Amid a sharp decline in stock price due to the shifting of funds towards the AI boom, Oneness Biotech’s founder, William Lu, personally hosted a press conference on the 24th, unveiling six major strengths of the company. He emphasized that this year’s new drug development has surpassed expectations, with six products actively under development. Notably, Fespixon has already been launched in Singapore, Malaysia, and China, marking Oneness Biotech’s official entry into the international market.
William Lu outlined six key R&D achievements for 2024:
Development of chronic wound medical devices and pharmaceuticals, achieving multi-country regulatory approvals for market entry.
Publication of three new scientific papers in international medical journals, bringing the total to 12.
Attainment of certifications and documentation approvals under the three major global medical device quality certification systems, critical milestones for accessing international markets.
Completion of a successful Phase II clinical trial for the world’s only broad-spectrum therapeutic targeting COVID-19 infection.
Advancement of a subcutaneous injection treatment for atopic dermatitis into Phase II clinical trials.
Development of a novel metabolism-based weight-loss drug with an innovative mechanism of action.
Oneness Biotech has also finalized its second out-licensing deal for a new drug, making it the only pharmaceutical company in Taiwan to achieve two licensing agreements with signing fees exceeding USD 30 million. Fespixon, now in its revenue-generating phase, has secured approval for multiple chronic wound indications in the U.S. and is the first drug to be launched in China, Singapore, and Malaysia. Over three years of availability in Taiwan, Fespixon has accumulated sales exceeding NT$100 million, with a compound annual growth rate of 39%, and 99% of sales are from out-of-pocket purchases. Negotiations for distribution and sales licenses are ongoing in North America, the EU, Brazil, and the MENA regions.
Addressing market concerns about Fespixon’s slower-than-expected revenue growth, William Lu explained that as a physician-prescribed drug with a novel mechanism of action, the initial market entry phase requires time for hospital procurement approvals and educating healthcare providers and patients on its usage. Additionally, achieving reimbursement coverage under local healthcare systems demands the accumulation of substantial local usage data. Lu noted that the initial launch coincided with the COVID-19 pandemic, which delayed drug review committee meetings in many hospitals, hindering procurement. While the company could boost its monthly revenue figures through acquisitions, Lu emphasized that Oneness Biotech prioritizes sustainable development over short-term financial gains.
Commenting on the decline in stock price, Lu did not rule out the possibility of short sellers targeting Oneness Biotech to profit from market fluctuations. However, he attributed the issue primarily to investors focusing on short-term metrics rather than the long-term value of new drug development. This has led to speculative trading behavior and market volatility. To address these challenges, Oneness Biotech plans to enhance transparency, adjust its shareholder structure, and accelerate the introduction of specific measures, including attracting strategic international investment partners. These efforts aim to reduce the influence of retail investors and minimize the company’s vulnerability to market rumors and sentiment-driven fluctuations.
Resource: 創辦人路孔明揭六大利多 合一研發超目標 打進國際盃
