On April 22, Kintor Pharmaceutical (09939. HK) rose sharply, and as of press time, the stock rose more than 19% to HK$1.04 per share, with a total market capitalization of HK$465 million.
The company's significant share price rise is closely related to the positive results achieved by its androbald monotherapy GT20029 in phase II clinical trials in China.
New progress has been made in androbald monotherapy
According to the announcement, the phase II clinical trial in China of a novel protein-degrading chimera (PROTAC) compound targeting the androgen receptor (AR) independently developed by Kintor Pharmaceuticals GT20029 for the topical use of tincture for the treatment of androgenetic alopecia (alopecia or AGA) in men (alopecia or AGA) met the primary endpoint, and the results were statistically significant and clinically significant, and the safety and tolerability were good.
In terms of efficacy, after 12 weeks of treatment, the TAHCs in the GT200290.5% QD group increased by 16.80 cells/cm2 compared with baseline and 6.69 cells/cm2 compared with placebo, both of which were statistically significant (P<0.05), and the TAHCs in the GT20029 1.0% BIW group increased by 11.94 cells/cm2 compared with baseline and 7.36 cells/cm2 compared with placebo, both of which were statistically significant (P<0.05).
In terms of safety, GT20029 tincture had a good safety and tolerability profile, and adverse events occurred during the course of treatment in each group comparable to placebo. In addition, no adverse events related to sexual function were observed in the trial.
In addition, GT20029 1% BIW was the optimal dosing dose for the Phase II clinical trial, which was determined to be the recommended dosing dose for the Phase III clinical trial for male alopecia in China.
Based on the results of the Phase II clinical trial, Kintor said that it will actively deploy GT20029 follow-up clinical strategies, such as conducting a phase III clinical trial in China and a phase II clinical trial in the United States.
Of course, in addition to treating male hair loss, GT20029 also has potential in terms of acne indications. At present, Kintor is preparing to carry out a phase II clinical trial GT20029 for the treatment of acne.
The positive R&D progress of these pipelines not only enhances the competitiveness of Kintor Pharmaceutical in the field of biopharmaceuticals, but also lays a solid foundation for the subsequent commercialization of the company's products.
Unprofitable biopharmaceutical companies with poor product commercialization
According to the data, Kintor Pharmaceutical is a developer focusing on the research of cancer drugs and other androgen receptor (AR)-related diseases, with a rich R&D pipeline, but so far no drug has been successfully launched and contributed to profitability.
From the perspective of R&D pipeline, as of the end of 2023, Kintor has developed 6 clinical stage drug candidates, including KX-826, proxalutamide (GT0918), GT1708F (Hedgehog/SMO inhibitor), GT0486 (mTOR kinase inhibitor) and ALK-1 antibody (GT90001) in addition to the GT20029 mentioned above.
Among them, KX-826 (Fretan) is also indicated for the treatment of androgram baldness and acne, which is one of the core drugs of Kintor Pharmaceutical, and has always been highly expected by the market. But at the end of last year, a single-agent phase III clinical trial of KX-826 for androgenetic alopecia in men did not achieve the expected success.
In the face of this challenge, Kintor Pharmaceutical was not discouraged, but began to change its strategy and launched a charge against the combination of androdgymia and alopecia.
On February 1, Kintor Pharmaceutical disclosed that its self-developed and potentially first-in-class phase Ib/III clinical trial of KX-826 and minoxidil in combination with androgenetic alopecia (AGA) in Chinese adults has recently been approved by the State Food and Drug Administration to evaluate the efficacy and safety of KX-826 in combination with minoxidil in the treatment of adult male AGA patients in China.
It is worth reminding that, generally speaking, the success probability of a new drug from the completion of phase II clinical trial to the completion of phase III clinical trial is less than 1 in ten. For Kintor Pharmaceutical, it remains to be seen whether the combination of KX-826 and minoxidil will be effective.
As a second-generation AR antagonist and ACE2 and TMPRSS2 degrader with the potential to become a best-in-class drug, proxalutamide has completed phase III clinical trials and is the world's leading new crown drug pipeline.
According to the 2023 annual report, Kintor is actively seeking commercialization of proxalutamide and overseas cooperation opportunities, including continuing to seek regulatory approval for COVID-19 indications, and seeking external licensing of mCRPC and COVID-19 indications in various countries. At the same time, the development value of proxalutamide for breast cancer has also been significantly recognized.
In addition, in other disease areas, including mCRPC, liver cancer, idiopathic pulmonary fibrosis, hematologic malignancies and various solid tumors, Kintor has also advanced or completed a number of products in the clinical stage, but there is still a long way to go before the products are commercialized.
Judging from past performance, due to the huge investment in R&D, Kintor Pharmaceutical has already suffered heavy losses.
According to the financial report, from 2020 to 2023, Kintor Pharmaceutical recorded a net loss attributable to the parent company of 508 million yuan (RMB, the same below), 842 million yuan, 954 million yuan, and 1.061 billion yuan, with a total loss of more than 3.3 billion yuan in four years.
During the period, the R&D expenses of Kintor Pharmaceutical were RMB329 million, RMB768 million, RMB828 million and RMB939 million respectively, totaling RMB2.864 billion.
Not only that, the continuous losses have made the funds of Kintor Pharmaceutical more and more tight. As of the end of 2023, Kintor Pharmaceutical's cash and cash equivalents and term deposits amounted to RMB456 million. Judging from the R&D expenditure in the past two years, the funds of Kintor Pharmaceutical are no longer enough to support its expenses for one year.
As of December 31, 2023, Kintor said that there was 111 million yuan of unused bank financing. It is actively pursuing a commercialization path for its core products, and expects cash on hand to support the company's clinical and R&D advancements and the necessary expenses to commercialize its products.
Overall, Kintor has not yet launched a product and it will not be easy to turn around its losses in a short period of time, but the company is striving to change its current financial situation through active strategy and R&D efforts.
In order to achieve a reversal, Kintor needs to accelerate the pace of bringing its R&D drugs to market and realize profitability from these drugs as soon as possible. However, it will take time to find out exactly when the turning point for profitability will be reached.
Author: Hong Xiaodou