing, becoming the world’s first and only topical finasteride approved for androgenetic alopecia, and China’s first topical finasteride approval.

Similarly, on March 16, Fosun Pharma (600196.SH/02196.HK) announced that its subsidiary Jinjihui received approval from NMPA to conduct clinical trials of LBP-ShC4, a proprietary biological therapy for androgenetic alopecia (AGA). The trial was approved by the US FDA in May 2025.

Currently, KaiTuo is at a critical stage of advancing core products amid intensifying market competition. The ongoing developments in the KT-939 dispute and the approval process for KX-826 will significantly influence its future trajectory, attracting ongoing market attention.