For innovative drug investors, a major event is on the horizon. This Saturday, September 12th, the 2026 WCLC (World Conference on Lung Cancer) opens its doors, with several leading innovative drug companies like Akeso, CSPC Pharmaceutical Group, and Kelun-Biotech set to unveil clinical data for their core products.

The innovative drug field is marked by a high professional threshold. Whether the upcoming data readouts are bullish or bearish, and how significant their impact will be, remains a key question. To help you quickly grasp innovative drug news and announcements, here is a comprehensive quick-reference checklist of clinical terminology for the sector.

Phase 1: A One-Sentence Summary of Clinical Trial Stages

The clinical logic of innovative drugs can be summed up in one sentence: the higher the trial phase, the closer the drug is to market, and the greater its significance.

Phase I trials are about testing the waters. The focus is on the new drug's safety, tolerability, and pharmacokinetics. The trial population varies by drug type, with traditional chemotherapy drugs typically involving dozens of patients, while modern targeted or immunotherapy drugs may enroll over a hundred.

Phase II trials aim to validate efficacy. They provide preliminary evidence of whether the new drug works and help identify the appropriate dosage. A positive Phase II result signals that the preliminary efficacy signal has passed, providing a basis for advancing to Phase III. This is considered a high-value, positive news event.

Phase III trials are the decisive battle for market approval. They further validate efficacy and safety in cohorts of hundreds or thousands of patients, typically using a randomized, double-blind, controlled design. Reaching the primary endpoint in Phase III significantly boosts the probability of approval, representing a substantial positive catalyst.

Phase IV trials, conducted post-marketing, involve large-scale monitoring of safety, assessing long-term efficacy and rare adverse reactions under widespread use conditions.

Section 2: Core Efficacy Endpoints Explained

OS (Overall Survival) measures the time from randomization to death from any cause. In simple terms, it tracks how long patients live from enrollment. Clinical trials typically report median OS, which is the survival time for 50% of patients. It is the most reliable efficacy endpoint in oncology trials and is considered the ultimate gold standard.

PFS (Progression-Free Survival) measures the time from randomization to objective tumor progression or death. Put simply, it tracks how long a tumor stops growing or worsening after treatment. It often serves as a surrogate endpoint supporting accelerated approval, making it a hardcore metric. A longer PFS indicates stronger tumor control by the drug.

ORR (Objective Response Rate) refers to the proportion of patients whose tumors shrink (with a complete response or partial response that must be maintained for at least four weeks). For example, an ORR of 90% means that 90 out of 100 patients saw significant tumor reduction. It is a direct indicator of a drug's anti-tumor activity, with higher values indicating better efficacy.

DCR (Disease Control Rate) represents the total proportion of patients whose tumors shrink or remain stable. In other words, it counts any patient whose disease does not progress. Since it includes those with stable disease, it is typically higher than ORR.

DOR (Duration of Response) measures the time from the first confirmed response to disease progression or death, indicating how long the response lasts.

DFS (Disease-Free Survival) measures the time from treatment (such as surgery) to disease recurrence or death, often used in adjuvant treatment settings.

Primary endpoints are directly tied to the main trial objective, used for sample size calculations and determining trial success. Secondary endpoints typically support the conclusions drawn from the primary endpoint, with key secondary endpoints potentially supporting benefit claims in drug labels.

A surrogate endpoint is an indicator that predicts clinical benefit but does not directly measure it (such as lab tests or imaging biomarkers). The FDA's accelerated approval pathway allows drugs to be approved based on surrogate endpoints, but confirmatory trials must be completed post-approval.

Section 3: High-Frequency Terms Found in Announcements

IND (Investigational New Drug Application) is a submission to regulatory agencies, such as the FDA in the US or NMPA in China, that must be approved before human clinical trials can begin. Under FDA rules, the IND automatically takes effect if no objections are raised within 30 days of submission.

Target refers to the "target" a drug attacks, typically a protein, gene, or receptor on human cells. Diseases like cancer and hyperlipidemia rely on these molecules to grow and survive. By finding and binding to them, drugs can inhibit the disease process.

A head-to-head trial directly compares a new drug against the current standard of care to demonstrate its superiority (being better than the standard) or non-inferiority (being at least as good). Head-to-head trials aiming for superiority provide the highest level of evidence.

Blinding is a study design element. Single-blinding means participants do not know their group assignment. Double-blinding means neither researchers nor participants know who receives which treatment, representing the gold standard for Phase III trials.

CI (Confidence Interval) adds a "margin of error" to an efficacy estimate. The commonly used 95% CI means the true effect likely falls within this range. Typically, a 95% CI below 1 with a narrow interval indicates a reliable and clear benefit signal.

HR (Hazard Ratio) shows the risk of events like death or progression in the treatment group compared to the control group. An HR below 1, with a confidence interval that does not cross 1, suggests the drug may be effective. Generally, a lower HR indicates a greater reduction in risk.

NDA (New Drug Application) is a marketing application for small-molecule chemical drugs, requiring complete data on chemistry, manufacturing, and controls, pharmacology, toxicology, clinical results, and statistics.

BLA (Biologics License Application) is a marketing application specifically for biologics, such as vaccines, monoclonal antibodies, gene therapy, and cell therapy.

Section 4: Interpreting Recent Domestic Innovative Drug Data

With a handle on the high-frequency terms used in drug R&D, let's apply them to interpret the clinical data recently disclosed by domestic innovative drug companies.

Example 1: Akeso announced on September 3rd the latest results from its HARMONi-2 trial. At a pre-specified interim OS analysis, it successfully achieved the key secondary endpoint of overall survival. Detailed data will be released during WCLC. HARMONI-2 is a Phase III study directly comparing the investigational drug ivonescimab to the current first-line standard of care, pembrolizumab. Interpretation: OS is the gold standard for oncology efficacy. This validates that ivonescimab's benefit has escalated from "delaying disease progression" to "extending patient survival."

Example 2: Chia Tai Tianqing, a subsidiary of Sino Biopharmaceutical, announced that in an interim analysis of its Phase III trial for TQB2102 (a HER2 bispecific antibody-drug conjugate), the drug successfully met its primary and key secondary endpoints in patients with HER2-low expressing recurrent or metastatic breast cancer. Interpretation: Reaching the endpoint in a Phase III trial carries significant weight. The next step is regulatory submission, charting a clear path toward commercialization.

Example 3: CSPC Pharmaceutical Group presented positive results at the 2026 ESC Congress (European Society of Cardiology Annual Meeting) from a Phase II trial of its self-developed PCSK9-targeting siRNA drug, SYH2053 injection. Interpretation: A positive Phase II result represents successful mid-stage key validation, subject to further confirmation in subsequent Phase III trials.

Section 5: Investment Vehicles for the Innovative Drug Sector

In the second half of the year, international academic conferences for innovative drugs will be densely packed. The progress of Phase III clinical development for already-licensed assets, as well as the data delivery of high-quality projects, will be unveiled sequentially. In the secondary market, conference-driven rallies are worth anticipating.

For investors seeking full-chain exposure to innovative drugs, two T+0 trading tools are worth noting. The first is the Hang Seng HK Stock Connect Innovative Drug ETF (520880), which closely tracks the Hang Seng HK Stock Connect Innovative Drug Selection Index. It allocates 100% of its holdings to innovative drug R&D companies, with 70% of positions focused on R&D leaders. Its off-exchange feeder fund is 025221.

The second is the HK Stock Connect Healthcare ETF (159137), which tracks the HK Stock Connect Healthcare Theme Index with a heavy focus on the innovative drug supply chain. Its allocation is 55% CXO and 20% innovative drugs, with WuXi-related companies accounting for over 39%. Its off-exchange feeder fund is 026922.

Data source: Public information from the Shanghai and Shenzhen Stock Exchanges, Hong Kong Stock Exchange, CSI Index Company, Hang Seng Index Company, among others. Weight data is as of August 31, 2026. Fund fees: ETF funds do not charge sales service fees. When investors subscribe or redeem fund shares, the authorized broker may charge a commission of up to 0.5%, which includes fees charged by securities exchanges and registration institutions. For detailed fees, please refer to each fund's legal documents.

Special note: The fund manager has assessed the risk level of the HK Stock Connect Healthcare ETF, the HK Stock Connect Innovative Drug ETF, and their feeder funds as R4 (medium-to-high risk), suitable for aggressive investors (C4) and above.

Risk warning: The index constituents mentioned in this article are for display purposes only. Descriptions of individual stocks do not constitute investment advice in any form, nor do they represent the holdings or trading activities of any fund managed by the fund manager. The weight of the mentioned stocks in the Hang Seng HK Stock Connect Innovative Drug Selection Index is shown in the accompanying chart. Any information appearing in this article (including but not limited to individual stocks, comments, forecasts, charts, indicators, theories, and any forms of expression) is for reference only. Investors must bear full responsibility for their own investment decisions. Furthermore, any opinions, analysis, or forecasts in this article do not constitute investment advice of any form to readers, and the author assumes no liability for any direct or indirect losses arising from the use of this content. The performance of other funds managed by the fund manager is not a guarantee of this fund's performance; past performance does not represent future results. Fund investment carries risks.