In the biomedical field, the mantra of "10 years, 1 billion US dollars, and a 10% success rate" hangs like the Sword of Damocles, reflecting the high investment, long cycle, and high risks associated with innovative drug R&D.

How to break this paradigm? Founded in 2017, Nanjing Qingpu Biotechnology Co., Ltd. ("Qingpu Biotechnology") has taken long-acting new drugs as its strategic fulcrum, precisely entering the field of pain management—a clinical area with huge yet largely unmet needs.

After eight years of dedicated effort, fruitful results are emerging. This biomedical enterprise focusing on non-addictive analgesic new drugs has not only achieved successful commercialization of its first product but also cultivated a rich and technologically leading product pipeline in the pain management field. Several of its under-development new drugs are pioneering innovations in China and even globally, demonstrating vigorous development vitality and broad market prospects.

Looking back to the end of June this year, Qingpu Biotechnology announced the first shipment of Meloxicam Injection (Ⅱ) (Chinese trademark: Putanning®), ushering in a new phase of long-acting postoperative analgesia. Putanning® is China's first non-steroidal anti-inflammatory drug (NSAID) injection for once-daily administration, providing sustained 24-hour long-acting analgesia. It is also the first new analgesic drug from China to obtain marketing approval from the U.S. Food and Drug Administration (FDA).

Codenamed QP001, this product addresses the clinical challenge of "frequent dosing" in postoperative pain management. Xu Bin, BD Director of Qingpu Biotechnology, explained: "Currently, commonly used injectable drugs for postoperative pain management require multiple daily administrations or continuous infusion through indwelling catheters, causing great inconvenience to both doctors and patients. In contrast, a single injection of Putanning® delivers continuous potent analgesia for 24 hours, maintaining significant efficacy especially during the final phase (18-24 hours) of the drug's duration. This avoids nocturnal breakthrough pain caused by the failure of short-acting analgesics during postoperative hospitalization, effectively reducing pain-related complications, facilitating patients' postoperative recovery, and alleviating anxiety. In terms of safety, compared to other NSAID injections, Putanning® offers superior safety for special groups commonly encountered in surgery. For example, in patients with mild hepatic or renal impairment and elderly patients, no dosage adjustment is required for Putanning®, whereas other NSAID injections need to be used with caution or at reduced doses."

Beyond Putanning®, Qingpu Biotechnology has another blockbuster product in the pipeline for postoperative pain management—QP002. This drug represents a new generation of global long-acting local anesthetic compound analgesics. Administered once before surgical skin closure, it provides long-lasting pain relief for 3 to 5 days, making it ideal for small to medium surgical incisions. It is reported that the product has completed multiple Phase II clinical trials with excellent clinical outcomes and is about to enter the Phase III clinical stage.

In addition, QP-6211, another independently developed long-acting analgesic new drug from Qingpu Biotechnology, has achieved significant progress. As of October 22, 2025, subject enrollment for the second Phase III clinical trial has been fully completed. Compared to globally marketed long-acting drugs targeting the same receptor, QP-6211 offers longer duration of action, lower injection-related risks, and stronger selectivity for pain-sensing nerves. The product is about to enter the New Drug Application (NDA) phase and is expected to become the world's first 3-7 day long-acting formulation of its kind.

In the field of chronic pain management, Qingpu Biotechnology has also built a globally competitive product pipeline. Among them, QP5113 is indicated for neuropathic pain and is China's first ultra-long-acting analgesic new drug with efficacy lasting up to 3 months. DLV208 targets osteoarthritis pain and is poised to become the world's first ultra-long-acting analgesic new drug in its target class, offering 3-6 months of sustained efficacy.

Guided by global unmet clinical pain management needs, the company has established a matrix of long-acting, potent analgesic products capable of sustained release in vivo for days, weeks, and even months, supported by multiple proprietary technological platforms for long-acting drug delivery and small molecule drug screening.

"Among current biomedical companies, our pipeline in the pain management field not only advances more rapidly and comprehensively but also features each new drug with distinct clinical advantages over both marketed and investigational products worldwide. We are truly creating value for both doctors and patients while filling critical clinical gaps," said Xu Bin.

How has Qingpu Biotechnology crossed the "Valley of Death" in biomedical innovation to achieve such outstanding development?

"The development of pharmaceuticals follows the evolution of the human disease spectrum. The popularization of antibiotics in the 1950s and 1960s helped humanity overcome the high mortality rate of infectious diseases. With increased life expectancy, drugs targeting cardiovascular and cerebrovascular diseases became a major R&D focus and were launched in the 1970s and 1980s. Today, we see vigorous growth in oncology and autoimmune therapeutics. Each era has spawned numerous blockbuster drugs," noted Xu Bin. "As life expectancy and per capita GDP continue to rise, the human disease spectrum is constantly evolving, driving changes in clinical needs and waves of innovation in the pharmaceutical industry. Medical needs may shift from 'extending survival time' to 'improving quality of life,' making pain management the next critical strategic track."

The founding team astutely recognized this evolutionary trend in the disease spectrum and strategically positioned the company in the pain management field ahead of competitors, achieving strategic differentiation.

Notably, the global success rate for developing new molecular entities in pain management is as low as approximately 2%, resulting in only a handful of similar new drugs approved in China over the past two decades. The reasons for failure are complex, involving scientific challenges such as target feasibility and molecular defects, as well as the difficulties in translating non-clinical pain research to clinical applications.

"The fundamental difference between humans and animals lies in our highly evolved nervous systems. For example, significant species-specific differences exist in the subtypes, structures, and distributions of ion channels on nerve cells. This often results in analgesic drugs that show efficacy in animal models failing to demonstrate therapeutic effects in humans," explained Xu Bin. Furthermore, as a highly subjective experience, pain presents unique challenges in clinical research, including significant placebo effects and substantial individual variability, further increasing R&D uncertainty and failure risks.

To address these challenges, Qingpu Biotechnology chose to enter the field through the long-acting new drug pathway. "First, there is an urgent clinical need for long-acting non-opioid analgesics. Over half of the new postoperative pain drugs approved by the FDA in the past decade are long-acting non-opioid analgesics. Second, the drug molecules in our initial pipeline already have established safety and efficacy profiles. Once technical breakthroughs are achieved, the probability of success is relatively higher," said Xu Bin.

Taking the R&D journey of QP001 as an example: while oral formulations of its active ingredient, meloxicam, have been on the market for some time, their indications are limited to inflammation management and cannot meet the demand for potent analgesia. Due to poor solubility, oral meloxicam exhibits slow absorption and low systemic exposure, resulting in delayed onset and insufficient efficacy. Through extensive literature research and data analysis, Qingpu Biotechnology identified significant potential for improvement in this molecule—if systemic exposure could be substantially enhanced, meloxicam could become one of the most potent non-steroidal anti-inflammatory analgesics available.

However, the path to improvement was far from smooth. Over the past two decades, several international pharmaceutical companies have attempted to overcome the formulation technical bottlenecks of meloxicam, ultimately failing to achieve success.

"Our approach was to develop it as a high-concentration intravenous injection, but overcoming the key technical bottlenecks through formulation technology became our greatest challenge. It took the company a full two years to identify the technical route," recalled the founding team, comparing the process to a Science Driven "floor-laying" effort: "In the early stages, we systematically tested and eliminated theoretically promising solutions one by one. After accumulating substantial data on the patterns of failed approaches, through continuous combinatorial exploration, we finally found the only correct 'brick.'"

In fact, as the world's first new-generation "solution-type" high-concentration long-acting intravenous meloxicam injection, QP001 not only delivers 24-hour continuous potent analgesia but also achieves exceptional formulation characteristics, including a clear and transparent solution state, tolerance to terminal sterilization, and excipient safety, completely resolving inherent defects of the previous generation of foreign "suspension-type" formulations.

Behind this breakthrough lies over two decades of profound industry experience within the founding team. The team possesses full-chain expertise in long-acting formulation development, clinical research, regulatory affairs, and commercialization, providing a solid foundation for technological breakthroughs and rapid commercialization.

As Qingpu Biotechnology accelerates clinical research and global layout across multiple innovative pipelines, the company is steadfastly advancing toward its goal of becoming a "globally influential leader in analgesic new drugs."

Earlier this year, the company signed an exclusive domestic commercialization cooperation agreement for Putanning® with China Biotech Pharmaceutical and its subsidiary Beijing Tide Pharmaceutical. Meanwhile, core invention patents for Putanning® have entered multiple countries worldwide through the Patent Cooperation Treaty (PCT) route and have been granted in China, the United States, Japan, and several other nations.

In terms of commercialization progress, since shipments began in June this year, Putanning® has received positive market feedback and achieved strong sales performance. Xu Bin stated: "We will accelerate the listing of the drug in all provinces, hoping to bring this world-leading analgesic new drug to every patient and medical professional in need of long-acting, potent pain relief."

The analgesic drug sector is regarded as a massive "golden track." According to industry analysis, the Chinese pain management market is expected to reach RMB 50 billion with a compound annual growth rate of approximately 20%, while the U.S. market exceeds USD 30 billion, demonstrating substantial clinical demand and growth potential.

Looking to the future, Qingpu Biotechnology has established a clear development path: focusing on pain management new drugs, the company will achieve cash flow balance and self-sufficiency through the long-acting pathway of its first-launched product to support sustainable operations. Building on this foundation, the company will gradually expand into more challenging First-In-Class drug R&D across various pain indications.

Even amid the recent "capital winter" in the biomedical sector, Qingpu Biotechnology has successfully completed multiple financing rounds against the trend, winning continued investment from renowned institutions including Nanjing Innovation Investment Group, Legend Capital, Matrix Partners China, and Yi 达 Capital. This achievement is attributed to its clear strategic positioning, robust R&D pipeline, and advanced technological platforms.

A relevant person in charge of the Third Investment Department of Nanjing Innovation Investment Group commented: "Qingpu Biotechnology is one of the earliest Biotech companies in China to focus on the pain management field. Its R&D direction of non-opioid analgesics aligns with global clinical needs. The company has efficiently achieved multiple breakthrough milestones in China, initially demonstrating strong capabilities in project initiation, R&D, and Sino-US regulatory filings. As several products are expected to be approved and launched in the coming years, we look forward to the company further expanding its commercialization capabilities, continuously breaking through R&D technological barriers, and delivering more exceptional solutions to address clinical pain management challenges."

Pain is humanity's most primitive shared experience, yet it has long been an overlooked clinical need in medical history. Guided by its mission to "free life from pain," after eight years of perseverance and dedication, Qingpu Biotechnology is ushering in a new era of pain management—one marked by both scientific breakthroughs and humanistic impact.