On April 17, 2023, Shoukang Group (00575.HK) was pleased to announce that its commercial strategic partner Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd. (“Jiangsu Wanbang Pharmaceutical”) conducted Senstend in ChinaA phase III double-blind placebo-controlled study to treat premature ejaculation has been completed.
The study achieved excellent results, reaching all four common main endpoints: the incubation time for vaginal ejaculation (“incubation time for vaginal ejaculation”), the premature ejaculation index (“premature ejaculation index”), ejaculation control, exponential satisfaction of premature ejaculation, and premature ejaculation index problems. Compared with baseline and placebo, Senstend performed significantly better clinically and statistically in terms of intravaginal ejaculation latency, ejaculation control and satisfaction, and reduced pain. Like the Group's previous studies in Europe and the US, Senstend was well tolerated by Chinese patients and partners, and no new side effects were reported.
The study included 295 male patients aged 20 or above diagnosed with premature ejaculation. Of these, 197 patients were assigned to the Senstend group and 98 to the placebo group; patients were treated for three months at 11 locations in China.
Group CEO Jamie Gibson said, “We are delighted that the results of the phase III clinical study in China are both very important and excellent. This reinforces the results of previous phase III clinical studies in Europe and the US. This is an important milestone in China's regulatory submission process. We are currently expecting the Group's commercial partners in China to submit new drug applications to the National Drug Administration at the end of the third quarter of 2023, and are expected to be approved 12 months later.”
Jamie Gibson further stated, “Senstend is expected to help about 9 million patients in China in its first year of launch, and is expected to grow to over 170 million patients in the tenth year. Our strong partner, Jiangsu Wanbang Pharmaceutical, benefits from the marketing expertise to build e-commerce platforms and an unrivalled nationwide hospital, clinic and pharmacy distribution network as part of the Fosun network to help ensure Senstend's commercial success in China.”
Payment arrangements according to commercial milestones from Jiangsu Wanbang Pharmaceutical
All costs of clinical trials (including all other related regulatory and Senstend application costs) are borne by Jiangsu Wanbang Pharmaceutical. If the China Drug Administration grants Senstend an import license, Jiangsu Wanbang Pharmaceutical will have to pay 5 million US dollars (or about 39 million Hong Kong dollars) to the group (before deducting Chinese withholding tax). Furthermore, after Senstend makes its first commercial sale in China, Jiangsu Wanbang Pharmaceutical will have to pay the group 2 million US dollars (or about 15.6 million Hong Kong dollars) (before deducting Chinese withholding tax).
Furthermore, as disclosed on December 3, 2018, other significant payments that Jiangsu Wanbang Pharmaceutical should pay to the Group in respect of the following items include: If the Group achieves certain annual net sales milestones, Jiangsu Wanbang Pharmaceutical may make a payment of up to 25 million US dollars (or about HK$195 million) and the Group will receive 25% of the net receipt, and the royalty fee calculated as a hierarchical percentage based on net sales based on net sales is as low as ten percent to a high figure, except for certain situations where counterfeit products have successfully entered and affected the Chinese regional market .
The latest market conditions in Europe
The company has recorded good results in several EU countries. Among them, FortaCintm has returned to the market, and the first units in Germany have received strong demand from patients. The manufacturer launched 30,000 units in February 2023, and the next 30,000 units are scheduled to be delivered in July 2023.
Senstend (Fortacin's brand name in China) is a proprietary formulation of two marketed drugs, lidocaine and amipocaine. Through the distribution of metered-dose aerosols developed to treat premature ejaculation, premature ejaculation is a disease that affects 20% to 30% of men in China. According to World Bank estimates for 2022, China's male premature ejaculation population base is very large. There are about 55 million male patients aged 20-59, and will increase to over 170 million. In December 2018, Plethora signed an exclusive license agreement with Jiangsu Wanbang Biochemical Group Co., Ltd., a wholly-owned holding company of Shanghai Fosun Pharmaceutical, to sell Senstend in ChinaTreating premature ejaculation.
Shoukang Group is a diversified investment group headquartered in Hong Kong and currently holds various enterprises and strategic investments in the healthcare, health and life sciences sectors. The group has a strong investment record, and since its initial public offering in May 1997, the group has generated returns of approximately $298 million to shareholders.