On August 19, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) reported that clinical data from a Phase II study evaluating novel TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in combination with PD-L1 monoclonal antibody (mAb) tagitanlimab for the first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) have been published in Nature Medicine (Impact Factor: 58.7) (Press release, Kelun, AUG 19, 2025, View Source [SID1234655381]).

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The publication highlighted initial findings from the Phase II OptiTROP-Lung01 study, evaluating the efficacy and safety results of sac-TMT in combination with tagitanlimab as a first-line treatment of advanced or metastatic NSCLC patients without actionable genomic alterations. The study was led by Prof. Zhang Li’s team at the Center for Cancer Prevention and Control, Sun Yat-sen University, China. Patients in Cohort 1A received sac-TMT (5 mg/kg, Q3W) plus tagitanlimab (1200 mg, Q3W) in a three-week cycle, while patients in Cohort 1B were treated with sac-TMT (5 mg/kg, Q2W) plus tagitanlimab (900 mg, Q2W) in a four-week cycle. Patients received sac-TMT in combination with tagitanlimab in a non-randomized manner until disease progression or unacceptable toxicity. Median follow-ups for Cohort 1A and Cohort 1B were 19.3 months and 13.0 months, respectively (Data cutoff date: May 27, 2024).

The study results demonstrated promising anti-tumor activity, and manageable safety of sac-TMT in combination with tagitanlimab as a first-line treatment for advanced or metastatic NSCLC patients. A total of 40 patients in Cohort 1A and 63 patients in Cohort 1B were included in the full analysis set (FAS) for efficacy assessment. In Cohort 1A and Cohort 1B, respectively, the confirmed objective response rates (ORRs) were 40.0% (95% CI: 24.9–56.7) and 66.7% (95% CI: 53.7–78.0), and the ORRs were:

44.4% and 64.7% among patients with non-squamous carcinoma, 36.4% and 69.0% with squamous carcinoma;
41.7% and 57.1% among patients with PD-L1 tumor proportion score (TPS) <1%;
38.5% and 63.2% for TPS 1–49%;
40.0% and 78.3% for TPS ≥50%.
The median progression-free survival (mPFS) for Cohort 1A was 15.4 months (95% CI: 6.7–17.9) and not reached (95% CI: 9.6–NE) for Cohort 1B.

The most common grade ≥3 treatment-related adverse events (TRAEs) for both Cohorts 1A and 1B were decreased neutrophil count, decreased white blood cell count and anemia. No treatment-related deaths were observed.

Subgroup analyses showed consistent efficacy across PD-L1 and TROP2 expression levels, as well as in both squamous and non-squamous histological subtypes.

Dr. Michael Ge, CEO of Kelun-Biotech, commented: "The OptiTROP-Lung01 study supports the promising efficacy and safety of sacituzumab tirumotecan in combination with tagitanlimab as a first-line treatment for patients with advanced NSCLC. The results were observed across PD-L1/TROP2 expression levels and histological subtypes and support the advancement potential of sac-TMT from later-line to front-line therapy. The publication of results from several studies in top-tier international journals reflects the recognition of our innovation-driven development strategy. We will continue to work to address critical clinical challenges and unmet medical needs, striving to deliver more therapeutic options and improve quality of life for patients."

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 14 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab[1] or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab

Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

On August 19, 2025 WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) service company offering end-to-end solutions for biologics discovery, development and manufacturing, reported its unaudited interim results for the first half of 2025 ("Reporting Period").

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Financial Highlights

Revenue: The Group’s revenue for the Reporting Period increased by 16.1% YoY to RMB9,953.2 million. The growth was primarily driven by: (i) the continued success of the Group’s "Follow and Win the Molecule" strategies, supported by its leading technology platforms, best-in-industry timelines and strong execution record; (ii) an expanded range of services offered across the biologics value chain – including discovery, pre-IND development, and clinical and commercial manufacturing – with notable momentum in fast-growing platforms such as antibody-drug conjugates (ADCs), and bi- & multi-specific antibodies; (iii) growth in research services revenue, underpinned by the Group’s cutting-edge technologies; and (iv) increased utilization of both existing and newly expanded capacity, including the ramp-up of the Group’s manufacturing facility in Europe.

Gross Profit and Gross Profit Margin: IFRS gross profit increased 27.0% YoY to RMB4,252.9 million, while adjusted gross profit rose 19.2% YoY to RMB4,543.4 million. IFRS gross profit margin reached 42.7%, with adjusted gross profit margin at 45.6%. The improvement in gross profit margin was primarily driven by favorable volume and mix, enhanced efficiency and process optimization achieved through the Group’s WBS and digitalization initiatives.

EBITDA and EBITDA Margin: EBITDA grew 50.5% to RMB4,221.8 million, while adjusted EBITDA increased 20.6% YoY to RMB4,305.2 million. EBITDA margin reached 42.4%, and adjusted EBITDA margin expanded to 43.3%.

Net Profit and Net Profit Attributable to Owners of the Company: IFRS net profit rose 54.8% YoY to RMB2,756.6 million, while net profit attributable to owners of the Company grew 56.0% to RMB2,339.3 million. This growth was primarily driven by higher gross profit, the gains from the Group’s investment and asset divestiture activities.

Adjusted Net Profit: Adjusted Net Profit for the period increased 11.6% YoY to RMB2,840.0 million, with an adjusted net profit margin of 28.5%.

Basic Earnings Per Share (EPS): Basic EPS rose 56.8% from RMB 0.37 for the six months ended June 30, 2024 to RMB 0.58 for the six months ended June 30, 2025. Diluted EPS increased by 57.1% from RMB 0.35 to RMB 0.55 over the same period.

(Press release, WuXi Biologics, AUG 19, 2025, View Source [SID1234661836])

On August 19, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, reported that its in-house discovered CLDN18.2 ADC, ATG-022,was granted a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of CLDN18.2-positive, HER-2 negative unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) in patients who have received at least two prior lines of therapy (Press release, Antengene, AUG 19, 2025, View Source [SID1234655382]).

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The Breakthrough Therapy designation, introduced by the NMPA, is a key initiative aimed at accelerating the development and approval of innovative medicines that offer significant clinical benefits. With this designation, ATG-022 will receive priority review resources, reducing the overall research and development timeline and enabling faster access for patients in China. This follows the U.S. Food and Drug Administration’s (FDA) granting of Orphan Drug Designation (ODD) to ATG-022 for the treatment of gastric and pancreatic cancers, highlighting its strong clinical potential across multiple tumor types.

In the ongoing CLINCH Phase I/II clinical study, data show that ATG-022 demonstrated significant antitumor activity and a favorable safety profile in patients with gastric or gastroesophageal junction adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels.

CLDN18.2 Moderate-to-high expression (IHC 2+ > 20%)
2.4 mg/kg Cohort
Objective Response Rate (ORR): 40% (12/30), including 1 Complete Response (CR)
Disease Control Rate (DCR): 90% (27/30)
Median Progression-free Survival (mPFS): 6.97 months
6-month PFS Rate: 51.1%
9-month Overall Survival (OS) Rate: 82.7%
12-month OS Rate: 66.2%
1.8 mg/kg Cohort
ORR: 40% (10/25), including 1 CR
DCR: 84% (21/25)
CLDN18.2 Low and Ultra-low expression (IHC 2+ ≤ 20%)
Efficacious dose range of 1.8-2.4 mg/kg
ORR: 33.3% (6/18), including 1 CR
DCR: 50% (9/18)
Notably, some responding patients had CLDN18.2 expression levels below 5%, underscoring the robust antitumor activity of ATG-022 in both low- and ultra-low-expression populations.
To date, three patients in the study have achieved CR during treatment, with one case observed in each of the three aforementioned cohorts (i.e., both dose levels in the CLDN18.2 moderate-to-high expressor cohorts and the CLDN18.2 low and ultra-low expressor cohort). This broad-spectrum antitumor activity positions ATG-022 as a potential new treatment option for a wider patient population compared with other CLDN18.2-targeted therapies.

Antengene is currently conducting the Phase II dose-expansion stage of ATG-022 in the Mainland of China and Australia, with the program now entering mid-to-late stage of clinical validation. The company will continue to advance the clinical development of ATG-022 in gastric cancer while exploring its potential in other CLDN18.2-positive tumors. For gastric cancer indications, the development strategy spans first- through third-line treatment:

First-line treatment (CLDN18.2 IHC 1+ ≥1%, PD-L1 CPS ≥1%): ATG-022 in combination with pembrolizumab and chemotherapy (CAPOX/FOLFOX)
Second-line treatment (CLDN18.2 IHC 1+ ≥1%, PD-L1 CPS ≥1%): ATG-022 in combination with pembrolizumab
Third-line treatment (CLDN18.2 IHC 2+): ATG-022 monotherapy, covering patients across different CLDN18.2 expression levels, including CLDN18.2 moderate-to-high expressor (2+ >20%), and low and ultra-low expressors (2+ ≤20%)
In addition, the ongoing Phase II study includes a basket trial cohort covering multiple tumor types. In a certain subtype of gynecologic tumor, all 7 patients who had undergone at least one efficacy assessment demonstrated tumor shrinkage, indicating significant clinical potential for ATG-022 in other CLDN18.2-positive tumors. This cohort remains open for enrollment and follow-up, and the continued data generation is expected to further strengthen the robust value proposition of ATG-022 across multiple tumor types.

On August 19, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the"Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors (Press release, ALX Oncology, AUG 19, 2025, View Source [SID1234655368]).

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"Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026."

The Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial.

ALX2004: Optimized for Success Based on Rigorous Drug Design Process

Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload.

Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class

Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile.

On August 19, 2025 Following the announcement of its foundational U.S. patent allowance, Ategenos reported its investigational SmartPatch platform — a first-of-its-kind connected system in development to wirelessly detect and address medication non-adherence (Press release, Ategenos Pharmaceuticals, AUG 19, 2025, View Source [SID1234655383]). The public debut follows over three years of work in stealth mode advancing the technology toward future clinical evaluation and regulatory review.

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Built on the company’s now-patented innovations, Ategenos SmartPatches contain reformulated oral solid dose (OSD) blockbuster drugs in a connected, transdermal SmartPatch that delivers sustained-release therapy over multiple days, while also detecting missed doses and automatically alerting caregivers to make interventions.

This marks the first time a drug delivery system has combined passive drug administration with active, cloud-connected intelligence, aiming to reduce the estimated $528.4 billion in U.S. healthcare costs ($1T globally) driven by medication non-adherence.

"We’re building a new layer of intelligence into the fabric of pharmacotherapy," said Don DeGolyer, CEO of Ategenos. "When medications go untaken, it’s not just dollars lost. It’s people’s lives unraveling through preventable relapses, hospital stays, and declining independence. Our SmartPatches enable early interventions, giving patients a better chance to stay well, at home, and in control of their lives."

A new vision for smart therapeutics, the Ategenos SmartPatch platform is being designed to deliver:

Next-generation transdermal drug delivery with multi-day sustained release
Integrated, low-cost, self-powered disposable electronics that connect wirelessly to Internet-of-Things community networks and a secure healthcare cloud
AI-powered reminders and alerts intended to notify caregivers of missed doses, supporting timely interventions that may help prevent hospitalizations
Simple, familiar application designed to be used like any other transdermal patch, with no special handling required to benefit from its planned IoT connectivity
On track to be the first and only solution with direct, real-time measurement of medication non-adherence in community populations
Ategenos is advancing a proprietary drug pipeline through the FDA’s 505(b)(2) regulatory pathway across behavioral health, cardiovascular, CNS, and oncology indications. At the same time, the company is exploring external development partnerships with pharmaceutical manufacturers in three key areas:

Lifecycle extension opportunities for therapies nearing the end of exclusivity
Reformulation of in-development compounds where patient compliance is a known challenge
Real-time, connected alternatives to existing OSD products facing commercial headwinds from non-adherence
Ategenos is partnering with a select group of pharma companies positioned to lead in connected therapeutics. A few strategic partner slots remain for those seeking first-mover advantage with the only scalable platform for connected drug delivery and real-time adherence monitoring.

Ategenos is also engaging select capital and strategic partners aligned with its mission to address the global crisis of medication non-adherence.

The Ategenos SmartPatch platform is an investigational device, currently under development. It has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) and is not available for commercial sale. Any future availability will depend on successful regulatory review and approval.