Xgene Pharma Advances XG005-03 into Phase II Following Successful Phase I Completion, Building on XG005-02’s Fast-Tracked Phase III in the U.S.

According to the Global Pain Index report released by pharmaceutical giant GSK in 2017,More than 85% of the global population has experienced headaches or bodily pain in their lifetime.According to statistics from the U.S. National Academies, more than 100 million people in the United States suffer from chronic pain; in China, the number of patients with arthritis alone exceeds 100 million.

The analgesic market holds immense potential, ranking second only to oncology drugs and metabolic disease treatments (such as diabetes medications) in terms of total sales revenue. However, due to the complex mechanisms of action and significant R&D challenges associated with analgesics, few new drugs have been approved for market launch.

Recently, known as“The Final NGF Antibody for Osteoarthritis Treatment”—Tanezumab (a novel drug jointly developed by Pfizer and Eli Lilly for the treatment of osteoarthritis, following 15 years and 41 clinical trials) has delivered news:

The FDA issued a document stating that although clinical trials have demonstrated that tanezumab can benefit patients with osteoarthritis, there are serious safety concerns warranting caution. The FDA also expressed skepticism regarding the Risk Evaluation and Mitigation Strategy (REMS) proposed by Pfizer and Eli Lilly for tanezumab, noting that no data exist to prove the effectiveness of this plan. The FDA did not make an immediate final decision on whether to approve tanezumab for market launch.

As multiple NGF antibody drugs have successively received FDA “red light” warnings, a Shanghai-based startup innovative drug R&D company—XG005, a novel analgesic drug developed by Xgene Pharma, has received the FDA’s “green light.”This stands in stark contrast to such events.

Last year, Xgene Pharmaceutical’s XG005-02 (oral formulation) was granted Fast Track designation by the U.S. FDA, enabling it to proceed directly from Phase I clinical trials to pivotal Phase III trials, with the prospect of obtaining new drug approval for the treatment of acute pain.

Recently,Xgene Pharmaceutical Announces Further Good News: Its Core Product, XG005-03 (Transdermal Formulation), Has Successfully Completed Phase I Clinical Trials in Australia and Will Seek to Initiate Phase II Clinical Trials in the United States in the Near Future.

Also in the pain management sector, Tanezumab—a novel drug for osteoarthritis jointly developed by pharmaceutical giants Pfizer and Eli Lilly after 15 years of research, 41 clinical trials, and an investment exceeding $2.3 billion—faces an uncertain market approval outlook. What makes Xgene Pharmaceutical so distinctive that it has earned the rare “green light” from the FDA, known for its extremely rigorous review process?

As a start-up focused on developing innovative small-molecule drugs for neurological and pain disorders, Xgene Pharmaceutical aims to reposition and develop corresponding products based on new clinical findings from already marketed drugs, addressing market demands to meet the widespread unmet clinical needs of pain patients worldwide.

Xgene Pharmaceutical leverages its proprietary “dual-effect” drug conjugation R&D platform,Rationally pair and conjugate drugs with complementary or synergistic mechanisms to develop products that demonstrate clinical efficacy and an improved safety profile.

“Dual-Efficacy” Drug Development PlatformThis is the secret to Xgene Pharmaceutical’s team achieving rapid results in new drug development, and it also constitutes the company’s core competitiveness that distinguishes it from other new drug developers. Characterized by low R&D risk, fast development speed, and high market certainty, these advantages have been partially validated in the current development stage.

According toDr. Xu Jinghong, Co-founder and CEO of Xgene PharmaceuticalIntroduction: The Company’s Debut ProductXG005 is a conjugate of first-line analgesics for pain management, namely nonsteroidal anti-inflammatory drugs (NSAIDs) and neuropathic pain agents.As both drugs are already in clinical use, their advantages and disadvantages are well defined. The novel molecules generated through conjugation exhibit improved chemical, biochemical, and pharmacokinetic properties; therefore, the conjugated products offer superior clinical therapeutic benefits.

Regarding Xgene Pharmaceutical’s inaugural product, XG005, this drug not only treats concurrent inflammatory and neuropathic pain but also significantly reduces the gastrointestinal and central nervous system side effects that are inevitable when either class of medication is administered alone or in combination. Meanwhile,As molecules developed via the conjugation platform are novel compounds with unique pharmaceutical properties, they are eligible for new compound patents, ensuring comprehensive intellectual property protection for the product. Furthermore, indications can be expanded beyond those of the parent drug, and routes of administration can be modified, thereby enhancing the convenience and scope of clinical use.

Currently, the conjugate drug XG005-02 (oral formulation) is set to enter Phase III clinical trials for acute pain in the United States in 2021. Meanwhile, an application for a clinical pharmacokinetic bridging study in China will be submitted in the first half of this year, accelerating its domestic market launch. Dr. Xu stated that while Xgene Pharmaceutical, Inc. continues to develop international markets, it also strives to provide highly effective and superior-safety products to the vast number of domestic patients suffering from arthritis and cancer-related pain as early as possible.

Behind this distinctive new drug development logic is the powerful founding management team of Xgene Pharmaceutical. The team members not only boast credentials from top-tier universities but also possess extensive experience in drug R&D and the industry.

Dr. Xu Jinghong, Co-Founder and CEOHe is an internationally renowned toxicologist who has overseen more than 30 Investigational New Drug (IND) applications for new drugs in Europe, the United States, and Asia, with over 20 of these advancing to Phase II/III clinical trials and one drug already marketed (Taigenxy®). To date, Dr. Xu has published more than 40 academic papers, holds five patents, and served as editor-in-chief for two books: Cancer Risk Assessment (John Wiley & Sons, Inc.) and Guidelines for Clinical Laboratory Testing in Laboratory Animals (Shanghai Scientific Popularization Press).

After earning his Ph.D. in Toxicology from the Massachusetts Institute of Technology (MIT), Dr. Xu completed his postdoctoral research at the University of California, Berkeley. In his first position after graduation, he served as Director of the Division of Toxicology and Pharmacology at the U.S. Environmental Protection Agency (EPA). Subsequently, Dr. Xu held executive roles at several international pharmaceutical companies, including Merck & Co., HEC Pharm, InnoStar Bio-Technology, and TaiGen Biotechnology, accumulating over 20 years of industry experience. Dr. Xu also served as President of the Chinese Society of Toxicology (USA) and is a board-certified toxicologist recognized by the American Board of Toxicology.

Dr. Feng Xu, Co-Founder and Chief Scientific OfficerDr. Xu Feng holds a Ph.D. in Organic Chemistry from Boston University. During his postdoctoral fellowship at Harvard University, he studied under Professor E.J. Corey, a Nobel Laureate in Chemistry. Dr. Xu has held multiple R&D leadership positions at Tularik and XenoPort in the United States. He has participated in the development of more than 10 new drug candidates, including two that reached clinical trials, with one approved for market launch: Horizant®. He brings over 20 years of industry experience.

The two executive scientists work in seamless synergy, leveraging their respective strengths to lead highly efficient company teams with strong execution capabilities.Within just five years, the Xgene Pharmaceutical team advanced the development of a new chemical entity (NCE) drug to Phase III clinical trials in the United States.

Over the past decade, more than 400,000 deaths in the United States have been attributed to opioid overdose, with over 67,000 cases occurring in 2018 alone. According to data from the U.S. Centers for Disease Control and Prevention (CDC), more than 140 Americans die from drug overdoses each day, and 91% of these individuals had a history of opioid misuse prior to their death.

U.S. Drug Overdose Mortality Rates, 1999–2018 (Source: Public Data)

According to statistics, the medical and social “side effects” caused by opioids, the “broad-spectrum drugs” in the field of pain management, result in direct and indirect economic losses amounting to $80 billion annually.

To address the rampant issue of opioid addiction, countries in Europe and America have implemented a series of strict control measures in response to the opioid crisis.However, the vast global patient population suffering from acute and chronic pain has not disappeared. Consequently, unmet clinical needs in the pain management market have shifted toward novel analgesics with comparable efficacy but fewer side effects. This highly distinctive international landscape has presented Xgene Pharmaceutical with an unprecedented opportunity for growth.

Relevant market data indicate that the pain medication market holds immense potential, ranking as the third-largest pharmaceutical market by sales revenue, surpassed only by oncology drugs and medications for metabolic disorders such as diabetes.In 2019, the global market size for pain medications was approximately $60.6 billion, while the market size for opioid analgesics in urgent need of replacement approached $20 billion.Driven by the significant market potential in this field, pharmaceutical giants such as Pfizer, Johnson & Johnson, GSK, and Eli Lilly have actively established their presence in the pain management sector.

Over the past decade, governments at all levels have provided strong support for technological innovation, leading to a surge in innovative biopharmaceutical companies and the emergence of diverse R&D models. Xgene Pharmaceutical believes that although small drug development companies struggle to compete with international pharmaceutical giants in terms of funding and personnel, it is crucial to explore an innovative drug R&D model with distinct characteristics in the areas of “innovation models, development risks, and market competition.”

Due to its highly distinctive logic and philosophy in new drug development, Xgene Pharmaceutical has attracted investment from multiple institutions, including Morningside Venture Capital, Ping An Ventures, Taifu Capital, and Formosa Plastics Investment, as well as from Indonesia’s Sinar Mas Group.Currently, Xgene Pharmaceutical has completed its Series A and B financing rounds, raising a total of nearly $30 million. The company will initiate its Series C financing round in the near future.

According to Dr. Xu Jinghong, with the smooth progress of clinical trials and the acquisition of a series of encouraging experimental data,Xgene Pharmaceutical plans to schedule its IPO for next year.

In the future, the company will leverage the efficient collaboration of its global team and its unique new drug R&D model to develop internationally competitive products that address the global challenge of pain management, bringing relief to a vast number of pain patients both in China and abroad.