HUTCHMED Reports 2026 Interim Results

On July 30, 2026 HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:HCM; HKEX:13) reported its financial results for the six months ended June 30, 2026 and provides updates on key clinical and commercial developments.

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All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 36.

Global sales growth driven by China rebound and FRUZAQLA geographical expansion

● In-market sales from key China commercial products up over 40% compared to the first half of 2025. ELUNATE (fruquintinib in China) up 41% to $60.8 million as it expanded reimbursement coverage for endometrial cancer and was approved for kidney cancer. SULANDA up 45% to $18.4 million, boosted by upgraded recommendation in Chinese Society of Clinical Oncology guidelines for neuroendocrine tumors.
● In-market sales of FRUZAQLA (fruquintinib ex-China) ex-US up ~70% to $68.9 million during first half of 2026, alongside steady US sales, driven by the need for novel non-chemo treatment options in mCRC and ongoing positive experiences of oncologists in third line setting.
● Profitability maintained amid higher R&D investment, with net income attributable to HUTCHMED at $15.9 million (H1-25: $455.0m including $416.3m gain on divestment of 45% of Shanghai Hutchison Pharmaceuticals Limited (SHPL)), which allowed the Company to maintain a strong cash balance of $1.37 billion.
Multiple first-in-class Antibody-Targeted Therapy Conjugate (ATTC) candidates in clinical trials

● Initiated clinical trial of HMPL-A251 (PI3K/PIKK-HER2) in December 2025 and of HMPL-A580 (PI3K/PIKK-EGFR) in March 2026 and presented preclinical data at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Both ATTCs are progressing through dose escalation as planned.
● HMPL-A830 clinical trial application approved in July 2026, based on a different ATTC payload platform.
Regulatory and clinical achievements across late-stage clinical portfolio

● New Drug Application (NDA) approval of ELUNATE with sintilimab for second-line kidney cancer in China in May 2026, supported by FRUSICA-2 Phase III data showing median progression-free survival (PFS) of 22.2 months vs. 6.9 months in control group.
● NDA acceptance of sovleplenib for warm autoimmune hemolytic anemia (wAIHA) in China in April 2026, supported by ESLIM-02 Phase III data presented at European Hematology Association (EHA) (Free EHA Whitepaper) Congress with durable response rate of 66.0%, along with NDA acceptance for immune thrombocytopenia (ITP) in China in February 2026; both wAIHA and ITP indications received priority review status.

● Positive SACHI Phase III data of ORPATHYS in combination with TAGRISSO (osimertinib) sub-group analysis published in The Lancet in January 2026 with median overall survival (OS) of 22.9 months vs. 7.9 months with chemotherapy. NDA approval for third-line MET-amplified gastric cancer in China in June 2026, supported by Phase II data presented at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting with objective response rate of 32.3%.
● Positive pivotal Phase II data of fanregratinib (FGFR inhibitor) in intrahepatic cholangiocarcinoma presented at European Society for Medical Oncology Gastrointestinal Cancers Congress.
● Initiated Phase III trial of HMPL-760 (BTK inhibitor) in combination with rituximab and chemotherapy for second-line diffuse large B-cell lymphoma in March 2026.
HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English on Thursday, July 30, 2026, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, July 31, 2026. After registration, investors may access the live webcast at www.hutch-med.com/event.

Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, "HUTCHMED has a clear strategic focus: to build a globally competitive oncology portfolio anchored by differentiated innovation. This future is shaped by our global first-in-class Antibody-Targeted Therapy Conjugate (ATTC) novel payload platforms and other emerging large-molecule modalities. These give us multiple opportunities to pursue first-in-class or best-in-class assets, with potential to be used in combination with standard-of-care or newer medicines, in turn conferring front-line treatment prospects. As these programs advance, multinational partnerships – some presently under discussion – can provide important external validation, broaden development reach and accelerate access to major international markets. We will continue to invest in our world-class R&D organization and deploy our resources in areas where HUTCHMED can create significant impact on the lives of patients globally, harnessing the most advanced scientific modalities, while creating commercial and shareholder value."

Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said, "Strong in-market sales growth from ELUNATE and SULANDA in the first half reflects the impact of last year’s streamlining of our salesforce, enhancing productivity with more focused marketing strategies, as we structured our commercial organization to meet the changing China market regulatory guidelines for a sustainable future. We are accelerating ATTC development and strengthening discovery operations through expanding talent and AI capabilities. We are also pursuing business development discussions with multinational partners to expedite global development and commercialization of our most promising programs."

Dr Weiguo Su, Chief Executive Officer (currently on leave of absence) and Chief Scientific Officer of HUTCHMED, said, "The acceptance by the NMPA of the NDA filings for sovleplenib in ITP and wAIHA during the first half of 2026 reflects the strength of the clinical data package, supporting its potential for regulatory and commercial success. Sovleplenib once again attests to the importance of target selectivity, differentiating efficacy and toxicity profiles of our assets. Our ATTC drug candidates are guided by the same principles, designed to navigate our proprietary potent small-molecule targeted therapy payloads to tumor cells while sparing healthy tissues and decreasing side-effects. Pre-clinical data has shown encouraging tumor shrinkage as compared to standard-of-care treatments and emerging therapies recently launched or in development. With three highly novel molecules from two ATTC payload platforms progressing through or about to start first-in-human clinical development, and additional candidates advancing behind them, we are building a science-driven pipeline designed to translate differentiated biology into meaningful clinical benefit."

2026 Interim Results & Business Updates

I. COMMERCIAL OPERATIONS

There was a strong rebound in China in-market sales, achieving $94.4 million in H1 2026, up 32% vs H1 2025 ($71.6 million) as our sales team continues to improve productivity. This contributed to total in-market sales for oncology products of $279.8 million in H1 2026 (H1-25: $234.4 million).

ELUNATE in-market sales were up 41% to $60.8 million, successfully expanded NRDL coverage to include 2L EMC with pMMR in combination with sintilimab. It also renewed coverage in metastatic CRC for patients who have been previously treated with chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF or anti-EGFR (RAS wild-type).

SULANDA in-market sales were up 45% to $18.4 million, driven by an update to Chinese Society of Clinical Oncology guidelines upgrading the usage for SULANDA in neuroendocrine tumors to the highest Level I recommendation standard over competing SSA products. It also benefited from shifting marketing strategies to focus on key hospitals.

FRUZAQLA in-market sales growth was primarily driven by sales outside the US, which had growth of ~70%, contributed by approvals or launches in 41 countries to date, including securing reimbursement in France in Q1 2026 and late 2025 launches in Portugal, Belgium, South Korea and Mexico. This helped boost global in-market sales to $185.4 million.

Total consolidated revenue for oncology products increased 23% to $121.4 million as compared to H1 2025, primarily due to strong in-market sales growth in ELUNATE and SULANDA.

Other Oncology/Immunology revenue, consisting of upfront, regulatory milestones, R&D services and licensing revenue was $40.9 million, including an $18.1 million milestone payment from Eli Lilly, triggered by China approval for 2L RCC. Other Ventures revenue, mainly from prescription drug distribution was $116.0 million, leading to total consolidated revenue of $278.3 million.

($ in millions)

​ ​ ​

In-market Sales*

​ ​ ​

Consolidated Revenue**

​ ​ ​

H1 2026

​ ​ ​

H1 2025

​ ​ ​

%Change (CER)

​ ​ ​

H1 2026

​ ​ ​

H1 2025

​ ​ ​

%Change (CER)

FRUZAQLA

$

185.4

$

162.8

+14%(+14%)

$

43.1

$

43.1

— —

ELUNATE

$

60.8

$

43.0

+41%(+33%)

$

47.1

$

33.6

+40%(+32%)

SULANDA

$

18.4

$

12.7

+45%(+37%)

$

18.4

$

12.7

+45%(+37%)

ORPATHYS

$

15.7

$

15.2

+3%(-3%)

$

13.3

$

9.0

+48%(+39%)

TAZVERIK***

$

(0.5)

$

0.7

— —

$

(0.5)

$

0.7

— —

Oncology Products

$

279.8

$

234.4

+19%(+17%)

$

121.4

$

99.1

+23%(+18%)

Takeda upfront, regulatory milestones and R&D services

$

20.7

$

29.5

-30%(-30%)

Other revenue (R&D services and licensing)

$

20.2

$

14.9

+35%(+35%)

Total Oncology/Immunology

$

162.3

$

143.5

+13%(+10%)

Other Ventures

$

116.0

$

134.2

-14%(-19%)

Total Revenue

$

278.3

$

277.7

— (-4%)

* FRUZAQLA, ELUNATE and ORPATHYS mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively.

** FRUZAQLA represents manufacturing revenue and royalties paid by Takeda to HUTCHMED; ELUNATE represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Eli Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS represents manufacturing revenue and royalties paid by AstraZeneca to HUTCHMED and sales to other third parties invoiced by HUTCHMED; SULANDA and TAZVERIK represent HUTCHMED’s sales of the products to third parties.

*** Ipsen is the Marketing Authorization Holder for TAZVERIK, for which HUTCHMED acts as domestic agent/licensee. In March 2026 Ipsen voluntarily withdrew TAZVERIK from all Ipsen markets, effective immediately, following emerging safety data from the ongoing SYMPHONY‑1 trial.

II. 2026 REGULATORY UPDATES

● Savolitinib sNDA approved by NMPA in 3L MET-amplified GC in June 2026.
● Savolitinib MAA approved (temporary authorization) by Swissmedic in combination with TAGRISSO for 2L EGFRm NSCLC with MET amplification and/or overexpression in February 2026.
● Fruquintinib sNDA approved by NMPA in combination with sintilimab for 2L RCC in May 2026.
● Sovleplenib NDA accepted by NMPA for 2L wAIHA in April 2026.
● Sovleplenib NDA resubmission accepted by NMPA for 2L ITP in February 2026.
● Tazemetostat voluntary withdrawal by Ipsen in China in March 2026.
III. 2026 LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES

Savolitinib (ORPATHYS in China), a highly selective oral inhibitor of MET

● Expecting topline results in H2 2026 for SAFFRON and SANOVO, following full enrollment in H2 2025:
◾ SAFFRON global Phase III study for 2L/3L EGFRm NSCLC patients with MET amplification and/or overexpression could support global filings (NCT05261399).
◾ SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression could support China filing (NCT05009836).
● Published sub-group analysis of SACHI China Phase III study for 2L EGFRm NSCLC patients with MET amplification in The Lancet in January 2026, showing mOS of 22.9 months vs 7.9 months with chemotherapy (HR 0.32) when excluding control group patients who received subsequent MET inhibitor.
● Presented and published positive China Phase II pivotal study data in 3L MET-amplified GC at ASCO (Free ASCO Whitepaper) 2026 and in Nature Medicine in June 2026, respectively, with IRC-assessed ORR of 32.3%, mPFS of 4.0 months and mOS of 6.9 months (NCT04923932).
Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk

● Presented positive ESLIM-02 China Phase III study data in 2L wAIHA at EHA (Free EHA Whitepaper) 2026 Congress in June 2026, having met its primary endpoint of durable response rate of 66.0%, showing median time to response of 3.1 weeks and median cumulative duration of response of 16.1 weeks.
Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3

● Presented positive China Phase II pivotal study data in 2L FGFR2 fusion/rearrangement ICC at ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress in July 2026, having met its primary endpoint of IRC-assessed ORR of 42.5%, as well as showing mPFS of 6.9 months and mOS of 16.6 months. An NDA for 2L ICC was accepted by NMPA with priority review status in December 2025 (NCT04353375).

HMPL-760, a non-covalent, third generation BTK inhibitor, targeting wild-type and C481S-mutated BTK

● Initiated China Phase III study in combination with R-GemOx (rituximab, gemcitabine and oxaliplatin) in patients with 2L relapsed/refractory DLBCL versus placebo in combination with R-GemOx in March 2026 (NCT07409428). Primary endpoints are investigator-assessed PFS and OS.
IV. ANTIBODY-DRUG CONJUGATES RESEARCH & DEVELOPMENT

HMPL-A251, a first-in-class PI3K/PIKK-HER2 ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker

● Progressing a dose-escalation and expansion trial for unresectable, advanced or metastatic HER2-expressing solid tumors with first patient dosed in December 2025 (NCT07228247).
● Preclinical data showed anti-tumor activity in DXd-resistant cell line and good efficacy and safety when in combination with chemotherapy via a differentiated mechanism of action.
HMPL-A580, a first-in-class PI3K/PIKK-EGFR ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to an anti-EGFR IgG1 antibody, via a cleavable linker

● Progressing a dose-escalation and expansion trial for solid tumors, including NSCLC, CRC, HNSCC and ESCC with first patient dosed in March 2026 (NCT07396584).
● Preclinical data presented at AACR (Free AACR Whitepaper) 2026 showing tumor shrinkage in osimertinib-resistant EGFRm NSCLC cell line and good efficacy and safety when used in combination with osimertinib in EGFRm PAM non-altered NSCLC cell line.
HMPL-A830 China/US INDs cleared

● Plans for global clinical trial initiation in H2 2026. Preclinical data showed superior potency and safety profiles to antibodies or small molecules with the same target, with data to be presented at a scientific conference.

V. COLLABORATION UPDATES

ImageneBio is developing IMG-007, a non-T cell depleting, antibody-dependent cell-mediated cytotoxicity-silenced OX40 antagonist discovered by HUTCHMED

● Phase IIb trial (NCT07037901) in patients with moderate-to-severe atopic dermatitis progressing, with an amended protocol and topline data anticipated in the fourth quarter of 2027.
● Phase II trial initiation in patients with alopecia areata expected in 2026, with initial data expected in 2028.
VI. OTHER VENTURES

● Other Ventures consolidated revenue decreased to $116.0 million for the six months ended June 30, 2026 (H1-25: $134.2 million) which has minimal impact on profitability as the segment is predominantly low-margin prescription drug distribution business in China and HUTCHMED continues to optimize working capital management.
● Consolidated net income attributable to HUTCHMED from Other Ventures decreased to $3.8 million (H1-25: $24.0m), primarily due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025.
VII. SUSTAINABILITY

The 2025 Sustainability Report was published in April 2026 alongside the 2025 Annual Report. We have initiated a new target-setting cycle. A list of potential focus initiatives has been identified under our five sustainability pillars: Innovation, Climate Action, Human Capital, Access to Healthcare, and Ethics and Transparency. In 2026, we will develop this into a final list, including a roadmap for achievement and monitoring.

In 2026, our sustainability initiatives have continued to receive strong recognition. Most recently, our commitment was reflected in an upgraded AA rating by MSCI, recognizing HUTCHMED as a Leader, and placing us among the top 19% of pharmaceutical companies. For its second consecutive year, HUTCHMED was recognized as Most Honored Company and ranked 1st place in ESG in its sector by Extel, formerly Institutional Investor Research, in its 16th Asia Executive Team Survey. It achieved top rankings across several areas – leading CEO, CFO, Investor Relations, ESG and Corporate Governance – earning the Most Honored Company designation. HUTCHMED was the only company to earn these designations in 2026 in All Asia (ex-Mainland China) Biopharmaceuticals.

Financial Highlights

Revenue for the six months ended June 30, 2026 was $278.3 million compared to $277.7 million for the six months ended June 30, 2025.

● Oncology/Immunology consolidated revenue amounted to $162.3 million (H1-25: $143.5m):
◾ ELUNATE revenue was $47.1 million, up 40% (H1-25: $33.6m), comprising manufacturing revenue, promotion and marketing services revenue and royalties, supported by ongoing label expansions.
◾ SULANDA revenue was $18.4 million, up 45% (H1-25: $12.7m), driven by marketing strategies focusing on key hospitals and supported by recent oncology clinical guideline upgrades.
◾ ORPATHYS revenue was $13.3 million, up 48% (H1-25: $9.0m), driven by higher manufacturing sales to AstraZeneca in preparation for the 3L MET-amplified GC launch.
◾ FRUZAQLA revenue was $43.1 million (H1-25: $43.1m), reflecting continued growth in royalties, offset by reduced manufacturing revenue compared to the prior period, driven by strong in-market sales growth following approvals/launches in 41 countries to date.
◾ Takeda upfront, regulatory milestones and R&D services revenue were $20.7 million (H1-25: $29.5m), due to less R&D and regulatory support services to Takeda.
◾ Other revenue of $20.2 million (H1-25: $14.9m), includes an $18.1 million milestone payment from Eli Lilly triggered by China approval of ELUNATE in combination with sintilimab for 2L RCC (H1-25: $11.1 million regulatory milestone from AstraZeneca following China NDA approval for SACHI).
● Other Ventures consolidated revenue of $116.0 million (H1-25: $134.2m), primarily due to scaling down low-margin logistics distribution sales after considering working capital.
Net Expenses for the six months ended June 30, 2026 were $262.4 million compared to $239.0 million for the six months ended June 30, 2025.

● Cost of Revenue was $152.2 million (H1-25: $167.6m), predominantly due to a lower cost of sales related to the prescription drug distribution business. Cost of revenue as a percentage of oncology product revenue improved to 33% (H1-25: 39%) driven by enhanced productivity and efficiency.
● R&D Expenses were $78.8 million (H1-25: $72.0m) as we initiated early-stage global clinical programs for our ATTC assets and we maintain ongoing investment in discovery to deliver sustained innovation.
● S&A Expenses were $46.5 million (H1-25: $41.6m), driven by strong performance of our Oncology/Immunology commercial operations and enhanced productivity.
● Other Items generated net income of $15.1 million (H1-25: $42.2m), which mainly includes interest income and expense, foreign exchange, equity in earnings of SHPL and taxes. The decrease was mainly due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025.

Net Income attributable to HUTCHMED for the six months ended June 30, 2026 was $15.9 million compared to $455.0 million for the six months ended June 30, 2025.

● $0.02 basic earnings per ordinary share / $0.09 basic earnings per ADS in the first half of 2026 (H1-25: $0.53 basic earnings per ordinary share / $2.65 basic earnings per ADS).
Cash, Cash Equivalents and Short-Term Investments were $1,374.8 million as of June 30, 2026 compared to $1,367.3 million as of December 31, 2025.

● Adjusted Group (non-GAAP) net cash inflow excluding financing activities in the first half of 2026 was $10.5 million mainly due to net income of $16.2 million less $5.6 million in capital expenditures (H1-25: net cash inflow of $519.1m mainly due to the $549.0m net proceeds from the partial divestment of SHPL less a $10.0m regulatory approval milestone payment and $9.2m in capital expenditures).
● Net cash used in financing activities in the first half of 2026 totaled $2.9 million mainly due to net repayments of bank borrowings (H1-25: net cash inflow of $9.3m mainly due to proceeds from bank borrowings of $8.2m).
Foreign exchange impact: The RMB appreciated against the US dollar on average by approximately 5% during the first half of 2026, which has impacted consolidated financial results as highlighted.

Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

FINANCIAL GUIDANCE

HUTCHMED reiterates full year 2026 guidance for Oncology/Immunology consolidated revenue in the range of $330 million to $450 million. HUTCHMED will leverage its strong cash resources to accelerate ATTC global development and explore investment opportunities. Shareholders and investors should note that:

● The Company does not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; and
● The Company has in the past revised its financial guidance and reference should be made to announcements it publishes regarding any updates to the financial guidance after the publication of this announcement.

Financial Summary

Condensed Consolidated Balance Sheets Data

(in $’000)

​ ​ ​

As of

​ ​ ​

As of

June 30, 2026

December 31, 2025

Assets

(Unaudited)

Cash and cash equivalents and short-term investments

1,374,817

1,367,275

Accounts receivable

117,556

126,750

Other current assets

61,036

73,317

Property, plant and equipment

93,788

94,623

Investment in equity investees

11,020

10,865

Other non-current assets

78,210

80,267

Total assets

1,736,427

1,753,097

Liabilities and shareholders’ equity

Accounts payable

33,646

45,533

Other payables and accruals

197,627

208,892

Bank borrowings

94,508

93,160

Deferred revenue

27,630

51,547

Other liabilities

108,048

102,703

Total liabilities

461,459

501,835

Company’s shareholders’ equity

1,260,776

1,237,926

Non-controlling interests

14,192

13,336

Total liabilities and shareholders’ equity

1,736,427

1,753,097

Condensed Consolidated Statements of Operations Data

(Unaudited, in $’000, except share and per share data)

​ ​ ​

Six months ended June 30,

​ ​ ​

2026

​ ​ ​

2025

Revenue:

Oncology/Immunology – Marketed Products

121,434

99,039

Oncology/Immunology – R&D

40,887

44,408

Oncology/Immunology Consolidated Revenue

162,321

143,447

Other Ventures

115,966

134,230

Total revenue

278,287

277,677

Operating expenses:

Cost of revenue

(152,158)

(167,577)

Research and development expenses

(78,783)

(71,990)

Selling and administrative expenses

(46,477)

(41,624)

Total operating expenses

(277,418)

(281,191)

Gain on divestment of an equity investee

477,456

Other income, net

12,784

21,650

Income before income taxes and equity in earnings of equity investees

13,653

495,592

Income tax expense

(1,209)

(2,029)

Income tax expense – Divestment of an equity investee

(61,133)

Equity in earnings of equity investees, net of tax

3,798

23,125

Net income

16,242

455,555

Less: Net income attributable to non-controlling interests

(314)

(601)

Net income attributable to HUTCHMED

15,928

454,954

Earnings per share attributable to HUTCHMED (US$per share)

– basic

0.02

0.53

– diluted

0.02

0.52

Number of shares used in per share calculation

– basic

865,770,498

857,038,725

– diluted

872,869,494

872,564,513

Earnings per ADS attributable to HUTCHMED (US$per ADS)

– basic

0.09

2.65

– diluted

0.09

2.61

Number of ADSs used in per ADS calculation

– basic

173,154,100

171,407,745

– diluted

174,573,899

174,512,903

(Press release, Hutchison China MediTech, JUL 30, 2026, View Source [SID1234669532])

NMPA Accepts New Indication Application for Sacituzumab Tirumotecan (sac-TMT) as First-Line Treatment for Advanced TNBC

On July 30, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that a new indication application of its trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the first-line treatment of patients with recurrent or metastatic triple-negative breast cancer (TNBC) who have a programmed death ligand 1 (PD-L1) combined positive score (CPS) <10, or have recurred after prior programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy in the early stage. This marks the sixth indication application accepted by the NMPA for sac-TMT.

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The acceptance for review is based on the positive results from the randomized, open-label, multicenter Phase III registrational OptiTROP-Breast03 study evaluating the efficacy and safety of sac-TMT versus investigator’s choice of chemotherapy in patients with unresectable recurrent or metastatic TNBC who have not received prior systemic therapy for advanced disease. The enrolled population included patients with PD-L1 CPS <10, as well as those who have recurred after prior PD-1/PD-L1 inhibitor therapy in the early stage. The study demonstrated that sac-TMT achieved statistically significant and clinically meaningful improvements in key efficacy profile compared with investigator’s choice of chemotherapy, showing a clear clinical benefit.

Previously, sac-TMT was granted Breakthrough Therapy Designation (BTD) by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1-negative TNBC. This new indication application has also been included in the priority review and approval process, becoming the sixth application for sac-TMT to enter this process. Inclusion in this process is expected to further expedite the review and approval, allowing this innovative treatment to benefit patients sooner.

Dr. Michael Ge, CEO of Kelun-Biotech, said, "Following the approval of sac-TMT for second-line or later treatment of TNBC based on results from the Phase III OptiTROP-Breast01 study, we are delighted to see another important milestone in the same disease area. For patients with PD-L1-negative advanced TNBC, the efficacy of traditional chemotherapy is limited, and there is an urgent clinical need for more effective and safer first-line treatment options. The positive results from the OptiTROP-Breast03 study demonstrate a clear and clinically meaningful improvement in efficacy with sac-TMT compared to chemotherapy and support the continued evaluation of sac-TMT as the first-line treatment for TNBC. We look forward to the early approval of this indication to bring a new and more effective first‑line treatment option to a broader population with advanced TNBC."

About sac-TMT(佳泰莱)

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 non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, 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 the payload 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 (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) 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); 2) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six BTDs by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. Two new indication applications have been accepted for review by the NMPA and have been included in the priority review and approval process: 1) sac-TMT in combination with pembrolizumab (KEYTRUDA[1]) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 tumor proportion score (TPS)≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative; and 2) sac‑TMT as first‑line treatment for patients with recurrent or metastatic TNBC who have a PD‑L1 CPS <10 or have recurred after prior PD‑1/PD‑L1 inhibitor therapy in the early stage. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, JUL 30, 2026, View Source [SID1234669552])

XPORT-EC-042 Trial Topline Data

On July 30, 2026, Karyopharm Therapeutics Inc. (the "Company") reported topline results from its Phase 3 XPORT-EC-042 trial evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer. The trial did not meet its primary endpoint of progression free survival ("PFS"). In the trial, patients were randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The trial included two patient populations, for which the primary endpoint of PFS was designed to be tested sequentially: (1) a modified intent to treat population ("mITT") that included patients with either (a) TP53 wild-type tumors with proficient mismatch repair status ("pMMR") or (b) TP53 wild-type tumors with deficient mismatch repair status ("dMMR"), who are medically ineligible to receive checkpoint inhibitors; and (2) the trial’s original intent to treat ("ITT") population, which included all patients enrolled in the trial whose tumors are TP53 wild-type, regardless of MMR status.

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A trend favoring the selinexor arm was observed in the mITT population (n=236), with a median PFS of 12.75 months in the selinexor arm compared to 7.43 months in the placebo arm (hazard ratio=0.76 [95% CI: 0.51, 1.12]; one-sided p-value=0.0791).

The safety and tolerability profile of selinexor was consistent with its established safety profile, with no new safety signals observed. The Company intends to complete a full evaluation of the data from the XPORT-EC-042 trial and plans to present the data at a future medical meeting. The results of the XPORT-EC-042 trial do not affect ongoing trials of selinexor in other potential indications.

Myelofibrosis Update

On July 30, 2026, the Company announced that it plans to submit a supplemental New Drug Application ("sNDA") to the U.S. Food and Drug Administration ("FDA") in August 2026 seeking accelerated approval of selinexor in combination with ruxolitinib for the treatment of patients with myelofibrosis.

The planned submission follows productive engagements with the FDA, including written feedback that spleen volume reduction ≥ 35% ("SVR35") appears to qualify as a reasonably likely surrogate endpoint to predict overall survival and can be used to support an sNDA under the accelerated approval pathway. The Company plans to use overall survival data from long-term follow-up of the ongoing Phase 3 SENTRY trial to verify clinical benefit. Overall survival is a pre-specified secondary endpoint of SENTRY. The trial does not permit patient crossover; patients, investigators and the Karyopharm study team remain blinded to treatment assignment during ongoing follow-up.

The planned sNDA will be based on results from the randomized, double-blind, Phase 3 SENTRY trial that compared selinexor in combination with ruxolitinib against placebo in combination with ruxolitinib, including the statistically significant improvement in SVR35 at week 24, the rapid, deep and sustained nature of the spleen responses, a promising overall survival signal, reductions in variant allele frequency and the overall safety data package.

The Company intends to request Priority Review at the time of submission of the sNDA, which, if granted, would result in a Prescription Drug User Fee Act target action date approximately six months following the FDA’s receipt of the application.

The Company is actively engaged with the FDA on the final details of the sNDA submission. Contemporaneously with the Company’s announcement, the Company received additional correspondence from the FDA indicating that the FDA requires further discussion on the data to be used to support the sNDA and convert potential accelerated approval to traditional approval. The Company intends to address the FDA’s requests and provide the FDA with additional data and information prior to the submission of the sNDA in August 2026.

Corporate Update

The Company, with the assistance of its advisors, including its financial advisor Centerview Partners, is exploring potential financing transactions to extend its cash runway along with strategic alternatives in order to maximize both near and long-term value for all stakeholders. The Company’s ability to successfully consummate a financing transaction or execute on a strategic alternative is dependent on a number of factors. There is no assurance that these efforts will result in any type of transaction or, if they do, what the ultimate terms of any such transaction would be. The Company does not intend to discuss or disclose further developments unless and until its Board of Directors has approved a specific transaction or the Company otherwise determines that further disclosure is appropriate.

(Press release, Karyopharm, JUL 30, 2026, View Source [SID1234669574])

Illumina Reports Financial Results for Second Quarter of Fiscal Year 2026

On July 30, 2026 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the second quarter of fiscal year 2026.

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Second quarter 2026 results
•Revenue of $1.16 billion for Q2 2026, up 9.5% from Q2 2025 and up 8.1% excluding the impacts of currency, acquisitions, and China ("ROW1 organic revenue growth")
•GAAP operating margin of 21.1% and non-GAAP operating margin of 22.5%
•GAAP diluted EPS of $1.35 and non-GAAP diluted EPS of $1.31

"Illumina delivered strong results during the second quarter. Momentum continued to build through the first half of 2026, as our technology is enabling clinical customers to expand sequencing-intensive applications. Based on this performance, we are increasing our revenue and earnings guidance for the year," said Jacob Thaysen, Chief Executive Officer of Illumina. "Demand for NovaSeq X remains high as we expand our workflow and multiomics capabilities, broadening the value of Illumina’s ecosystem."

Fiscal year 2026 guidance
For fiscal year 2026, we now expect:
•Total revenue of $4.60-$4.64 billion, versus prior guidance of $4.52-$4.62 billion
•ROW organic revenue growth greater than 5%, versus prior guidance of 2%-4%
•Non-GAAP operating margin of 23.4%-23.6%, unchanged from prior guidance
•Non-GAAP diluted EPS of $5.30-$5.40, versus prior guidance of $5.15-$5.30

Second quarter results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q2 2026 Q2 2025 Q2 2026 Q2 2025
Revenue
$ 1,159 $ 1,059 $ 1,159 $ 1,059
Gross margin
66.4 % 65.6 % 68.2 % 69.4 %
Operating profit
$ 245 $ 214 $ 260 $ 252
Operating margin 21.1 % 20.2 % 22.5 % 23.8 %
Diluted EPS $ 1.35 $ 1.49 $ 1.31 $ 1.19

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.

Capital expenditures for free cash flow purposes were $39 million for Q2 2026. Cash flow provided by operations was $201 million, compared to $234 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $162 million for the quarter, compared to $204 million in the prior year period. Depreciation and amortization expense was $70 million for Q2 2026. At the close of the quarter, the company held $1.17 billion in cash, cash equivalents and short-term investments.

Conference call information
The conference call will begin at 1:30 pm Pacific Time (4:30 pm Eastern Time) on Thursday, July 30, 2026. Interested parties may access the live webcast via the Investor Info section of Illumina’s website or directly through the following link – View Source To ensure timely connection, please join at least ten minutes before the scheduled start of the call. A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

(Press release, Illumina, JUL 30, 2026, View Source [SID1234669533])

Tempus Reports Second Quarter 2026 Results

On July 30, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported financial results for the quarter ended June 30, 2026.

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"Q2 was another exceptional quarter for us," said Eric Lefkofsky, Founder and CEO of Tempus. "Our strategy is working given the investments we have made in AI over the past several years are driving some of the best growth rates we have seen in our two largest businesses – Oncology Diagnostics and Data Licensing."

Second Quarter 2026 Highlights

Total revenue of $382.5 million, up 22% year-over-year
Oncology volume growth of 31% year-over-year, up from 28% last quarter
Molecular residual disease (MRD) volume was 9,000 tests, up from 6,500 last quarter
Data Licensing & Modeling (Insights) revenue up 36% year-over-year
Signed ~$200 million in new Data and Applications licenses
FDA approved xT Tumor Only which will migrate tissue testing to ADLT pricing
Successfully delivered our first oncology foundation model to AstraZeneca
Completed a $460 million offering of 0.0% convertible senior notes due 2032
GAAP net income of $5.6 million and Adjusted EBITDA of $8.0 million
Cash and marketable securities of $820.7 million as of June 30, 2026
Increasing revenue guidance to $1.595 to $1.605 billion for 2026 and expect full year Adjusted EBITDA of ~$65 million
On July 20, 2026, Tempus also announced an agreement to acquire Personalis, a leader in the tumor-informed MRD space. "Through our existing collaboration with Personalis, we have already demonstrated the strength of combining highly sensitive MRD technology with our commercial infrastructure," said Mr. Lefkofsky. "With clinical adoption and reimbursement momentum building, we believe we are collectively well positioned to capture this opportunity, which makes this acquisition particularly exciting."

Second Quarter 2026 Summary Results

Revenue increased 22% year-over-year to $382.5 million.
Diagnostics generated $289.3 million of revenue, representing 20% year-over-year growth, driven by Oncology volume growth of 31%, offset by Hereditary revenue growth of 5%.
Data and Applications generated $93.2 million of revenue, representing 28% year-over-year growth, with Insights growing 36%.
Gross profit increased 26% year-over-year to $246.5 million, led by growth in Data and Applications.
Net income was $5.6 million, which included $55.6 million of stock compensation expense and related employer payroll taxes and $98.5 million in unrealized gains on marketable securities, compared to a net loss of $(42.8 million) in Q2 of 2025.
Adjusted EBITDA was $8.0 million, compared to ($5.6 million) in Q2 of 2025.
$820.7 million in cash and marketable securities as of June 30, 2026.
Recent Operational Highlights

Entered into a definitive agreement to acquire Personalis for $16.25 per share (~$1.5 billion enterprise value), tightly integrating its ultrasensitive NeXT Personal MRD technology into Tempus’ diagnostic platform
Received FDA approval for tumor-only xT CDx assay, becoming the first laboratory to hold FDA companion diagnostic (CDx) approval for both tumor-only and tumor-normal comprehensive genomic profiling
Launched digital pathology IMS Open-Source Consortium along with Yale New Haven Hospital (YNHH) and Memorial Sloan Kettering Cancer Center (MSK) to accelerate the democratization and standardization of digital pathology
Introduced Tempus Preview to provide preliminary results for high impact biomarkers within ~24 hours of tissue receipt
Announced a strategic collaboration with the Keck School of Medicine of USC to integrate Tempus’ AI platform, molecular diagnostics, and clinical trial matching across more than 1.5 million annual patient visits to accelerate precision oncology care
Introduced initial results from and successfully delivered the first version of our foundation model to AstraZeneca
Signed large deals with BioNTech, Daiichi Sankyo, Level Set Bio, and Incyte Pharmaceuticals, contributing to ~$200 million in total bookings this quarter
Second Quarter Financial Results

Three Months Ended June 30,

2026

2025

Change

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

$

382,486

$

314,635

22

%

Gross profit

$

246,498

$

195,039

26

%

Loss from operations

$

(75,913

)

$

(61,774

)

23

%

Non-GAAP loss from operations

$

(2,708

)

$

(17,036

)

(84

)%

Net income (loss)

$

5,642

$

(42,843

)

113

%

Non-GAAP net loss

$

(7,726

)

$

(37,327

)

(79

)%

Adjusted EBITDA

$

8,044

$

(5,580

)

244

%

Net income (loss) per share, basic

$

0.03

$

(0.25

)

112

%

Non-GAAP net loss per share, basic

$

(0.04

)

$

(0.22

)

(82

)%

Financial Outlook and Guidance

Tempus is increasing its full year 2026 revenue guidance to $1.595 to $1.605 billion, which represents ~25% annual growth. We continue to expect 2026 Adjusted EBITDA to be ~$65 million. Guidance assumes no impact from the Personalis transaction, which is expected to close in late Q4 2026 or early 2027.

For additional information on the quarter, including a letter from our CEO and CFO, please visit our investor relations site at investors.tempus.com.

Webcast and Conference Call Information

A conference call and webcast will begin today, July 30, 2026 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 9053038
United States – New York: (646) 307-1963
USA & Canada – Toll-Free: (800) 715-9871
Live webcast can be accessed here

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO, and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

(Press release, Tempus, JUL 30, 2026, View Source [SID1234669553])