Xinwei Pharmaceuticals Files for IPO to Advance Innovative Pipeline in Gastrointestinal Therapeutics

The cumulative impact of various factors, including the accelerating pace of life, changes in dietary patterns and habits, and the continuous growth of the aging population, has led to a year-on-year increase in the number of individuals suffering from gastrointestinal diseases.

Given the vast patient population, unmet market needs, and pathogenesis that remains to be fully elucidated in the field of gastrointestinal diseases, tapping into this multi-billion-dollar pharmaceutical niche may be a promising strategy.As an observer of the healthcare industry, VCBeat New Medicine recently interviewed two entrepreneurs with extensive clinical and research experience in gastroenterology to explore how they are driving new drug development in the gastrointestinal field by addressing the most authentic clinical needs.

The “vehicle” for the two scientists’ new drug development efforts is Xinwei Pharma, a pharmaceutical company established in 2018 that focuses on the research, development, and commercialization of novel therapeutics for gastrointestinal diseases. Xinwei Pharma was initially founded by Dr. Zhuang Xianhan, Chairman of Lead Pharma, with support from Dr. Ye Xiaoping of Tigermed and Mr. Lai Chunbao, a seasoned investor in the biopharmaceutical industry. In 2020, Xinwei Pharma completed its Series B financing round, with investors including Yingke Capital and Tigermed; the company is currently raising its Series C funding. Headquartered in Shanghai Zhangjiang Hi-Tech Park (also known as Zhangjiang Pharma Valley), and backed by the Zhangjiang Comprehensive National Science Center, the company is well-positioned to rapidly leverage advantages in information, talent, policy, and R&D resources within the life sciences sector.

Recalling the original intention behind the founding of Xinwei Pharma, Dr. Zhuang Xianhan, Founder and CEO, said:“During my previous career, two profound setbacks in new drug development once made me consider leaving the field of innovative medicines. However, more than a decade ago, a conversation with a former frontline pharmacist reignited my sense of mission to dedicate myself to new drug R&D.”

First SetbackFrom 1993 to 1999, Dr. Zhuang pursued his studies and research in pharmacology and oncology at Zhejiang University. During this period, he participated in the development of a novel cancer differentiation-inducing drug featuring a new molecular entity and a novel mechanism of action, which would be classified as “First-in-Class” by current standards. The research team invested over five years and substantial funding into the project; however, development was ultimately terminated due to unsatisfactory therapeutic index and other key metrics. As this was a commercially driven R&D collaboration with a corporate partner, the data generated over several years could not be published as academic outputs.

The Second SetbackThis occurred between 2002 and 2005, when Dr. Zhuang was the operational head of Shanghai Leading Pharma Co., Ltd. In Dr. Zhuang’s view, the company’s core project—a selective COX-2 inhibitor (classified as a “Fast Follow” by current standards)—had the potential to uphold the company’s value, given its solid scientific foundation for initiation and promising market prospects. However, the project had to be terminated due to the impact of Merck’s “Vioxx incident” in 2004 (the FDA announced that Vioxx, also a COX-2 inhibitor known as rofecoxib, tripled the risk of myocardial infarction and sudden cardiac death in patients taking high doses). Prior to this, the company had invested over RMB 30 million and more than three years in activities ranging from computer-aided drug design (CADD) to compound screening, identification of candidate molecules, and preclinical trials. This setback constituted a devastating blow to the company.

Dr. Zhuang Xianhan candidly remarked, “These two incidents had a profound impact on me. In addition to undermining my confidence in developing innovative drugs, the latter was nothing short of a fatal blow to my professional career. While handling project-related matters and winding down certain company affairs, I kept my distance from new drug R&D for at least five years. What ultimately renewed my determination to engage in new drug development was a conversation—or rather, a resonance—with a former student who had transitioned from a frontline pharmacist role to hospital management.”

Before pursuing his graduate studies, Dr. Zhuang taught a cohort of pharmacy students at a municipal health school; most of these graduates went on to work as pharmacists in hospitals. During a period when he kept his distance from new drug R&D, Dr. Zhuang returned to the city for a business event and took the opportunity to meet with two of his former students. One of them, who was relatively introverted, explained that he had transferred to an administrative position in a government agency, citing that the longer he worked as a pharmacist, the more pronounced his sense of powerlessness became.

The student said, “Well-established drugs with clearly defined pharmacological mechanisms are frequently out of stock due to razor-thin profit margins. The so-called new drugs emerging in endless succession are mostly repackaged older medications, priced far beyond their actual value. Medications with merely placebo effects occupy a significant portion of drug formularies, with some even being hailed as ‘miracle cures.’ It is deeply distressing to see patients leave the pharmacy window clutching prescriptions costing two to three thousand yuan, carrying large quantities of medications that offer little targeted therapeutic benefit and often serve only as placebos. For certain patient populations, this money represents their hard-earned savings. Why can’t we develop genuine new drugs with proven efficacy, as discussed in class—drugs with clearly elucidated mechanisms of action and quantifiable therapeutic outcomes?”

“Although the students focused more on the social issues of the time, this is not unrelated to the lack of innovation in the pharmaceutical industry. Innovative drugs almost always have to go through numerous trials and tribulations before they can be successfully used in clinical practice. The success rate of new drug development is indeed extremely low, which many traditional pharmaceutical companies try to avoid. However, from another perspective, precisely because of the difficulties involved in developing new drugs, when we succeed in accomplishing this task, its value—including clinical value, social value, and the resulting economic value for the enterprise—is enormous,” said Dr. Zhuang.

As the company’s operational management mechanism continues to improve, Xinwei Pharmaceutical, in addition to making employee career development the core of its human resources strategy, is also continuously attracting top-tier industry talent to join its team. This includes Dr. Zhuang’s long-time friend, who currently serves as the company’sProfessor Chen Bingguan, Senior Vice President and Chief Medical Officer.Professor Chen Bingguan has long been engaged in clinical surgery and immunological research in China, Japan, and the United States. Prior to returning to China, he served as an Associate Research Scientist at Yale University for six years. Upon his return, Professor Chen held several positions, including Director of Surgery at Shanghai Dongfang International Medical Center, Adjunct Professor of General Surgery and Doctoral Supervisor at Tongji University School of Medicine, and Founding Medical Director at Hefei BOE Hospital. In addition, Professor Chen serves as Vice Chairman of the Translational Medicine Committee of the Chinese Society of Clinical Oncology (CSCO), Editorial Board Member of the World Chinese Journal of Digestology, and Executive Deputy Editor-in-Chief of the Chinese Journal of Endoscopy.

Dr. Haiming Huang, Chief Scientific Officer, studied under Professor Sachdev Sidhu, an internationally renowned scientist in the field of antibody engineering; previously served as Associate Director at Innovent Biologics (Suzhou) and as a Scientist at Amgen’s Asia R&D Center;Chief Operating Officer Liu Liyuan, previously held positions at WuXi AppTec and Joincare Pharmaceutical, among others, leading teams to contribute to the successful regulatory submissions of multiple INDs, NDAs, and ANDAs for their respective companies;Chief Financial Officer Du Shenghua, formerly served at PwC and Haitong International, with over 15 years of experience in the financial industry, specializing in A-share and H-share listing planning, corporate governance, and domestic and cross-border M&A financing.

The team is characterized by interdisciplinary collaboration and complementary expertise, spanning technical and management domains such as oncology, bioinformatics, antibody engineering, microbiology, immunology, regulatory affairs, investment and financing, and financial management. Through the joint efforts of the team, Xinwei Pharma has achieved rapid and continuous development.

In the face of its chosen therapeutic areas, NewWei Pharma often faces skepticism: most new drug companies currently opt to focus on major refractory diseases such as cancer.Compared with malignant tumors, most gastrointestinal diseases are not fatal in the short term. Do they truly hold clinical value and market potential? Will Xinwei Pharma, as a startup pharmaceutical company, succeed?

Dr. Zhuang Xianhan replied, “A company’s success stems from its commercial success; for pharmaceutical companies, the key to commercial success lies in the clinical value and market potential of their products.”

Taking the gastrointestinal (GI) field, where Xinwei Pharmaceutical focuses, as an example, GI diseases are common and frequently occurring, with a remarkably high market ceiling.The core pipeline asset of the company, NP101, is indicated for irritable bowel syndrome with diarrhea (IBS-D). Currently, there is no method worldwide that can completely control this disease, and China lacks any therapeutic agents specifically approved for IBS-D. Eluxadoline and rifaximin, two drugs launched in the United States in 2015, are effective only in a subset of IBS-D patients. Upon market approval, NP101 will become the first innovative small-molecule drug indicated for IBS-D in China and the third globally.

Among gastrointestinal disorders, functional gastrointestinal disorders (FGIDs) have an incidence rate of 42–61%, ranking second only to the common cold in frequency among internal medicine outpatient visits. Of these, irritable bowel syndrome (IBS) and functional dyspepsia are particularly typical, characterized by a chronic and refractory course. Although not life-threatening, they cause significant distress and severely impair patients’ quality of life.

Diarrhea-predominant irritable bowel syndrome (IBS-D) accounts for more than 40% of all IBS cases. Its pathogenesis has not yet been fully elucidated, and there is a lack of ideal therapeutic agents. It is estimated that the direct and indirect costs attributable to IBS in the United States amount to as high as $30 billion annually.

Professor Chen Bingguan added, “The gastrointestinal (GI) tract represents a therapeutic area with significant scalability, making it well-suited for our sustained in-depth development. On one hand, we can focus exclusively on this segment to tap into its substantial market potential. On the other hand, we can leverage this as a strategic entry point to expand indications of drugs under development into other fields, such as dermatological diseases, oncology, and autoimmune disorders.“Regarding our choice of therapeutic area, Dr. Zhuang and I have shared a long-standing consensus: never engage in what we do not fully understand. New drug development is inherently fraught with high risks of failure. Leveraging our decades of clinical and research expertise in the gastrointestinal field, we have a deeper understanding of unmet clinical needs and development challenges, thereby enhancing the success rate of drug R&D.”

Based on Xinwei Pharmaceutical's differentiated strategic layout and the core team's profound understanding of gastrointestinal diseases,Xinwei Pharma has currently established a systematic technology platform. This systematic technology platform is built on a set of universal underlying logic:

① The team has repeatedly evaluated the clinical manifestations, pathogenesis, and prevention and treatment strategies of gastrointestinal diseases through an iterative process from clinical practice to basic research and back to clinical application, thereby establishing a systematic and comprehensive scientific framework encompassing target discovery and validation, as well as drug discovery, design, development, clinical trials, and clinical application.

Professor Chen Bingguan explained, using the development of drugs for diarrhea-predominant irritable bowel syndrome (IBS-D) as an example: “Our first new drug indication is IBS-D. IBS-D and other functional gastrointestinal disorders (FGIDs) are a special category of common diseases within the digestive system. In clinical practice, many severe diseases affecting other organ systems, such as those undergoing tumor radiotherapy and chemotherapy, are often accompanied by symptoms of functional gastrointestinal disorders during their onset or treatment course (which we define as ‘functional gastrointestinal disorder-like conditions’). These symptoms directly impact patients’ ability to adhere to effective treatment for their primary disease. Therefore, we design corresponding therapeutic approaches and medications based on these needs.”

“Furthermore, digestive system cancers, particularly gastrointestinal malignancies, already account for a substantial proportion of all human malignancies. Inflammatory bowel disease (IBD), which shares similar symptoms and certain overlapping pathogenic mechanisms with irritable bowel syndrome (IBS), is another major serious condition posing significant threats to health and life, with its incidence continuously rising. Taken together, this represents a market with immense potential! Moreover, the focus of the pathological basis almost entirely lies in”Gastrointestinal MucosaFrom the constantly renewing epithelial cells to the submucosal immune tissues and nerve endings, the structure and function of the gastrointestinal mucosa are closely linked to what is known as the “second brain of the human body” and the “largest immune organ,” offering numerous scientific and clinical questions ripe for breakthroughs.

“Building on our IBS drug development efforts, we have expanded into the R&D of therapeutics for gastrointestinal malignancies and inflammatory bowel disease, with one focus being on gastrointestinal disorders”Professional Strategies, on the other hand, expanding into areas focused on new advancements in cancer and autoimmune diseasesCommercial Risk Hedging Strategies.” added Dr. Zhuang Xianhan.

② After determining the therapeutic targets and development pathways, we will leverage both internal and external technical platforms to collaboratively conduct drug design, screening, and development.

NewFor Medicine possesses relatively stronger capabilities in medicine, bioinformatics, and biotechnology than in chemistry. Therefore, in the realm of small-molecule drug development, after target validation, the company designs, screens, and identifies candidate compounds through outsourced collaborations, and subsequently advances the R&D process either independently or in partnership. In the area of large-molecule drugs, NewFor Medicine’sBioinformatics-Synthesized Phage LibraryPossesses significant advantages in molecular discovery and engineering within the fields of nanobodies, peptide therapeutics, and related areas. To date, has independently initiated or undertaken commissioned projects to successfully develop high-affinity SARS-CoV-2 neutralizing antibodies targeting unique epitopes, HER2 bispecific antibodies, and other candidates. Existing projects have entered into further collaborative development with domestic and international research institutes, universities, and leading industry enterprises, including follow-on collaborative development with a national-level research institute abroad.

Moreover, the RNAi technology platform is becoming a technical highlight for Xinwei Pharma.During his tenure as an Associate Research Scientist at Yale University, Professor Chen Bingguan initiated pioneering work in this field and secured multiple patented technologies. Currently, Dr. Chen Bingguan leads the RNAi molecular design platform at Xinwei Pharma, focusing on autoimmune disorders and malignant tumors of the gastrointestinal tract. By modulating target genes through RNA interference technology, his work aims to achieve therapeutic outcomes for these diseases.

The revenue growth generated through licensing and collaborative R&D of outcomes from our independently developed platforms constitutes a supplementary profit model for the company.

NewMed Pharma has currently established nine drug candidates in its pipeline, with core indications covering four major areas: functional gastrointestinal disorders, inflammatory bowel disease, gastrointestinal tumors, and intestinal infectious diseases; the scope of indications has been expanded to include rheumatoid arthritis, other solid tumors, and multidrug-resistant tuberculosis.

Among them, NP101, the most advanced candidate, has completed the enrollment of all 720 subjects and the specific trial procedures for its supplemental Phase III clinical trial, which was conducted in accordance with the Rome III criteria (the international diagnostic and therapeutic standard system for IBS).In terms of efficacy, the previously completed Phase III clinical trial based on Rome II criteria actually enrolled 430 cases, with an effective rate of 65.16%. In terms of safety, no serious adverse reactions have been reported for NP101 to date.

In terms of market prospects, China currently has a population of over 1.4 billion, with approximately 2.5% suffering from IBS-D. Based on an estimated consultation rate of 20% and medication rate of 30%, the current market size is RMB 4.3 billion. In recent years, due to intensified social competition and changing environmental conditions, the affected population has shown an expanding trend, with rapid growth in both incidence and consultation rates. Over the next five years, the market demand for IBS-D treatments in China is projected to reach RMB 8.5 billion.

Among these, the NP101 project (indication: IBS-D) is expected to submit its New Drug Application (NDA) this year; the NP102 project (indication: complicated skin and soft tissue infections) is anticipated to file its NDA within the next two years; and NP107 (indication: gastric cancer) has obtained clinical trial approval and is currently organizing and conducting clinical trials. The remaining projects are all expected to enter the Investigational New Drug (IND) stage sequentially over this year and next.

Faced with a dense and synchronously advancing pipeline, Xinwei Pharma, as a startup, opts for collaborative R&D with other institutions or pharmaceutical companies, generating revenue through licensing agreements. Meanwhile, by leveraging the resources of its partners, Xinwei Pharma can accelerate pipeline development and mitigate R&D risks.

In terms of future strategic layout, Xinwei Pharma is proactively pursuing market-oriented and internationalized development in both product commercialization and corporate growth. Key elements such as talent acquisition, capital infusion, and alignment with industrial resources are being simultaneously strengthened, as the company transitions from building internal foundations to engaging more deeply within the broader industry ecosystem. Dr. Zhuang Xianhan emphasized, “For companies at either the R&D or commercialization stage, a robust industrial ecosystem is critical to sustainable development. Throughout our growth and transformation, we have actively collaborated with leading industry partners to jointly accelerate the advancement of this ecosystem. Taking pipeline optimization as an example, we enrich our core therapeutic area pipelines through in-licensing projects, while out-licensing non-core assets to leverage external capabilities for faster commercialization, thereby enhancing the company’s overall competitiveness.”

Looking ahead, we expect Xinwei Pharma to further focus on the gastrointestinal field, taking actual clinical needs as the starting point for development, advancing in both breadth and depth, and developing more valuable drugs to benefit patients.