On October 22, 2026 AstraZeneca reported the US availability of ZEGFROVY (sunvozertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.1

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The US Food and Drug Administration granted accelerated approval to ZEGFROVY based on results from the WU-KONG1B trial.2 In the open-label, dose randomization clinical trial, ZEGFROVY demonstrated a confirmed overall response rate of 46% (n=85; 95% confidence interval [CI] 35, 57) and a median duration of response of 11.1 months in those responders (n=39; 95% CI 8.2, NE).1 Seventy-two percent of responding patients (n=39) observed duration of response for at least six months.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

EGFR exon 20 insertion mutations represent a distinct and hard-to-treat form of EGFR-mutated NSCLC.3 Patients have historically had limited targeted treatment options and poor outcomes, with real-world evidence showing a five-year overall survival rate as low as 8%.3

D. Ross Camidge, MD, PhD, Director, Thoracic Oncology, University of Colorado, said: "Patients with EGFR exon 20 insertion-mutated lung cancer have historically had limited targeted treatment options, particularly after their disease progresses following platinum-based chemotherapy.3 For these patients, sunvozertinib (ZEGFROVY) offers an oral, once-daily targeted treatment option that is recommended in clinical practice guidelines – giving patients and clinicians an option when treatment choices have historically been limited.1"

Mohit Manrao, Senior Vice President, US Oncology, AstraZeneca, said: "As a leader in treating EGFR-mutated lung cancer, the US launch of ZEGFROVY marks an important step forward in our commitment to this patient community. People living with EGFR exon 20 insertion-mutated disease have historically had limited targeted treatment options following platinum-based chemotherapy.1 By making ZEGFROVY available in the US, we are bringing an oral, mutation-specific treatment option to a distinct patient population with substantial unmet need.3"

ZEGFROVY can cause severe and life-threatening interstitial lung disease (ILD)/pneumonitis, severe gastrointestinal adverse reactions including diarrhea, nausea, and vomiting, severe rash including acneiform dermatitis and pruritus, ocular toxicity including keratitis, dry eye symptoms, blurred vision, and visual impairment, and fetal harm when administered to a pregnant woman.1

Additionally, a Supplemental New Drug Application for approval in the 1st-line setting, based on Phase III WU-KONG28 trial results presented at last ASCO (Free ASCO Whitepaper), has been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE have also both granted Breakthrough Therapy Designation in this setting.2

Sunvozertinib (ZEGFROVY) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for NSCLC as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines for detailed recommendations.4

ZEGFROVY 200 mg is administered orally once daily with food. The medicine is now available in the US through the ZEGFROVY Specialty Distribution and Pharmacy network.1 The medicine may also be acquired and distributed by Health System’s own-use Specialty Pharmacies.

IMPORTANT SAFETY INFORMATION

Interstitial Lung Disease/Pneumonitis

ZEGFROVY can cause severe and life-threatening interstitial lung disease (ILD)/pneumonitis. In the safety population of 121 patients, ILD/pneumonitis occurred in 1.7% of patients. ZEGFROVY was discontinued due to ILD/pneumonitis in 0.8% of patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, and fever). Immediately withhold ZEGFROVY in patients with suspected ILD/pneumonitis and permanently discontinue ZEGFROVY if ILD/pneumonitis is confirmed.

Gastrointestinal Adverse Reactions

ZEGFROVY can cause severe gastrointestinal adverse reactions including diarrhea, nausea, and vomiting. In the safety population of 121 patients, serious gastrointestinal adverse reactions occurred in 1.7% of patients, including 0.8% Grade 3 nausea. Diarrhea occurred in 73% of patients who received ZEGFROVY, including 2.5% Grade 3. Diarrhea leading to dosage interruption or dose reduction occurred in 5% of patients and required permanent discontinuation of ZEGFROVY in 0.8% of patients. Nausea and vomiting occurred in 43% of patients, including 3.3% Grade 3 events. Nausea and vomiting leading to dosage interruption or dose reduction occurred in 7% of patients and permanent discontinuation of ZEGFROVY in 0.8% of patients. Administer ZEGFROVY with food to reduce gastrointestinal adverse reactions. Monitor patients for gastrointestinal toxicity, and provide supportive care, including anti-diarrheals, anti-emetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity.

Dermatologic Adverse Reactions

ZEGFROVY can cause severe rash including acneiform dermatitis and pruritus. Based on the safety population of 121 patients, dermatologic adverse reactions occurred in 68% of patients including 9% acneiform dermatitis. Grade 3 dermatologic adverse reactions were 7% rash, 0.8% acneiform dermatitis, and 0.8% pruritus. Instruct patients to use alcohol-free (eg, isopropanol-free, ethanol-free) emollient cream during treatment with ZEGFROVY and to avoid the use of irritating skin products (eg, products containing retinol or retinoic acid, benzoyl peroxides). Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity.

Ocular Toxicity

ZEGFROVY can cause ocular toxicity including keratitis, dry eye symptoms, blurred vision, and visual impairment. Based on the safety population of 121 patients, ocular toxicity occurred in 13% of patients who received ZEGFROVY, including keratitis in 0.8% of patients. Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Advise discontinuation of contact lenses until ocular symptoms are evaluated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity.

Embryo-Fetal Toxicity

ZEGFROVY can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of sunvozertinib to pregnant animals during the period of organogenesis resulted in structural abnormalities at concentrations below the human exposure at the recommended dose based on area under the curve (AUC). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose, since ZEGFROVY can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEGFROVY and for 2 weeks after the last dose.

Adverse Reactions

The most common (≥20%) adverse reactions were: diarrhea, rash, decreased appetite, stomatitis, fatigue, nausea, paronychia, vomiting, constipation, musculoskeletal pain, pruritus, dry skin, urinary tract infection, abdominal pain and decreased weight.

The most common (≥2%) Grade 3 or 4 laboratory abnormalities were: decreased lymphocytes, increased lipase, decreased hemoglobin, increased amylase, increased creatine kinase, decreased neutrophils, decreased potassium, increased aspartate aminotransferase, increased alanine aminotransferase, decreased sodium, increased magnesium, and increased alkaline phosphatase.

Drug Interactions

Strong CYP3A Inhibitors: Avoid concomitant use. If concomitant use cannot be avoided, reduce ZEGFROVY dose and monitor for increased ZEGFROVY adverse reactions.

Strong and Moderate CYP3A Inducers: Avoid concomitant use. If concomitant use cannot be avoided, increase ZEGFROVY dose.

Hormonal Contraceptives: Avoid concomitant use. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Concomitant use of ZEGFROVY with CYP3A substrates decreased their plasma concentrations where minimal concentration changes may lead to therapeutic failure of hormonal contraceptives.

Use in Special Populations

Lactation: Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ZEGFROVY and for 2 weeks after the last dose.

Infertility: ZEGFROVY may impair fertility in females and males. The reversibility of the effects on females was not assessed. The effects on male fertility were reversible.

INDICATION

ZEGFROVY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.1

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Please see complete Prescribing Information, including Patient Information for ZEGFROVY.

Notes

EGFR exon 20 insertion-mutated NSCLC

Lung cancer is broadly divided into NSCLC and small cell lung cancer, with NSCLC accounting for approximately 80% to 85% of cases. EGFR exon 20 insertion mutations are a distinct subgroup of EGFR alterations associated with primary resistance to earlier-generation EGFR tyrosine kinase inhibitors and historically limited targeted treatment options. EGFR exon 20 insertions account for an estimated 10% of EGFR-mutated NSCLC cases.1

WU-KONG1B

WU-KONG1B is a multinational, open-label, dose randomization clinical trial that included patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.1 The efficacy population included 85 patients treated with ZEGFROVY 200 mg once daily. The major efficacy outcome measures were confirmed overall response rate and duration of response as assessed by blinded independent central review.

In WU-KONG1B, the confirmed overall response rate was 46% (n=85; 95% CI 35, 57), and the median duration of response was 11.1 months for those responders (n=39, 95% CI 8.2, NE). Among responding patients (n=39), 72% observed duration of response for at least six months.

ZEGFROVY (sunvozertinib)

ZEGFROVY is an oral, irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In the US, ZEGFROVY is approved for the treatment of adults with locally advanced or metastatic NSCLC whose tumors have EGFR exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.1

ZEGFROVY was granted accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

(Press release, AstraZeneca, OCT 22, 2026, View Source [SID1234673688])

On October 22, 2026 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Ticker: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, reported its financial results for the first half of 2026, ended June 30, 2026.

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Philippe GENNE, Chairman and CEO of Oncodesign Precision Medicine, comments: "OPM continues to move towards its therapeutic objective, with two active compounds reaching the clinical proof-of-concept stage in oncology and Parkinson’s disease. There are currently no therapeutic solutions for these conditions, and our role is to successfully overcome this challenge. We can only overcome it if we secure the financial resources required to achieve this goal."

Karine LIGNEL, Deputy CEO and COO of Oncodesign Precision Medicine adds: "Our half-year financial results highlight our meticulous cost management and our constant pursuit of cost savings, while moving forward with our priority programs as far as possible. The support from the Michael J. Fox Foundation has been essential and enables us to continue developing OPM-201, while we have completed preparations for the clinical trial of OPM-101 in immuno-oncology. We are continuing to seek partners to license or sell either of our assets."

Oncodesign Precision Medicine – Income Statement

in €m
Audited data

H1 2026

H1 2025

Change

in %

in value

Revenues

0.11

0.14

-21

%

-0.03

Other revenues and operating income

0.63

0.60

6

%

+0.03

Total revenues and operating income

0.75

0.74

0

%

+0.00

Change in inventory

(0.49

)

13.00

-104

%

-13.49

Purchases consumed

(1.08

)

(2.24

)

-52

%

+1.16

Personnel costs

(0.87

)

(1.51

)

-42

%

+0.64

Other operating expenses

(0.04

)

(0.02

)

54

%

-0.01

Taxes and duties

(0.04

)

(0.03

)

14

%

-0.00

Net change in depreciation, amortization and impairment

(0.39

)

(0.15

)

169

%

-0.25

Total operating expenses

(2.91

)

9.05

na

-11.96

Operating result

(2.17

)

9.79

-122

%

-11.96

Financial expenses and income

(0.16

)

(0.26

)

-40

%

+0.10

Income (loss) from ordinary activities

(2.32

)

9.53

-124

%

-11.86

Non-recurring expenses and income

–

0.00

na

-0.00

Income Tax

0.28

0.31

-10

%

-0.03

Net result

(2.04

)

9.85

na

-11.89

Key financial data

OPM’s revenue amounted to €0.11 million in the first half of 2026, compared with €0.14 million in the first half of 2025. It came primarily from ancillary activities, including the rental of premises and support services provided to the PROMETHE association. No milestone or upfront payments related to development partnerships were expected during the period.

Other revenue and operating income totaled €0.63 million, compared with €0.60 million a year earlier. This amount consists primarily of €0.43 million in operating grants, notably for research programs funded by the Michael J. Fox Foundation and government agencies, as well as €0.19 million from reversals of provisions.

In the first half of 2026, OPM continued the cost-reduction efforts initiated in 2024 and maintained in 2025, in order to align its cost structure with available resources and focus its investments on priority development programs.

Purchases consumed fell by 52% to €1.08 million, from €2.24 million in the first half of 2025. This change is primarily the result of the Company’s ongoing cost-saving program and the gradual ramp-up of the LARKIN program during the half-year.

Personnel costs also decreased by 42%, from €1.51 million to €0.87 million, reflecting the full-year impact of the workforce reduction measures implemented in early 2025.

In addition, the Company’s move to new offices, which took place in early July 2026, is expected to generate additional recurring savings of more than €300,000 per year in operating expenses. However, a provision for risks and charges of €0.16 million was recorded for this half-year to reflect the impact of the move.

Oncodesign Precision Medicine – R&D Expenditure

In €m
Analytical data

H1 2026

H1 2025

Change

in %

in value

Partnerships

0.2

0.5

-54

%

– 0.3

Proprietary

0.7

1.3

-47

%

– 0.6

Total R&D expenses

0.9

1.7

-49

%

– 0.9

Research and development expenditure totaled €0.9 million in the first half of 2026, compared with €1.7 million in the same period of the previous fiscal year, representing a 49% decrease. The Company prioritized the development of its strategic programs, primarily OPM-201 under the LARKIN program, while limiting external expenditure on other programs.

Operating result up 32%, excluding the non-recurring effect in 2025

Operating result came in at -€2.17 million, compared with a profit of €9.79 million in the first half of 2025. As a reminder, the first-half 2025 result included exceptional income of €13 million related to the reinstatement, without financial consideration, of the OPM-201 active ingredient inventory previously held by Servier.

Excluding this non-recurring item, operating result for the first half of 2025 came in at -€3.21 million. Operating income for the first half of 2026 thus showed a 32% improvement on a comparable basis, reflecting the effects of the cost-reduction measures implemented by OPM.

Net financial result came at -€0.16 million, compared with -€0.26 million in the first half of 2025, benefiting from lower financial expenses and an increased financial income generated by available cash.

The Research Tax Credit (CIR) recognized during the period amounted to €0.28 million.

Net result for the first half of the year was therefore a loss of €2.04 million, compared with a profit of €9.85 million in the first half of 2025. Excluding the non-recurring impact of the consolidation of OPM-201 inventory in 2025, it represents a 35% improvement compared with the first half of the previous fiscal year.

Major funding secured from the Michael J. Fox Foundation for the development of OPM-201

In March 2026, OPM received a grant from the Michael J. Fox Foundation for Parkinson’s Research (MJFF), as part of its Therapeutic Pipeline Program (TPP) to support the development of the LARKIN program.

This funding is intended to support the preparation of OPM-201, an LRRK2 kinase inhibitor, with a view to launching a Phase 1b clinical trial in 2027 in patients with early-stage Parkinson’s disease, particularly those carrying an LRRK2 gene mutation.

During the first half of 2026, OPM achieved several important pharmaceuticals, non-clinical, and regulatory development milestones, including the selection of an industrial partner to manufacture tablets for the upcoming clinical phases, the transfer of analytical methods, the micronization of the active ingredient, and the production of an initial feasibility batch. The Company also received favorable feedback from the European Medicines Agency (EMA) on its long-term toxicology study strategy.

An initial payment was received in the first quarter of 2026, helping to fund the next stages of the program’s development.

Cash position of €2.86 million as of June 30, 2026

As of June 30, 2026, OPM had a cash position of €2.86 million, compared with €2.11 million as of December 31, 2025. This cash position notably includes the first payment of the funding granted by the Michael J. Fox Foundation under the LARKIN program.

The Company continues to implement a rigorous cost control policy to preserve its financial resources and focus its efforts on the development of its priority assets.

In parallel, OPM is actively pursuing discussions with several potential partners, particularly regarding OPM-101, OPM-201 and its technology platforms, with a view to securing the funding required to continue its operations.

OPM also retains the option to draw down financing tranches through bonds redeemable in shares (ORA) under its agreement with IRIS, while maintaining a measured approach to their use in order to limit their impact on the Company’s share price.

However, the Company’s ability to continue its operations remains dependent on securing additional financial resources. In this context, there is a material uncertainty that may cast significant doubt on the Company’s ability to continue as a going concern. Based on the factors considered by Management, the Board of Directors has adopted the going concern basis of accounting. Detailed information on this situation will be provided in the notes to the interim financial statements, included in the 2026 half-year financial report, which will be published within the regulatory deadlines.

2026 outlook

OPM-101: continued preparation of the REVERT trial and search for partnerships

Following the approval, in late 2025, of the protocol for the REVERT Phase 1b/2a clinical trial by Swiss regulatory and ethics authorities, OPM continued, in the first half of 2026, the preparatory work necessary for its implementation.

The trial aims to assess the safety and efficacy of OPM-101 in combination with pembrolizumab in patients with advanced melanoma. Efforts have focused on producing the capsules required for the study and finalizing contracts with clinical centers.

At the same time, OPM continues discussions with potential pharmaceutical partners regarding the development of OPM-101 for chronic inflammatory bowel diseases, an indication in which the Company believes the molecule also has therapeutic potential.

OPM-201: preparation of the next clinical steps in Parkinson’s disease

With financial support from the Michael J. Fox Foundation, OPM intends to continue developing the LARKIN program with a view to a Phase 1b clinical trial in 2027.

The next steps will focus mainly on preparing the long-term toxicology study, manufacturing therapeutic units for clinical trials and finalizing the protocol for the next study.

Availability of the 2026 half-year Financial Report

The 2026 half-year financial report will be available on the Company’s website, in accordance with legal requirements, before October 31, 2026.

(Press release, Oncodesign Precision Medicine, OCT 22, 2026, View Source [SID1234673687])

On October 22, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) an innovation-driven, global biopharma company, reported that it has entered into a securities purchase agreement for the sale of 11,340,000 American Depositary Shares ("ADSs"), each representing ten ordinary shares of the Company, to certain investors in a private investment in public equity ("PIPE") financing. The purchase price of each ADS is $22.04. Gross proceeds from the PIPE financing are expected to be approximately $250 million, before deducting placement agent fees and other offering expenses. The PIPE financing is expected to close on or about October 27, 2026, subject to customary closing conditions.

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The financing is led by TCGX and includes participation from other new and existing investors including abrdn World Healthcare Fund, ADAR1 Capital Management, Balyasny Asset Management, Cormorant Asset Management, Frazier Life Sciences, RA Capital Management, RTW Investments, Sirenia Capital Management LP, Wellington Management, and Woodline Partners LP.

Zai Lab intends to use the net proceeds from the PIPE financing primarily to support the continued global development of zocilurtatug pelitecan (zoci), the Company’s Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC).

Leerink Partners is acting as exclusive placement agent for the PIPE financing. Ropes & Gray is acting as legal advisor to Zai Lab.

The sale and issuance of the foregoing ADSs are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"). The ADSs being issued in the PIPE may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the ADSs acquired by the investors in the Private Placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Zai Laboratory, OCT 22, 2026, View Source [SID1234673686])

On October 22, 2026 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing innovative immunotherapies for cancer and immune-mediated diseases, and Aston Sci, Inc., a clinical-stage biotechnology company advancing next-generation immunotherapies, reported a strategic research collaboration to evaluate novel combination therapies joining HanchorBio’s HCB101 macrophage-directed immunotherapy with Aston Sci’s therapeutic cancer vaccine candidates.

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Established under a Memorandum of Understanding (MOU), the collaboration will initially evaluate HCB101 alongside Aston Sci’s lead candidate, AST-301, a HER2-directed plasmid DNA therapeutic vaccine currently in Phase 2 clinical trials. The companies will also explore combinations involving an investigational PD-L1 therapeutic vaccine, extending the collaboration across distinct vaccine modalities and immune mechanisms.

This strategic partnership advances HanchorBio’s strategy to integrate vaccine-directed immune education with macrophage-mediated immune activation, expanding market opportunities, potential clinical indications, and co-development partnerships for both organizations.

Bridging Vaccine-Directed Immune Education with Durable Macrophage Enhancement

Therapeutic cancer vaccines are experiencing renewed momentum across the biopharmaceutical sector, underscored by recent landmark Phase 3 readouts in mRNA neoantigen therapies. However, translating antigen-specific T-cell responses into durable, long-term clinical benefits remains a core challenge because immunosuppressive tumor microenvironments (TMEs) and immune evasion limit their persistence.

HanchorBio and Aston Sci aim to address these challenges by coordinating two arms of the immune system: pairing vaccine-driven adaptive T-cell priming with macrophage-driven innate tumor clearance, followed by antigen presentation that de novo activates additional tumor-reactive T-cell clones.

HCB101 is an engineered SIRPα–IgG4 Fc fusion protein developed through HanchorBio’s proprietary FBDB platform. Designed to block the CD47–SIRPα "don’t eat me" signal, HCB101 reactivates macrophage phagocytosis while minimizing red blood cell toxicity.

By combining HCB101 with Aston Sci’s therapeutic cancer vaccines, the companies intend to create a continuous, self-reinforcing immune loop:
Educate: Therapeutic vaccines generate robust, antigen-specific adaptive T-cell responses.
Execute: HCB101 unblocks tumor-associated macrophages to clear targeted cancer cells.
Amplify: Enhanced phagocytosis releases endogenous tumor neoantigens into the TME.
Re-Engage (Antigen Spreading): Broadened antigen presentation primes new T-cell clones, preventing immune escape and driving durable tumor suppression.

"Cancer vaccines are entering a new era, but teaching the immune system to recognize cancer is only part of the challenge," said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. "We believe the next major breakthrough lies in connecting immune education with immune execution. By pairing HCB101 with Aston Sci’s vaccine platform, we aim to expand the utility of both pipelines and pioneer combination regimens that transcend traditional single-pathway therapies."

Complementary Pipelines and Clinical Strategy

The initial translational research will combine HCB101 with AST-301, Aston Sci’s HER2-directed DNA vaccine currently in Phase 2 clinical development for breast and gastric cancers. Notably, both AST-301 and HCB101 have received U.S. FDA Orphan Drug Designation (ODD) for gastric cancer, establishing a validated regulatory foundation for future joint clinical development.

Preclinical and translational evaluations will measure antitumor efficacy, macrophage reactivation, T-cell kinetics, and epitope spreading beyond HER2. Follow-on studies will explore Aston Sci’s investigational PD-L1 cancer vaccine.

"Therapeutic cancer vaccines hold immense clinical promise, but unlocking their full potential requires pairing them with synergistic immune mechanisms," said Wonil Kim, PhD, CSO of Aston Sci. Inc. "Partnering with HanchorBio allows us to evaluate how HCB101’s macrophage checkpoint blockade complements AST-301’s T-cell activation, opening an emerging immunotherapy for patients with hard-to-treat solid tumors."

Path to Commercial and Strategic Value Creation

The joint strategy emphasizes rapid mechanistic validation to support future clinical co-development. Target indications include HER2-expressing gastric, gastroesophageal junction (GEJ), breast, and colorectal cancers, with a strategic focus on consolidation or maintenance settings to achieve chemotherapy-sparing, long-term tumor control.

"The right tumor biology, clinical setting, and combination strategy are critical to maximizing vaccine performance," said Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) and CEO (USA) of HanchorBio. "Our goal is to demonstrate that pairing immune priming with macrophage engagement leads to deeper, more durable responses. Success here could transform treatment paradigms across multiple solid tumor settings."

Global Partnering at BIO-Europe 2026

Executive leadership from both HanchorBio and Aston Sci will attend BIO-Europe 2026 in Cologne, Germany (November 9–11, 2026) to present the scientific rationale behind the combination and to engage with potential global pharmaceutical partners and investors on next-generation immunotherapy and future strategic collaboration opportunities.

About HCB101

HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB platform. By blocking CD47–SIRPα signaling, HCB101 is designed to enhance macrophage-mediated antitumor immunity. It is currently being evaluated in ongoing Phase 1 monotherapy (NCT05892718) and Phase 1b/2a combination (NCT06771622) clinical studies and has received U.S. FDA Orphan Drug Designation for gastric cancer.

(Press release, Hanchor Bio, OCT 22, 2026, View Source [SID1234673685])

On October 22, 2026 Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, reported that clinical data from a Phase 2 study of BAT8008, a TROP2-targeted antibody-drug conjugate (ADC), in combination with BAT1308, an anti-PD-1 monoclonal antibody in First Line NSCLC, will be presented at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

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The presentation will highlight findings from the combination regimen in patients with first-line non-small cell lung cancer (NSCLC), including an evaluation of its antitumor activity and safety profile. The study reflects Bio-Thera’s continued commitment to advancing innovative antibody-based therapies for patients with significant unmet medical needs.

Lung cancer remains a leading cause of cancer-related mortality worldwide, and NSCLC accounts for the majority of lung cancer cases. Despite advances in immunotherapy and combination treatment approaches, new therapeutic strategies remain an important area of research for patients with advanced NSCLC.

BAT8008 is a TROP2-targeted ADC designed to deliver an exatecan payload, a cytotoxic TOP1 inhibitor, to tumor cells expressing TROP2. BAT1308 is a monoclonal antibody targeting programmed cell death protein 1 (PD-1), an immune checkpoint involved in regulating antitumor immune responses. The combination is being investigated for its potential to integrate targeted cytotoxic activity with immune checkpoint inhibition.

Presentation Details

Congress: 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress
Presentation: First-line BAT8008 (TROP2-ADC) plus BAT1308 (anti-PD-1) for advanced NSCLC: Results from a multicenter Phase 2 study
Presentation format: Rapid Oral 1: NSCLC, metastatic
Abstract number: 2631RO
Date: Saturday, October 24, 2026
Time: 8:30–10:00 a.m. CEST (session window)
Location: Almeria Auditorium, Hall 9
The presentation will provide further insight into the clinical development of this investigational combination. The full data will be presented at the ESMO (Free ESMO Whitepaper) 2026 Congress.

(Press release, BioThera Solutions, OCT 22, 2026, View Source [SID1234673684])