Nanjing Leads Biolabs Seeks HK$1.1 Billion IPO Amid Biotech Sector Turbulence – Is This a Buy?

The biotech sector has faced heightened volatility in 2025, with investors scrutinizing clinical trial outcomes and regulatory headwinds. Against this backdrop, Nanjing Leads Biolabs Co., Ltd. (维立志生物) is preparing to list on the Hong Kong Stock Exchange, seeking to raise HK$1.1 billion to fund its ambitious pipeline of immuno-oncology therapies. The company's focus on addressing unmet medical needs in rare cancers and its proprietary bispecific antibody technology positions it as a potential standout in a crowded space—but risks remain. Here's why investors should pay attention.

A Spotlight on Unmet Needs: The LBL-024 Catalyst

At the core of Leads Biolabs' value proposition is LBL-024, a first-in-class bispecific antibody targeting PD-L1 and 4-1BB. Designed to treat extrapulmonary neuroendocrine carcinoma (EP-NEC), a rare and aggressive cancer with limited treatment options, LBL-024 has already delivered promising results. In a phase Ib/II trial, the drug achieved a 75% overall response rate (ORR) and 92.3% disease control rate (DCR) in combination with chemotherapy—far exceeding historical benchmarks for chemotherapy alone.

The drug's success has drawn regulatory attention: it secured China's NMPA Breakthrough Therapy Designation in October 2024 and U.S. FDA Orphan Drug Designation in November 2024. These designations could fast-track approvals, creating a near-term catalyst for the stock. With a pivotal Phase III trial underway in China for first-line EP-NEC, LBL-024's success here could validate the company's bispecific platform and unlock a market with no approved therapies.

Beyond NEC: A Diversified Pipeline

While LBL-024 is the crown jewel, Leads Biolabs' pipeline stretches across multiple oncology indications. Its bispecific antibodies and ADCs are being tested in solid tumors like small cell lung cancer (SCLC), ovarian cancer, and gastric cancer, as well as hematologic malignancies like multiple myeloma. Key programs include:
- LBL-007: A LAG-3 inhibitor showing a 33.3% ORR in nasopharyngeal carcinoma (NPC), a cancer prevalent in Southeast Asia.
- LBL-034: A CD3/GPRC5D bispecific targeting relapsed multiple myeloma, leveraging the LeadsBody™ platform for T-cell engagers.

The company's X-Body™ and LeadsBody™ platforms are critical to its competitive edge. These proprietary systems enable the design of bispecific antibodies with optimized affinity ratios, reducing toxicity while boosting efficacy—a technical hurdle many peers have struggled to overcome.

Strategic Alliances and Global Ambition

Leads Biolabs isn't siloed in China. Its partnership with U.S.-based BiOneCure Therapeutics combines ADC expertise, pairing Leads' antibodies with BiOneCure's payload-linker technology. This collaboration could accelerate progress in solid tumors, a market projected to reach $22 billion by 2030. Additionally, its joint venture with Oblenio Bio (2024) signals a push into AI-driven drug discovery—a strategic move to stay ahead of rivals.

Valuation and Risks: High Reward, High Stakes

The IPO aims to raise funds for clinical trials, R&D, and manufacturing scale-up. While the exact use of proceeds isn't disclosed, the company's $163 million in prior financing rounds (including a Series C1 in late 2024) suggests a valuation in line with peers like BeiGene or Innovent Biologics, which trade at ~5x revenue.

Risks are significant, however:
1. Clinical Trial Outcomes: LBL-024's Phase III results could miss expectations, derailing near-term growth.
2. Regulatory Hurdles: Even with designations, navigating global approvals in markets like Europe or the U.S. remains uncertain.
3. Competition: ADCs and bispecifics are hot spaces; companies like Roche and Genentech are advancing similar programs.
4. Market Volatility: Biotech stocks are sensitive to macroeconomic shifts; a prolonged bear market could pressure valuations.

The Bottom Line: A High-Reward Opportunity with a Catalyst

Leads Biolabs' focus on underserved cancers and its proprietary tech give it a defensible niche. If LBL-024 wins approval for EP-NEC—a disease with no approved therapies—it could carve out a lucrative revenue stream while validating its bispecific platform for broader applications.

Investment Takeaway: The IPO offers a chance to bet on a company with a clear near-term catalyst and a pipeline targeting high-value niches. However, investors should wait for a post-IPO pullback to ~$10/share (assuming a $500M valuation) before considering entry. Monitor LBL-024's Phase III readout in early 2026 for confirmation of its potential.

In a sector where execution is everything, Leads Biolabs' track record of advancing therapies from lab to clinic undercuts some risk—but the path to success remains littered with pitfalls. For those willing to take a calculated bet on immuno-oncology's next frontier, this IPO is worth watching closely.