On November 27th last year, KINTOR PHARMA-B (09939) opened with a sharp drop in stock price, plummeting over 30% and hitting a new low since the company went public. The lowest point during trading reached HKD 2.01, with a maximum decline of over 40%.
The reason for such a market panic was that KINTOR PHARMA-B disclosed the top-line data of its core product KX-826 for the treatment of androgenic alopecia in Phase III clinical trials before the market opened that day. The results showed that, compared to the placebo, the KX-826 group TAHC showed improvement at various visit points, but the difference did not reach statistical significance. This is the third time that KINTOR PHARMA-B has encountered problems in key product Phase III clinical trials, following the setbacks of Puclopramine.
Since then, the stock price of KINTOR PHARMA-B has been declining, hitting a low of HKD 1.18 during trading on January 31st this year, setting a new low since its listing. It has fallen by 67.2% compared to the intraday high of HKD 3.60 on November 24th last year. However, on February 2nd, the stock price of KINTOR PHARMA-B seemed to have turned the corner.
<h2>After the failure of monotherapy, can combination therapy &#34;extend its life&#34;?</h2>
Zhitong App learned that after the market closed on February 1st, KINTOR PHARMA-B disclosed a piece of news: the Phase Ib/III clinical trial of the company's self-developed KX-826 in combination with minoxidil for the treatment of male androgenic alopecia in Chinese patients has been approved by the NMPA.
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Stimulated by this positive news, KINTOR PHARMA-B saw a significant increase in trading volume and a sharp rise in stock price on the morning of February 2nd, with the closing gain exceeding 50% and ultimately closing with a surge of 51.67%. On that day, the trading volume of KINTOR PHARMA-B reached 167 million shares, with a turnover of HKD 273 million and a turnover rate of 37.23%. This turnover set a new record for KINTOR PHARMA-B in nearly a year.
The significant rebound in the secondary market is enough to show the negative impact brought by the failure of the KX-826 monotherapy Phase III clinical trial and the market's expectations for combination therapy with this drug.
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From the previous Phase III clinical trial, the Phase III clinical trial of KX-826 is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topical application of 0.5% concentration of KX-826 twice daily in Chinese adult male patients with hair loss. The primary endpoint of this study is the mean change in non-vellus hair count (TAHC/cm2) in the target area compared to baseline at the end of 24 weeks, and the safety indicators include the type, incidence, and severity of adverse events.
The analysis results showed that the overall safety of the trial was excellent, and KX-826 demonstrated excellent safety performance, with no reports of any serious adverse reactions during the trial. After 24 weeks of treatment, the TAHC results of the KX-826 group showed that KX-826 promoted hair growth compared to baseline, with statistical significance (P&lt;0.0001). However, compared to the placebo, although the KX-826 group showed improvement in TAHC at each visit point, the difference did not reach statistical significance.
In short, KX-826 showed good safety in this clinical trial, but its effectiveness was not significant and did not surpass the placebo. The reason for the sharp drop in the stock price of KINTOR PHARMA-B at that time was that the results were significantly different from the previous Phase II clinical data of KX-826.
On May 11th last year, KINTOR PHARMA-B announced the successful completion of the Phase II clinical trial of Fureitain (KX-826) for the treatment of hair loss in the United States. The results of this Phase II clinical trial showed that compared to baseline, KX-826 promoted hair growth, and the results measured by TAHC in the target area had statistical and clinical significance. Moreover, the 0.5% dose group of KX-826 reached the main endpoint of TAHC at 24 weeks, with a significant increase of 15.34 hairs/cm2 compared to the placebo group (P=0.024), and most subjects saw efficacy at 12 weeks.
At the same time, KINTOR PHARMA-B also announced that the 0.5% concentration of KX-826 BID is the optimal dosage for the Phase II clinical trial, consistent with the Phase II clinical trial of male hair loss in China, and this dosage has been determined as the recommended dosage for the Phase III clinical trial of male hair loss in the United States/global.
From the above data, it is not difficult to see that the surge in the stock price of KINTOR PHARMA-B this time is largely due to the outstanding performance of the Phase II clinical results of KX-826. Another reason is that the combination therapy in the field of male pattern baldness may be better than monotherapy.
Taking the two approved drugs for the treatment of male androgenetic alopecia in China, minoxidil and finasteride, as examples, according to an efficacy observation report on the treatment of male pattern baldness with oral finasteride combined with minoxidil lotion, the efficacy rate of minoxidil alone is about 70%, while the efficacy rate of combined treatment with 1mg finasteride is between 80% and 90%; in terms of significant efficacy, after 6 months of treatment, the monotherapy group was only 20.5%, while the combination therapy group reached 67.9%, showing a significant difference in efficacy between monotherapy and combination therapy.
As the only topically applied treatment for androgenetic alopecia that has been clinically validated and approved, Minoxidil is expected to achieve success again in combination with KX-826.
<h2>How to survive in the highly competitive &#34;Minoxidil market&#34;?</h2>
It is worth noting that the sharp rise in the stock price of KINTOR PHARMA-B is solely due to the approval of the combination therapy Phase Ib/III clinical trial. Next, KINTOR PHARMA-B will face several key milestones, including data disclosure and the final product launch. Especially in the current expansion of the domestic anti-hair loss market, the army led by Minoxidil is rapidly expanding its sales, and market competition is becoming increasingly fierce.
From a market perspective, according to a research report by GrandViewResearch, the global hair loss treatment market is projected to reach USD 8.2 billion in 2022, with a compound annual growth rate (CAGR) of 9.0% from 2023 to 2030. It is estimated that the market size will reach USD 16.02 billion in 2030.
In China, according to the latest data from the National Health Commission, the number of people suffering from hair loss has exceeded 250 million, which means that one out of every six people is experiencing hair loss. Among them, there are approximately 163 million males and 90 million females, with male pattern baldness accounting for 90% of the patients. The hair loss population is getting younger, with 84% of them being under the age of 30, and the largest proportion being young people aged 26 to 30, accounting for 41.9%.
According to the &#34;In-depth Analysis Report on the Anti-Hair Loss Industry in 2023&#34;, the hair health industry in China is expected to grow at a rate of 260% per year in the next 10 years. The market size of hair loss drug treatments in China is expected to reach CNY 15.5 billion by 2031, with an expected compound annual growth rate of 32% from 2021 to 2031.
Against the backdrop of an expanding market, Minoxidil, as an OTC topical treatment for hair loss that has been certified by the National Medical Products Administration, is also expanding aggressively in the domestic market.
Currently, the terminal market size of Minoxidil in China is about CNY 1.5 billion, with Mandy and Dafeixin together accounting for over 90% of the market share of Minoxidil products in China. Taking Mandy as an example, with a market share of over 70% in 2022, the product has experienced explosive growth since 2019. By vigorously expanding pharmacies and online channels, Mandy's sales revenue increased from CNY 250 million in 2019 to CNY 891 million in 2022, maintaining a high-speed growth momentum.
In addition to the above two products, there are currently 10 different specifications of Minoxidil products available in the domestic market, mainly in the form of solutions, lotions, sprays, and gels.
According to Zhitong App, there are currently more than 20 drugs for alopecia areata in Phase II clinical trials worldwide, with a diverse range of drug types. The layout includes domestic companies such as Hengrui Medicine, Kelun Pharmaceutical, and Zelgen Pharmaceuticals, as well as multinational pharmaceutical companies such as Pfizer and Eli Lilly. Last year, Eli Lilly's JAK inhibitor baricitinib (Olumiant) for the treatment of severe alopecia areata in adults and Pfizer's tofacitinib sulfate capsules (Xeljanz) for the treatment of severe alopecia areata in adolescents aged 12 and above and adults were approved in China, further intensifying the competition in the domestic male pattern baldness drug market.
This is obviously not a favorable market situation for KINTOR PHARMA-B, especially as the company is about to reach the &#34;cash red line&#34;. KINTOR PHARMA-B has been losing money for three years since its listing, with accumulated losses exceeding 2 billion yuan. As of the end of June last year, the company had only 691 million yuan in cash and cash equivalents, and the cash flow situation is not optimistic. Even if KX-826 is successfully approved for listing in the future, KINTOR PHARMA-B will still need sufficient funds to develop the market and compete with the likes of minodors. In this expected scenario, the stock price frenzy of KINTOR PHARMA-B may be short-lived.

UTHR

09939

KINTOR PHARMA-B announced that its independently developed combination therapy of KX-826 and minoxidil for male androgenetic alopecia has been approved by the NMPA, sparking market expectations for the drug's combination treatment and causing a surge in stock prices. The company's previous monotherapy clinical trials encountered problems, leading to a sharp decline in stock prices. However, the approval of the combination therapy has brought about a turning point. On February 2nd, KINTOR PHARMA-B's stock price soared by 51.67%, setting a new record in trading volume. KINTOR PHARMA-B hopes to expand its market through the use of combination therapy.

Zhitong

United Therap

KINTOR PHARMA-B

After the failure of betting on the single drug for male baldness, can relying on combination therapy save the life of Drug-B in the pharmaceutical industry?