Kelun-Biotech advances SKB118 in China as PD-1 x VEGF race intensifies

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) has received Investigational New Drug approval from China’s Center for Drug Evaluation for SKB118, a PD-1 x VEGF bispecific antibody being developed for advanced solid tumors. The approval allows Kelun-Biotech to move SKB118 into clinical development in China while Crescent Biopharma continues the global ASCEND Phase 1/2 trial of the same candidate, also known as CR-001. The development matters because PD-1 x VEGF bispecific antibodies have become one of the most closely watched next-generation immuno-oncology classes, with investors looking for assets that can improve on checkpoint inhibitor outcomes without creating unacceptable toxicity. Kelun-Biotech’s Hong Kong-listed shares have recently traded around the mid-HK$450 range, giving the company a market value above HK$100 billion and showing that investors are already pricing in substantial pipeline expectations, not just near-term commercial execution.

Why does Kelun-Biotech’s SKB118 China IND approval matter for the PD-1 x VEGF bispecific antibody market?

The China IND approval for SKB118 is strategically important because it moves Kelun-Biotech from regional rights-holder into an active clinical participant in one of oncology’s most competitive development lanes. SKB118 combines blockade of PD-1, a checkpoint pathway used by tumors to escape immune detection, with inhibition of VEGF, a pathway linked to tumor angiogenesis and abnormal blood vessel formation. In plain English, the candidate is designed to attack the tumor from two directions: restoring immune recognition while disrupting the vascular environment that helps cancer grow and evade treatment.

That dual-mechanism approach is not new in oncology, but putting both functions into a single bispecific antibody is what makes the category commercially and clinically interesting. The success of checkpoint inhibitors changed cancer treatment, but many solid tumor patients still fail to respond or develop resistance. VEGF inhibition has long been used in solid tumors, yet combining anti-angiogenic therapy with immunotherapy through separate drugs can increase complexity, cost, and toxicity management. A single molecule that brings both mechanisms together could offer development advantages if it shows cleaner dosing, stronger tumor-site activity, or better combination potential.

For Kelun-Biotech, the approval also gives the company a timely entry into a field already shaped by Akeso Biopharma’s ivonescimab and other global programs. That is both opportunity and pressure. The opportunity is that PD-1 x VEGF biology has already attracted serious regulatory, clinical, and licensing attention. The pressure is that SKB118 must eventually show it has a differentiated profile, not merely a familiar target combination with a new asset code attached. In biotech, “me too” is not a strategy. It is an invitation to be discounted.

How does the Crescent Biopharma partnership change Kelun-Biotech’s oncology pipeline strategy in Greater China?

Kelun-Biotech’s partnership with Crescent Biopharma gives the Chinese company exclusive rights to research, develop, manufacture, and commercialize SKB118 in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan. That structure is significant because it gives Kelun-Biotech a regional immuno-oncology asset that can be integrated into its broader cancer pipeline rather than developed as a standalone licensing trophy. The company is not simply importing an experimental antibody. It is adding a potential combination backbone for its antibody-drug conjugate portfolio.

The partnership also reflects a broader pattern in cross-border biotech dealmaking. Chinese biopharma companies are no longer only licensing assets outward to global partners. They are increasingly using two-way collaborations to sharpen regional pipelines, share clinical data, and accelerate parallel development across China and international markets. In this case, Crescent Biopharma is advancing CR-001 globally through the ASCEND trial, while Kelun-Biotech gains the chance to develop SKB118 inside China’s large and increasingly sophisticated oncology market.

The strategic value for Kelun-Biotech lies in optionality. If global data from Crescent Biopharma’s ASCEND trial begins to show a promising safety and efficacy signal, Kelun-Biotech may be positioned to move faster in China with local development, regulatory planning, and combination studies. If the class becomes more contested or data expectations rise, Kelun-Biotech still gains scientific insight that can inform how it combines immuno-oncology with its existing antibody-drug conjugate assets. Either way, the partnership gives Kelun-Biotech a seat at the PD-1 x VEGF table without requiring it to build every piece of the program alone.

Why could SKB118 become more valuable if Kelun-Biotech combines it with its ADC portfolio?

The most interesting part of the SKB118 approval is not the IND itself. The more important question is whether Kelun-Biotech can use SKB118 to create rational combinations with its proprietary antibody-drug conjugate assets. Kelun-Biotech has built its investment story around oncology innovation, particularly antibody-drug conjugates and novel drug conjugates. SKB118 could fit that platform if its anti-VEGF activity helps normalize tumor vasculature and improve the delivery or localization of combination therapies.

That is the strategic logic behind the company’s stated ADC plus immuno-oncology approach. Antibody-drug conjugates depend on target expression, payload potency, internalization, and tumor penetration. Immuno-oncology agents depend on immune activation and the tumor microenvironment. A PD-1 x VEGF antibody that improves immune activity while reshaping the vascular environment could, in theory, make antibody-drug conjugate combinations more compelling in selected tumors. The scientific hurdle is proving that this theoretical synergy turns into meaningful clinical benefit rather than more complexity.

This is where Kelun-Biotech’s execution will matter. The company will need to choose tumor types carefully, avoid overloading early development with too many combination arms, and identify biomarkers that support patient selection. Investors have become more skeptical of oncology platforms that promise broad applicability without clean clinical prioritization. SKB118 can strengthen Kelun-Biotech’s oncology thesis, but only if the company can show that it adds practical value to the pipeline rather than increasing trial burden.

What does the approval signal about China’s role in next-generation immuno-oncology development?

The SKB118 approval reinforces China’s growing importance in next-generation immuno-oncology, particularly in bispecific antibodies and antibody-drug conjugates. China’s biotech sector has moved from fast-following established Western mechanisms to generating globally relevant clinical assets in areas such as PD-1 x VEGF, TROP2 antibody-drug conjugates, HER2-directed therapies, and novel immune combinations. Kelun-Biotech’s SKB118 program sits directly inside that transition.

For multinational pharmaceutical companies, this shift changes the competitive map. China is no longer only a commercialization geography. It is a clinical innovation market, a licensing source, and increasingly a proving ground for differentiated oncology biology. The rise of PD-1 x VEGF bispecifics is a good example. The category has drawn attention because it could challenge established checkpoint inhibitor combinations if clinical data remain durable and safety remains manageable.

For Chinese developers, however, the bar is rising quickly. Domestic approval to begin trials is only the first step. Global credibility will depend on high-quality data, internationally relevant trial design, and evidence that novel bispecifics can compete with entrenched standards of care. The race is no longer about who can name the mechanism first. It is about who can generate survival data, manage toxicity, secure regulatory alignment, and persuade payers that incremental benefit is worth the cost.

How should investors read Kelun-Biotech stock after the SKB118 China trial clearance?

Kelun-Biotech’s share price already reflects considerable investor confidence in its oncology platform, with the company trading near the upper end of its historical range even after moving below its 52-week high. That makes the SKB118 IND approval supportive rather than transformational for the stock. It adds credibility to the company’s pipeline depth, but it does not yet answer the hard questions around clinical differentiation, commercialization scale, or profitability.

The company’s broader financial profile also matters. Kelun-Biotech reported 2025 revenue growth, a stronger gross profit base, and significant cash and financial assets, but it remains in an investment-heavy phase with continuing losses and large research and development spending. That is not unusual for an innovative oncology company, but it does mean that pipeline expansion must eventually translate into value-creating clinical milestones. Investors will likely reward disciplined prioritization more than sheer program count.

Sentiment around Kelun-Biotech is therefore balanced but demanding. The market appears willing to assign a premium to the company’s ADC capabilities, partnered programs, and global collaboration strategy. However, that premium also raises the burden of proof. SKB118 can support the long-term story, especially if China development runs in parallel with strong global ASCEND data, but early-stage immuno-oncology assets rarely deserve victory laps before dose escalation has done its very unglamorous job.

What happens next for SKB118 as Kelun-Biotech moves toward China clinical development?

The next phase for SKB118 will be defined by clinical design, patient selection, and the degree of alignment between China development and the global ASCEND program. Crescent Biopharma’s ASCEND trial is evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer and gastrointestinal and gynecological cancers. Kelun-Biotech will need to decide how China development can complement that global dataset without becoming duplicative or strategically scattered.

The first near-term test is safety. PD-1 and VEGF are validated mechanisms, but combining them in a bispecific format still requires careful evaluation of immune-related adverse events, bleeding risk, hypertension, vascular complications, and overlapping toxicity in combination settings. The second test is efficacy signal quality. Early response rates can excite investors, but durable benefit, progression-free survival, overall survival, and tolerability will determine whether SKB118 becomes a serious asset or another interesting molecule in a crowded field.

The third test is portfolio fit. Kelun-Biotech has made clear that it wants to explore SKB118 alongside proprietary antibody-drug conjugates. That could be the differentiating angle if the company designs trials around credible biological rationale. It could also become a risk if combination ambitions outrun clinical evidence. The smartest path would be a staged approach, with monotherapy and rational combination data informing each next step rather than using platform breadth as a substitute for proof.

Key takeaways on Kelun-Biotech, SKB118, and the PD-1 x VEGF oncology race

• Kelun-Biotech’s China IND approval for SKB118 gives the company a direct clinical foothold in the fast-moving PD-1 x VEGF bispecific antibody category.
• The approval is strategically meaningful because SKB118 can be developed not only as a standalone immuno-oncology asset but also as a potential combination partner for Kelun-Biotech’s antibody-drug conjugate portfolio.
• The Crescent Biopharma partnership gives Kelun-Biotech Greater China rights while global development continues through the ASCEND Phase 1/2 trial, creating a parallel-data model across major oncology markets.
• The biggest commercial question is whether SKB118 can show differentiation against better-known PD-1 x VEGF programs, especially in tumor types where checkpoint inhibitor combinations are already entrenched.
• Kelun-Biotech’s stock already prices in substantial pipeline optimism, so investors may treat the IND approval as a validating milestone rather than a valuation reset.
• The company’s ADC plus immuno-oncology strategy could become more compelling if SKB118 demonstrates clean safety, tumor-site activity, and rational synergy with drug conjugates.
• China’s role in oncology innovation continues to deepen, with companies such as Kelun-Biotech moving beyond domestic development into globally relevant mechanisms and partnership structures.
• The main risks remain clinical execution, trial prioritization, toxicity management, and the possibility that PD-1 x VEGF enthusiasm becomes crowded before SKB118 reaches decisive data.
• For Kelun-Biotech, the next value inflection will likely come from early clinical safety and efficacy signals rather than the regulatory clearance itself.