ASCO Highlights: Lung Cancer Therapies Show Strong Potential, BGB-43395 Data Positive

Overview

This report reviews several research findings from Chinese pharmaceutical companies unveiled at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, focusing on the latest advancements in lung cancer and breast cancer. Despite current market sentiment being subdued, several companies have achieved encouraging results in key drug clinical trials, suggesting potential for future value realization.

Core views

In lung cancer, Kolon Pharmaceutical’s Sac-TMT combined with pembrolizumab demonstrated outstanding performance in first-line treatment of PD-L1-positive NSCLC, with an objective response rate (ORR) as high as 70.2%, along with progression-free survival (PFS) and overall survival (OS) hazard ratios of 0.35 and 0.55 respectively, showcasing remarkable therapeutic efficacy. Conba Bio’s AK112, a PD-1×VEGF bispecific antibody, achieved significant overall survival benefits in first-line treatment of squamous NSCLC (HR=0.66), marking the first time a drug using this mechanism reached such a milestone. Xinda Bio’s IBI363 is a PD-1×IL-2α biased agonist bispecific antibody that demonstrated durable survival advantages in treated NSCLC patients, particularly among non-adeno-subtype patients, with 24-month overall survival rates of 47.8% (squamous cell carcinoma) and 42.7% (adenocarcinoma). Additionally, B7H3-targeted ADCs developed by Sinopharm and Stone Pharmaceutical Group—SKB500 and SYS6043—showed high response rates (ORRs of 71% and 64%-75% respectively) in second-line and beyond treatment of extensive-stage small cell lung cancer (SCLC), while offering better safety profiles and lower toxicity burdens compared to competitors. In breast cancer, Beda Pharmaceutical’s next-generation CDK4 inhibitor BGB-43395 demonstrated promising prospects in first-line treatment of HR+/HER2- breast cancer, with an ORR of 68% in the 400mg twice-daily dose group, while exhibiting low hematologic toxicity, with a zero incidence of Grade ≥3 neutropenia.

Analysis framework

The research report evaluates the efficacy, safety, and potential competitive positioning of each candidate drug by comparing clinical trial data from different pharmaceutical companies across similar or identical indications. The specific analysis process includes: 1. **Efficacy Comparison**: Based on publicly available clinical trial results, the report calculates and compares core metrics such as objective response rate (ORR), median progression-free survival (mPFS), median overall survival (mOS), and corresponding hazard ratios (HR) for each drug. 2. **Safety Assessment**: The report aggregates adverse event (AE) frequencies associated with each drug, paying particular attention to the occurrence of severe adverse reactions (Grade ≥3 TRAEs) to gauge the drug’s safety window and differences in tolerability. 3. **Market Positioning Analysis**: By considering the competitive landscape and development trends within each drug’s respective market segment, the report predicts the market share and sales potential of candidate drugs in future commercialization efforts. 4. **Historical Data Analysis**: The report draws upon data from past large-scale studies as reference benchmarks, ensuring that the actual improvement in new drug efficacy is accurately reflected.

Methodology notes

• Industry/Industrial Analysis FrameworkVolume vs. Price Breakdown

  By breaking down drug applications across different disease stages, the report estimates market size (TAM) and commercial value.

  This method divides NSCLC into multiple tiers—first-line and second-line and beyond—and assigns specific target population proportions and average treatment costs for each tier, thereby deriving an estimated overall market capacity.

• Valuation MethodPE/PEG valuation

  Utilizing price-to-earnings ratio (PE) and price-to-earnings growth ratio (PEG) to initially assess the intrinsic value of biopharmaceutical companies.

  Although not elaborated in detail in the report, when discussing company fundamentals, PE or PEG metrics may be used to help evaluate whether the stock price is reasonable relative to earnings power and growth rate.

• Fixed Income & Credit AnalysisSpread analysis

  By observing how differences in therapeutic efficacy between drugs lead to market premiums, the report indirectly reflects investors’ expectations regarding future cash flow volatility for these companies.

  When a drug demonstrates significantly superior efficacy compared to competitors, capital markets often pay closer attention, driving up the stock prices of related companies and influencing the spread between their bond yields and other asset classes.

Asset mapping & comparison

Structured mapping from thesis to named assets (strengths, weaknesses, peers, risks).

• Kolon Pharmaceutical (6990.HK)

  Benefiting from positive data in lung cancer treatment with Sac-TMT, it is expected to serve as a key catalyst for restoring the company’s valuation.

  Strengths

  Possesses independent R&D capabilities, has a diversified pipeline, and Sac-TMT has the potential to be a first-in-class therapy.

  Weaknesses

  Lacks sufficient overseas expansion experience, facing challenges in international operations.

  Comparison

  Compared to other domestic Biotech companies, Kolon Pharmaceutical holds a certain leading advantage in ADC platform development.

  Risks

  Risk of late-stage clinical failures or delayed regulatory approvals for Sac-TMT.

• Conba Bio (9926.HK)

  With breakthrough results in lung cancer treatment, AK112 is poised to gain greater market recognition.

  Strengths

  Its dual-antibody platform technology is mature, boasting rapid iterative innovation capabilities.

  Weaknesses

  Over-reliance on a few core products, with a less diversified revenue structure.

  Comparison

  Globally, AK112 is the only product to achieve substantial progress in the PD-1×VEGF bispecific antibody space.

  Risks

  Potential for disappointing results in international multi-center Phase III trials.

• Xinda Bio (1801.HK)

  IBI363’s unique design positions it favorably in specific patient populations, enhancing the company’s long-term growth expectations.

  Strengths

  Strong partner network and rich clinical development experience.

  Weaknesses

  Product portfolio remains relatively concentrated on the PD-1 pathway, lacking sufficient diversity.

  Comparison

  Compared to first-generation PD-1 monoclonal antibodies, IBI363 offers greater responsiveness and longer-lasting effects.

  Risks

  Intensifying market competition for next-generation bispecific drugs could lead to weakened pricing power.

• Beda Pharmaceutical (ONC.US)

  BGB-43395’s success is expected to consolidate the company’s leading position in breast cancer treatment.

  Strengths

  Focused on tumor-targeted small molecule therapies, having cultivated expertise in niche segments for many years.

  Weaknesses

  Slow pace of international expansion, limited efforts in overseas market development.

  Comparison

  BGB-43395’s safety profile outperforms most comparable products, giving it a distinctive competitive advantage.

  Risks

  Risk of failure in expanding additional indications or facing generic drug competition.

Key data

• ORR of Sac-TMT Combined with Pembrolizumab in PD-L1 Positive NSCLC70.2%An increase of nearly 30 percentage points compared to pembrolizumab alone.
• PFS HR of Sac-TMT Combined with Pembrolizumab in PD-L1 Positive NSCLC0.35Indicates a 65% reduction in disease progression risk.
• OS HR of Sac-TMT Combined with Pembrolizumab in PD-L1 Positive NSCLC0.55Suggests a 45% reduction in mortality risk.
• OS HR of AK112 in First-Line Treatment of Squamous NSCLC0.66Statistically significant improvement in overall survival.
• 24-Month OS Rate of IBI363 in Non-Adeno NSCLC Second-Line and Beyond Treatment47.8% (Squamous Cell Carcinoma) / 42.7% (Adenocarcinoma)Far higher than historical control data for traditional chemotherapy regimens.
• ORR of SKB500 in SCLC71%Demonstrated high activity in a limited sample size.
• ORR of SYS6043 in SCLC64%-75%Both dose groups performed strongly.
• ORR of BGB-43395 in First-Line Treatment of HR+/HER2- Breast Cancer in the 400mg BID Dose Group68%Close to the best performance among currently marketed CDK4 inhibitors.
• ORR of BGB-43395 in First-Line Treatment of HR+/HER2- Breast Cancer with Grade ≥3 Neutropenia0%Reflects good bone marrow suppression safety profile.

Impact & implications

These research findings not only enhance understanding of companies’ R&D capabilities in their respective focus areas but also provide strong support for subsequent clinical advancement. Especially in the context of prevailing market pessimism, outstanding clinical data can help boost investor confidence and encourage capital inflows. However, it’s important to note that most drugs are still in early or mid-stage trials, requiring time to validate before formal approval for market launch, and they face intense competition from other market players.

Risks

• Clinical trial results fail to replicate earlier successes, leading to stalled product development.
• Extended regulatory approval processes may impact the timeline for new product launches.
• Competitors are launching similar products one after another, increasing market competition.
• Deteriorating macroeconomic conditions could drag down valuations across the entire biopharmaceutical sector.

What to watch

• Final PFS and OS readouts from AK112’s global Phase III trial HARMONi-3-sq (expected to be released in Q3 2026).
• Updated results from IBI363’s head-to-head comparison trial of pembrolizumab combined with chemotherapy.
• Regulatory filing progress for Sac-TMT in the U.S. market and the level of support from its partner Merck.
• First human trial data for BGB-43395’s oral formulation disclosed at the ADA Congress.