Looking back at 2014, it was the eve of China’s golden age of innovative drugs. At that time, regulatory reforms for drug approval were in the offing, and the capital market had only a superficial understanding of biotechnology. Even though a cohort of returnee scientists had returned to China to launch startups, the wave of innovative drug development was still in the making, with the future of China’s innovative drug sector remaining ambiguous.

It was in this uncertain climate that Kang Xiaoqiang perceived an irreversible trend: For a major country that had already addressed its people’s basic needs for food, clothing, shelter, and transportation, demand for healthcare was bound to surge dramatically.“Innovative drugs were destined to take off—we just couldn’t pinpoint the exact timing of their breakout,” he recalled. “That’s why we chose to get in early and wait for the tide.”

This “waiting for the tide” was by no means a passive strategy. In his view, uncharted territory meant lower competitive pressure and reduced costs of trial and error—a precious window of opportunity for startup companies. Therefore, the top priority for Leads Biolabs at its founding was not to rush into chasing hot trends, but to clarify exactly what it wanted to do, and more importantly, what it would not do.

This foundational question was soon put to its first practical test.

Back then, the global pharmaceutical industry was abuzz with the advent of PD-1 inhibitors. In 2014, BMS’s Opdivo and Merck’s Keytruda received regulatory approval one after another, completely rewriting the rules of cancer treatment and bringing a hundred-billion-dollar market into clear view.

As expected, savvy domestic biopharma companies swarmed into this space. Kang Xiaoqiang’s team initially planned to develop a PD-1 antibody, but they soon discovered that more than 20 Chinese companies were already laying out their R&D pipelines for this target.

“We made an immediate decision to abandon the plan,” Kang said without hesitation. “The market didn’t need another biotech jumping on the PD-1 bandwagon—that was never our battlefield.”

So where lay their new battlefield? Kang turned his attention to the untapped niche overshadowed by the spotlight of PD-1.

Data showed that the overall response rate of PD-1 inhibitors in cancer treatment was a mere 20%—meaning a staggering 80% of cancer patients could not derive significant benefits from PD-1 therapies. Kang reasoned: If PD-1 was to be the cornerstone of cancer treatment over the next decade, then Leads Biolabs, as a startup, should focus on solving the unmet medical needs that PD-1 failed to address.

This strategic philosophy of complementing PD-1 rather than following its trend has since underpinned all of Leads Biolabs’ pipeline development decisions. Kang expressed profound gratitude for this choice: “If we had jumped on the PD-1 bandwagon back then, I truly wouldn’t know how to navigate our way forward now.”

Based on this strategy, Leads Biolabs has built a research and development (R&D) pipeline comprising approximately 14 drug candidates, 7 of which have entered clinical stages. These pipelines mainly focus on three cutting-edge directions: bispecific antibodies, T-cell engagers (TCEs), and antibody-drug conjugates (ADCs).

The core essence of Leads Biolabs' R&D strategy lies in tackling diseases that are unresponsive to existing therapies represented by PD-1/PD-L1 antibodies.

Exemplified by its core product LBL-024 (Vilisixin®, Opatsumumab), this drug is the world's fastest-advancing PD-L1/4-1BB bispecific antibody and the first-in-class globally to enter the pivotal registration clinical stage.

4-1BB is a key co-stimulatory receptor on the surface of T cells, providing the "second signal" that activates T cell proliferation, survival, and function. Activating this pathway can significantly enhance anti-tumor immune responses, and it is regarded as a potential strategy to overcome drug resistance or insufficient response to PD-1 therapies.

However, systemic activation of 4-1BB may trigger severe hepatotoxicity. Thus, hepatotoxicity became the biggest "roadblock" in the development of first-generation 4-1BB agonistic antibodies.

For instance, BMS's Urelumab reported two fatal hepatotoxicity adverse events in clinical studies; while Pfizer's Utomilumab did not exhibit severe toxic side effects, its efficacy was relatively limited both as monotherapy and in combination with Rituximab.

The successive setbacks of these two pharmaceutical giants never wavered Kang Xiaoqiang's resolve. Even as capital chasers shifted their focus from one trend to another during this period, Kang remained steadfast, refusing to waste energy on meaningless "trend-chasing."

He pointed out that 4-1BB has been successfully applied as a co-stimulatory domain in second-generation CAR-T therapies, significantly enhancing T cell expansion and persistence—proving its strong biological activity. The failure of traditional first-generation 4-1BB monoclonal antibodies in clinical trials was mainly due to their systemic and non-specific activation mode.

This non-specific activation is the root cause of hepatotoxicity. When the antibody circulates systemically, it activates myeloid cells such as Kupffer cells (which highly express 4-1BB in the liver), triggering inflammation and damaging hepatocytes, leading to severe dose-limiting toxicity.

Therefore, Kang firmly believes that the key to the problem lies not in the target itself, but in "how to use it."

LBL-024 adopts a unique 2:2 symmetric structure, and its affinity for PD-L1 is designed to be approximately 300 times that for 4-1BB. This sophisticated design means the drug must first bind to PD-L1 (highly expressed on tumor cells) to effectively cross-link and activate 4-1BB on T cells locally, thereby strictly confining the agonistic effect to the tumor microenvironment. In principle, this avoids off-target activation of normal tissues such as the liver and significantly reduces the risk of hepatotoxicity.

This design is highly ingenious. Acasunlimab, a PD-L1/4-1BB bispecific antibody developed by Genmab (which is also in an advanced stage of development), adopts a different 1:1 structure without weakening the affinity for 4-1BB. However, due to limited efficacy, this drug—already in Phase III clinical trials—was recently discontinued.

In August 2025, the single-arm pivotal registration clinical trial of LBL-024 monotherapy for extrapulmonary neuroendocrine carcinoma (EP-NEC) completed full patient enrollment. As of November 2025, among 45 efficacy-evaluable patients, the Objective Response Rate (ORR) reached 33.3%, the Disease Control Rate (DCR) was 51.1%, and there was a significant tail effect, with patients continuing to benefit after treatment. The Overall Survival (OS) was twice that of existing therapies.

In first-line treatment of EP-NEC in combination with chemotherapy, among 52 efficacy-evaluable patients, the ORR across all dose levels was 75.0%, and the DCR was 92.3%. The ORR in the 15mg/kg dose group reached 83.3%, which was significantly superior to all current treatment regimens. Patients continued to benefit after chemotherapy: 3 patients achieved a Progression-Free Survival (PFS) of more than 12 months, and 1 patient exceeded 15 months. PFS and OS data are not yet mature, and are expected to show a tail effect similar to that of monotherapy.

To date, in addition to EP-NEC, the indications under investigation for LBL-024 have covered 9 cancer types, including small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), and melanoma.

According to data disclosed by Leads Biolabs at its R&D Day in November 2025, the overall ORR of combination therapy as first-line treatment for SCLC was 86.5%, and the DCR was 96.2%. OS data are not yet mature, and the duration of patient benefit continues to extend. For NSCLC treatment in combination with chemotherapy, the data after the first tumor assessment were already striking: the overall ORR was 50%, and the DCR was 94.4%. Notably, the ORR was 75% in immunotherapy-pretreated second-line non-squamous NSCLC, and 67% in PD-L1-negative (TPS < 1) first-/second-line non-squamous NSCLC, warranting focused attention.

Leads Biolabs' R&D landscape extends far beyond LBL-024. Under the core strategy of "addressing the limitations of PD-1 therapy," the company has conducted multi-path parallel exploration and built a synergistic and complementary product matrix.

For example, LBL-034 is a bispecific T-cell engager (TCE) targeting GPRC5D and CD3. It directly "links" T cells to tumor cells to guide T-cell-mediated killing, with a mechanism of action independent of the PD-1 pathway. As one of Leads Biolabs' major products, LBL-034 not only exhibits potent anti-tumor activity but also boasts favorable safety profiles. Off-target toxicity is an unavoidable challenge for GPRC5D-targeted therapies. A large number of multiple myeloma (MM) patients cannot tolerate the oral, skin, and nail toxicities caused by long-term use of Talquetamab (the only approved GPRC5D×CD3 bispecific antibody), restricting its clinical application to MM patients who have failed or are unresponsive to BCMA-targeted therapies. Clinical studies showed that no dose-limiting toxicity was observed for LBL-034 even when the dose was escalated to 1200μg/kg, and the maximum tolerated dose was not reached. Adverse events closely related to quality of life were all Grade 1-2, and almost all occurred in the first cycle, with a significant decrease in incidence in subsequent treatments. The incidence of taste, skin, and nail toxicities was low and showed a tendency for spontaneous resolution. Most treatment-related adverse events did not affect treatment continuity. This favorable safety profile not only lays the foundation for its subsequent advancement to first-line treatment but also expands its clinical application scenarios.

"True innovation must be one-of-a-kind," said Kang Xiaoqiang. This phrase serves as the criterion for all pipeline projects at Leads Biolabs. "Every time I initiate a project, thinking of this sentence clarifies the direction for me."

This commitment to "uniqueness" drives them to continuously explore the deep waters of immunotherapy, tackling what no one has done before while truly solving unmet medical needs.

For a biotech company, the realization of scientific vision cannot be separated from cooperation with capital. Kang Xiaoqiang holds a unique perspective on this: he regards financing as a "perception based on experience" rather than an exact scientific calculation. Its core strategy can be summed up as "counter-cyclical layout."

"You can't wait for the market to heat up before taking action—it will be too late by then," Kang pointed out. The trough of a cycle rarely lasts more than five years, and when bubbles are squeezed out and valuations return to rationality, it is precisely the best window for high-quality companies to stock up on resources and build momentum for the future.

The Series C financing in 2021 is a classic illustration of this philosophy.

At that time, the primary biopharmaceutical market was still in a frenzy, and Leads Biolabs originally planned to raise 300 million yuan. However, Kang realized that market sentiment had reached its peak. "I felt the bubble might burst," he immediately decided to double the financing amount, raising 607 million yuan in one go.

Facts have proven that this was a crucial financing decision. Shortly after the financing was completed, the global biopharmaceutical industry entered a capital winter, and numerous companies with previously high valuations fell into financing difficulties. Thanks to sufficient cash flow, Leads Biolabs was able to focus unswervingly on advancing clinical research of core pipelines such as LBL-024, smoothly navigating the cycle.

The same logic was applied to its IPO. Instead of rushing to list at the height of market sentiment, Leads Biolabs launched its IPO plan during the market downturn in 2024.

Having made preparations in advance, when the market showed signs of recovery in 2025, Leads Biolabs successfully rang the bell at the peak of market enthusiasm. In July 2025, Leads Biolabs was listed on the Hong Kong Stock Exchange, attracting over HK$300 billion in subscription funds, with its stock price surging by more than 127% at one point on its debut.

Talking about the future, Kang stated that the top priority is to submit the first Biologics License Application (BLA) for LBL-024 in 2026. Subsequently, other projects in the pipeline will enter late-stage clinical trials and application phases in a phased manner. "I hope that in the next three to five years, we can launch two to three products while advancing more than a dozen projects in different clinical stages."

As for a longer-term vision, Kang expressed his hope to build Leads Biolabs into "China's Regeneron," and through efforts, turn cancer into a manageable chronic disease in the future.

Looking back on his journey, Kang's biggest insight is "don't think too much about money." In his view, excessive focus on valuations and stock price fluctuations will disrupt the most valuable focus of scientists and entrepreneurs. "My idea is simple: just focus on doing well what is scientifically correct and clinically needed right now. Everything else will fall into place naturally."

Amid the turbulent waves of biotechnology, this almost "insensitive" focus may be the ultimate answer to how Leads Biolabs has navigated cycles and found new routes in uncharted territories.