On March 25, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the signing of a large-scale Manufacturing Supply Agreement for copper-64 with Theragenics.

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The agreement relates to Theragenics’ 134,000 square foot production facility with a fleet of 14 cyclotrons close to Atlanta, Georgia, a major US transport hub, for centralised, large-scale copper-64 (Cu-64 or 64Cu) production ahead of anticipated 64Cu-SAR-bisPSMA commercial launch upon successful completion of Clarity’s Phase III registrational trials with this product, AMPLIFY1 and CLARIFY2, and subsequent US Food and Drug Administration (FDA) New Drug Application (NDA) approval.

Theragenics have substantial cyclotron expertise with 40 years of routine radiometal production and considerable experience in production of radioisotopes for medical use. Combined with a sizeable fleet of high-current cyclotrons, this constitutes an opportunity for large-scale copper-64 manufacturing at the site. Theragenics have capacity to produce around 100Ci (3.7 TBq) of copper-64 per day on a single cyclotron, which translates into around 2,000 patient doses per day on each cyclotron at 200 MBq per dose with a 48-hour shelf life. Together with Clarity’s existing copper-64 supply agreements with SpectronRx and Nusano, this agreement with Theragenics further enhances Clarity’s broad network of high-volume copper-64 manufacturers in distinct US geographies. The network is designed to support commercial-scale demand across multiple large oncology indications with secure, seamless and abundant supply of this diagnostic isotope, made possible with the 12.7-hour half-life of copper-64, which is unique in the radiopharmaceutical commercial space.

Mark Pugh, CEO of Theragenics, commented, "We are excited to enter into this Manufacturing Supply Agreement for copper-64 with Clarity. Having a current commercial sales force in prostate cancer, we have a deep insight into this field and have seen the excitement from key opinion leaders around 64Cu-SAR-bisPSMA. This agreement continues our expansion into the contract manufacturing organisation (CMO) isotope market, and we see Clarity as an ideal partner to advance this vision. Clarity is in a unique position with two diagnostic Phase III trials nearing completion, three Fast Track Designations (FTDs) from the US FDA and impressive data generated to date. With our core expertise and experience in producing radiometals for commercial medical purposes at Theragenics, together we can expand access to radiopharmaceuticals and bring a next-generation platform to patients in need of better diagnostics in the US."

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "Clarity is closer than ever to commercialisation of 64Cu-SAR-bisPSMA, with outstanding data recently released from the head-to-head Co-PSMA investigator-initiated trial3 and our announcement on achieving our target number of participants in the Phase III AMPLIFY trial just months since imaging the first patient4.

"The growing body of scientific evidence, along with the FTDs from the FDA are providing great momentum for 64Cu-SAR-bisPSMA. Building out a secure, reliable and abundant supply and manufacturing strategy is now coming into play, ensuring a solid base for our commercial launch and accelerated market expansion, subject to FDA approval. Our team is committed to continue working closely with our vendors, clinicians, participating clinical trial sites, regulatory agencies and supply and manufacturing facilities to get 64Cu-SAR-bisPSMA to patients in need as soon as possible, at scale to meet the future demand.

"The longer half-life of copper-64 (12.7 hours vs. less than 2 hours for the radionuclides currently used in prostate-specific membrane antigen [PSMA] positron emission tomography [PET], i.e. gallium-68 and fluorine-18) translates into a shelf-life of up to 48 hours for 64Cu-SAR-bisPSMA. As such, copper-64 offers greater flexibility for supply and scheduling of patients, overcoming various limitations of the short half-life isotopes currently used in radiodiagnostics. This represents a unique opportunity to implement a multi-tiered service approach comprising of large, local, centralised manufacturing with broad geographic distribution. Importantly, we have the opportunity to avoid the excessive costs, waste and inefficiencies associated with the supply and manufacture of short half-life isotopes. Our goal is to take the industry in a new direction of scalability and profitability while delivering universal access to radiodiagnostics for physicians and the patients they serve.

"Theragenics has decades of experience in the commercial production of radiometals for medical purposes and valuable insight into the prostate cancer field based on their existing brachytherapy business. We look forward to working with them as we prepare to take the next steps in our development."

The Manufacturing Supply Agreement is effective as of 25 March 2026. Cancellation and extension provisions are aligned with industry standard rates.

(Press release, Clarity Pharmaceuticals, MAR 25, 2026, View Source [SID1234663861])

On March 25, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Terns Pharmaceuticals, Inc. ("Terns") (Nasdaq: TERN), a clinical-stage oncology company, reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Terns for $53.00 per share in cash for an approximate equity value of $6.7 billion. This equates to approximately $5.7 billion net of acquired cash and represents an approximate premium of 31% to the 60-day and 42% to the 90-day volume-weighted average stock price on March 24, 2026.

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"The acquisition of Terns builds on our growing presence in hematology with TERN-701, a potential best-in-class candidate for the treatment of certain patients with chronic myeloid leukemia," said Robert M. Davis, chairman and chief executive officer, Merck. "This transaction further diversifies and strengthens our position in oncology as we continue to look for opportunities to broaden our portfolio into other therapeutic areas."

Terns’ lead candidate, TERN-701, is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) currently being evaluated in the Phase 1/2 CARDINAL trial (NCT06163430) for patients with Philadelphia chromosome-positive (Ph+), chronic phase chronic myeloid leukemia (CML) previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. In March 2024, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of CML.

"This acquisition reflects our team’s deep commitment to innovation in oncology and developing high impact medicines," said Amy Burroughs, chief executive officer, Terns. "By working together, we will advance TERN-701, leveraging the deep expertise and significant resources at Merck, a global biopharmaceutical leader with a proven track record of delivering cancer breakthroughs for patients who need them most. I am immensely proud of the Terns team and our work towards making a difference for people living with CML. Finally, we extend our heartfelt thanks to the investigators, patients, and community advocates whose dedication and support make the development of TERN-701 possible."

In clinical trials to date, TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response observed by week 24. Importantly, this includes responses in patients with high disease burden who previously received multiple lines of therapy, including many who were treated with an allosteric TKI. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations. No clinically meaningful changes in blood pressure have been observed, and rates of lipase elevation have been low.

"The first approval of a BCR::ABL1 tyrosine kinase inhibitor 25 years ago transformed the prognosis for many patients with chronic myeloid leukemia. Despite new therapeutic options, there is significant need for innovative, well-tolerated therapies with faster time to onset of molecular response leading to deeper responses and better disease control," said Dr. Dean Y. Li, president, Merck Research Laboratories. "Based on early clinical evidence, TERN-701, a novel allosteric BCR::ABL1 inhibitor, may have the potential to provide a meaningfully differentiated option for certain patients living with CML."

The transaction has been approved by both Merck’s and Terns’ Boards of Directors. Under the terms of the merger agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Terns. The acquisition is subject to a majority of Terns’ stockholders tendering their shares in a tender offer that will be initiated by a subsidiary of Merck. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to be accounted for as an asset acquisition and close in the second quarter of 2026, resulting in a charge of approximately $5.8 billion, or approximately $2.35 per share, included in both second quarter and full year 2026 GAAP and non-GAAP results.

A copy of the merger agreement for the transaction will be filed with the Securities and Exchange Commission ("SEC") and will be publicly available free of charge at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge from Merck’s website at www.merck.com or by contacting Merck at 126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ 07065 USA, or (908) 740-4000. Copies of the documents filed with the SEC by Terns may be obtained at no charge from Terns’ website at www.ternspharma.com or by contacting Terns at 1065 East Hillsdale Blvd., Suite 100, Foster City, CA 94404 or (650) 525-5535 Ext.101.

Investor Call
Merck will hold an investor call Wednesday, March 25, 2026 at 8 a.m. EDT to discuss the proposed transaction. Journalists who wish to ask questions should contact a member of Merck’s Global Media Relations team at the conclusion of the call. Investors, journalists and the general public may access a live audio webcast of the call via this weblink.

All participants may join the call by dialing (800) 369-2154 (U.S. and Canada Toll-Free) or (517) 308-9422 and using the access code 8711041.

Advisors
Centerview Partners LLC and Jefferies LLC acted as financial advisors to Terns and Freshfields LLP acted as Terns’ legal advisor.

About TERN-701
TERN-701 is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) designed to bind to the ABL myristoyl pocket, with a potentially best-in-disease profile that could improve upon the efficacy, safety and convenience of existing treatments for CML.

About the CARDINAL study
TERN-701 is currently being evaluated in the CARDINAL trial (NCT06163430), a global multi-center dose escalation and dose-expansion clinical trial to assess safety, tolerability and efficacy in patients with Philadelphia chromosome-positive (Ph+) chronic phase CML previously treated with at least one prior TKI and experienced treatment failure, suboptimal response, or treatment intolerance. The dose escalation portion of the CARDINAL trial completed in January 2025 with no dose limiting toxicities observed up to the maximum dose of 500mg QD. Terns initiated the dose expansion portion of the trial in April 2025 with patients randomized to one of two dose cohorts (320mg or 500mg QD) with up to 40 patients per arm. In January 2026, an additional cohort was added to the CARDINAL trial to evaluate TERN-701 500 mg QD in approximately 20 patients with BCR::ABL1 resistance mutations including T315I, M244V, F359I/C/V and others.

About chronic myeloid leukemia
Chronic myeloid leukemia (CML) is a slow growing type of blood cancer that leads to an overproduction of white blood cells that accumulate in the blood and bone marrow, disrupting the production of healthy blood cells. CML is commonly associated with the Philadelphia chromosome, a translocation between chromosomes 9 and 22 that results in constitutive activation of the BCR::ABL1 fusion protein, which fuels cancer growth.

(Press release, Merck & Co, MAR 25, 2026, View Source [SID1234663904])

On March 25, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported the annual results for 2025 as of December 13, 2025.

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2025 marked InnoCare’s 10th anniversary and a milestone year of transformative growth and strategic execution. The Company achieved its first full year profitability, secured two new drug application (NDA) approvals, enhanced market penetration of its core products, accelerated globalization, and made breakthroughs across multiple pipelines. With numerous "China First" achievements, InnoCare continues to accelerate its 2.0 development strategy, demonstrating its strong ability to translate scientific innovations into sustainable long-term growth.

Financial Highlights

Revenue grew 135.3% year-on-year to RMB 2,375 million1 in 2025, mainly driven by robust commercial growth and two strategic business development (BD) deals.
Profit reached RMB 644 million, achieving profitability for the first time, mainly due to significant commercialization growth and global out-licensing deals.
Gross Profit Margin increased by 5.7 percentage points to 92%.
Research and Development Investment increased by 16.9% to RMB 952 million in 2025, reflecting advancements of multiple Phase III registrational trials, as well as increased investments in new technology platforms such as ADCs and molecular glue.
Cash and Related Accounts Balance2 stood at approximately RMB 7.8 billion as of December 31, 2025 and achieved positive operating cash flow for the first time. This strong cash position provides InnoCare with the flexibility to expedite global clinical development of key assets and invest in new technology platforms.
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1 The financial figures in this article are based on Hong Kong Financial Reporting Standards
2 Include cash and bank balances, other current assets, financial assets among other non-current assets, and interest receivable

Accelerating Globalization with Transformative Deals

In 2025, InnoCare accelerated the implementation of its globalization strategy, unlocking global value of its core pipeline with two out-licensing deals, further enhancing the Company’s global influence and financial performance, and marking a significant step forward in its global expansion.

On Oct. 8, InnoCare entered into a transformative licensing agreement with Zenas for its autoimmune disease pipeline, including orelabrutinib. The agreement includes up to US$100 million in upfront and near-term milestone payments, and up to 7,000,000 shares of Zenas common stock, with a total deal value exceeding US$ 2 billion, setting a new record for small molecule autoimmune out-licensing in China.

This strategic collaboration marks a significant milestone in InnoCare’s globalization journey and will leverage shared focus to accelerate the global Phase III clinical development of orelabrutinib for the treatment of primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS), maximizing its clinical and commercial value worldwide, and advance a novel oral IL-17 AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor into clinical trials.

In addition, InnoCare entered into a licensing agreement with Prolium to further its global presence in 2025. In March 2026, Prolium announced first dosing of healthy volunteers in an ongoing single ascending dose study of ICP-B02 (PRO-203) and expects to initiate a multinational Phase I/II study of ICP-B02 in systemic sclerosis (SSc) in the second quarter of 2026, with additional studies in B-cell-driven autoimmune disease expected to follow.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "Building on an inspiring decade of solid growth, we have continuously enhanced our fully integrated platform ranging from original innovation, clinical development, commercialization, manufacturing, to business development, achieving our strategic goal of break-even ahead of schedule, marking a significant milestone in our development history. As we enter our 2.0 phase of rapid development, we are focused on key strategic priorities, including securing approvals for five to six innovative drugs, advancing three to four products globally, and progressing five to ten differentiated molecules into clinical trials. We will further accelerate globalization, significantly increase revenue, and deliver more high-quality innovative therapies to benefit patients worldwide."

Building A Leading Franchise in Hemato-Oncology

In 2025, InnoCare made significant progress toward building a leading hemato-oncology franchise, driven by advances in commercial execution, late-stage clinical development, and global expansion.

InnoCare continued to strengthen its commercial portfolio with orelabrutinib approved for first line chronic lymphocytic leukemia/small lymphocytic lymphoma (1L CLL/SLL) and successfully included in the updated National Reimbursement Drug List (NRDL), while tafasitamab became the first CD19 antibody approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in China. As a result, drug sales increased by 43.4% to RMB 1,442 million in 2025.

Mesutoclax (ICP-248), the first BCL2 inhibitor granted Breakthrough Therapy Designation in China, continues to advance across multiple indications, including CLL/SLL, mantle cell lymphoma (MCL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), with clinical trials ongoing in China and globally. Together, these three assets form the core of InnoCare’s hemato-oncology strategy, supporting near-term revenue growth with a pipeline of differentiated, late-stage therapies.

Orelabrutinib
Orelabrutinib serves as a backbone therapy in InnoCare’s extensive hemato-oncology pipeline. Its newly approved 1L CLL/SLL indication has been included in the NRDL and is recommended as a Class I treatment in the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines for Malignant Lymphoma. With all four approved indications now covered under the NRDL, orelabrutinib offers stable annual treatment costs, benefiting more lymphoma patients.

The commercial team further strengthened execution capabilities and sharpened strategic focus, delivering strong sales performance throughout 2025. Improved market penetration and operational discipline laid a solid foundation for sustained revenue growth and long-term commercial success.

Internationally, orelabrutinib continued to expand its regulatory footprint, with approval granted for relapsed or refractory marginal zone lymphoma (R/R MZL) in Singapore and NDA submission for R/R MCL successfully completed in Australia.

Tafasitamab
In May 2025, the tafasitamab regimen received NDA approval for adult patients with R/R DLBCL, representing the first CD19 antibody therapy approved in China for this indication and a key addition to InnoCare’s commercial portfolio.

Building on the initial commercial launch in September 2025, 2026 will mark the first full year of tafasitamab sales in China. Moreover, tafasitamab has been included as a Class II recommendation in the CSCO Guidelines, which will help address unmet clinical needs in this patient population and provide meaningful benefits.

Mesutoclax (ICP-248)
As the first BCL2 inhibitor granted BTD in China, mesutoclax has rapidly advanced across multiple registrational studies. The Phase III combination regimen with orelabrutinib for 1L CLL/SLL completed patient enrollment within 10 months, demonstrating strong clinical execution. This fixed-duration combination regimen has the potential to deliver deeper remissions, bringing hope for clinical cure and representing a promising treatment option.

A registrational trial in BTK inhibitor-treated MCL is progressing rapidly, and a Phase III randomized, double-blind, multicenter study of mesutoclax in combination with orelabrutinib versus pirtobrutinib (a reversible BTK inhibitor) in r/r MCL is expected to commence in 2026.

Global development of mesutoclax in AML and MDS is progressing across China, U.S., and Australia. The global AML and MDS markets are projected to reach US$8 billion3 and US$11 billion4 by 2034 respectively.

Mesutoclax, as a monotherapy or in combination with orelabrutinib, demonstrated a favorable safety profile for CLL/SLL across all dose levels tested. In the CLL/SLL patients receiving mesutoclax in combination with orelabrutinib, the overall response rate (ORR) was 100%, the complete response rate (CRR) was 57.1%, and the peripheral blood uMRD rate at 36-week was 65%. The clinical data from mesutoclax monotherapy demonstrated potential best in class efficacy in MCL patients, particularly in heavily treated patients with BTK inhibitor refractory. Among MCL patients who were BTK inhibitor-refractory, the ORR was 84.0% and the CRR was 36.0%. Mesutoclax in combination with orelabrutinib demonstrated a consistently favorable safety profile across B-cell malignancies (MCL, MZL, CLL/SLL). This oral, chemo-free regimen has the potential to establish a novel therapeutic option for B-NHLs. Updated data will be presented at 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

The combination of mesutoclax and azacitidine demonstrated a favorable safety profile and encouraging anti-tumor activity not only in AML but also in MDS patients. Among 35 evaluable treatment-naive AML patients, the regimen achieved an 85.7% composite CR rate and an 86.7% uMRD rate, with no mortality observed with 90 days. Preliminary data among MDS patients is also promising. There were no dose-limiting toxicities (DLT) or tumor lysis syndrome (TLS) events. Detailed data to be presented at 2026 ASCO (Free ASCO Whitepaper) annual meeting.

Developing B-cell and T-cell Pathways in Autoimmune Diseases

Autoimmune diseases can affect almost every organ in the body and may arise at any stage of life. The global market for autoimmune disease therapeutics is anticipated to reach $185 billion by 20295. The Company has fortified its powerful discovery engine on cutting-edge global targets for the development of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments to address the massive unmet clinical needs and strong market potential in China and globally.

Orelabrutinib
Immune Thrombocytopenia (ITP): With over 200,000 new cases globally each year, including 60,000 in China, ITP represents a significant unmet medical need. The pivotal Phase III study has been completed, and the Company expects to submit the NDA application in the first half of 2026. ITP represents an important expansion of orelabrutinib from hematologic malignancies into autoimmune hematologic diseases, unlocking its enormous commercial potential. By leveraging the BTK inhibitor’s advantage in ITP, such as decreased macrophage-mediate platelet destruction and reduced production of pathogenic autoantibodies, orelabrutinib is well positioned to become a preferred BTK inhibitor in the field of ITP.

Systemic lupus erythematosus (SLE): There are about 8 million SLE patients worldwide. Orelabrutinib is the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE. The Phase IIb study met its primary endpoint, and a Phase III registrational study was initiated in the first quarter of 2026. Under stringent steroid-tapering requirements, orelabrutinib 75 mg once daily (QD) achieved a statistically significant improvement in SLE Response Index-4 (SRI-4) rate compared with placebo at Week 48 (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. In a higher disease activity subgroup (BILAG ≥1A or ≥2B; SLEDAI-2K score ≥4), the 75 mg QD group achieved SRI-4 response rate of 68%, representing a 43% absolute improvement over placebo. Notably, 71.1% of patients in the 75 mg group achieving steroid reduction to ≤7.5 mg, compared with 43.6% in the placebo group.

Multiple Sclerosis (MS): The US SPMS and PPMS market exceeds US$12 billion6, representing a significant commercial opportunity. Based on the deal, InnoCare has been cooperating with Zenas to accelerate two global Phase III clinical trials of orelabrutinib for the treatment of PPMS and SPMS, further unleashing its global value in autoimmune diseases.

Initiated Orelabrutinib PriMroSe PPMS trial, a Phase III, global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orelabrutinib in patients with PPMS in the third quarter of 2025. More information on the Phase III PriMroSe trial (NCT07067463) is available at clinicaltrials.gov.
Orelabrutinib Monarch trial for non-active SPMS (naSPMS) is planned, a Phase III, global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orelabrutinib in patients with naSPMS is expected to initiate in the first quarter of 2026. More information on the Phase III Monarch trial (NCT07299019) is available at clinicaltrials.gov.
Two TYK2 Inhibitors
The global dermatology drug market has enormous potential, with over 500 million patients suffering from dermatological diseases worldwide. By 2035, the global dermatology market size is projected to reach nearly US$100 billion. InnoCare is well positioned to capture this opportunity with two TYK2 inhibitors targeting multiple high-value indications, including atopic dermatitis (AD), psoriasis, vitiligo, nodular prurigo (PN), urticaria (CSU), cutaneous lupus erythematosus (CLE), and other dermatological diseases. The global AD market is projected to reach $30 billion7 by 2030, the vitiligo market $3 billion8 by 2032, the CSU market $3 billion9 by 2029, the psoriasis market $58 billion10 by 2032, the PN market $3 billion11 by 2034, and CLE market US$ 7.9 billion12 by 2032.

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6 Zenas estimate based on reported prevalence and current pricing of B cell therapies approved for MS
7 Grand View Research
8 Data Bridge Market Research
9 The Business Research Company
10 Fortune Business Insights
11 Global Market Insights
12 Data Bridge Market Research

Soficitinib (ICP-332)
The Phase III clinical study of soficitinib in patients with moderate to severe atopic dermatitis (AD) completed patient enrollment, with data readout expected in mid-2026. The Phase II clinical study of soficitinib in patients with vitiligo has also completed patient enrollment. Additional studies in prurigo nodular, urticaria, and psoriasis are progressing rapidly. As a result, soficitinib is expected to deliver a series of clinically meaningful data catalysts in 2026.

Data from the Phase II clinical trial of soficitinib in patients with moderate-to-severe AD were published in JAMA Dermatology in January 2026. The journal concluded that soficitinib demonstrated a favorable safety profile and encouraging efficacy in patients with AD.

Soficitinib achieved multiple efficacy endpoints in the study. The percentage improvement from baseline in EASI at Week 4 were 78.2% in the soficitinib 80 mg group, 72.5% in the soficitinib 120 mg group, and 16.7% for those receiving placebo. There was a statistically significant higher EASI-75 response rate with both soficitinib doses (64.0% for each; difference vs placebo, 56.0%) than with placebo and a greater percentage of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA) score of 0 or 1 and improvement of 2 or more points at Week 4 in the soficitinib 80 mg group vs placebo (36.0%; difference vs placebo, 32.0%, P=0.005). Meanwhile, soficitinib demonstrated rapid relief of pruritus and significant improvement in quality of life. Substantial reductions in Pruritus NRS severity and frequency scores were observed on Day 2 of treatment compared to placebo, with continued improvement over time, peaking at Week 4 for both severity and frequency (all P<0.05).

ICP-488
The Phase III clinical study in psoriasis has completed patient enrollment, and the Phase II trial for CLE is progressing rapidly. The IND for Sjögren’s syndrome has been submitted, and additional indications and combination strategies are under evaluation.

Data on ICP-488 for the treatment of patients with moderate-to-severe plaque psoriasis has been released at the 2025 AAD Annual Meeting as a late-breaking oral presentation. The study results demonstrated that ICP-488 is highly effective in treating psoriasis at both the 6 mg QD and 9 mg QD doses. Moreover, ICP-488 exhibited favorable safety and tolerability profiles, reinforcing its potential as a valuable treatment option for moderate-to-severe psoriasis patients.

At week 12, the percentage of patients achieving PASI 75 was significantly superior in the ICP-488 6 mg QD group (77.3%) and the 9 mg QD group (78.6%) than that of the placebo group (11.6%); the percentages of subjects achieving PASI 90 and sPGA of 0 (clear) or 1 (almost clear) were also significantly higher in the ICP-488 6 mg QD group (36.4%, 70.5%) and 9 mg QD group (50.0%, 71.4%) compared to the placebo group (0%, 9.3%).

ICP-538
The first healthy volunteer has been dosed in a clinical trial of ICP-538, a VAV1-directed molecular glue degrader (MGD), in China. This is the first VAV1 degrader approved to enter clinical trials in China. ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 induces rapid and efficient degradation of the VAV1 protein in a dose-dependent manner by selectively mediating the formation of a ternary complex between the CRBN E3 ubiquitin ligase and the VAV1 protein. ICP-538 will be developed for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus, and multiple sclerosis. Currently, there are no approved VAV1-targeted therapies globally.

ICP-054
The IND application of ICP-054 (ZB021), a novel oral IL-17AA/AF inhibitor, was submitted. ICP-054 is a novel, oral, highly potent and selective IL-17AA/AF inhibitor with significant therapeutic potential in autoimmune and inflammatory diseases. ICP-054 can effectively block the signal transduction pathways of IL-17AA homodimer and IL-17AF heterodimer, thereby inhibiting the release of pro-inflammatory cytokines and chemokines, exerting an anti-inflammatory effect. Simultaneously, it reduces excessive proliferation of keratinocytes and inflammatory cell infiltration, improving skin lesions and thus suppressing the occurrence of autoimmune and inflammatory diseases.

Under the BD agreement, Zenas holds exclusive rights to develop, manufacture and commercialize the oral, IL-17AA/AF inhibitor in all territories outside Greater China and Southeast Asia.

Building Innovative Solid Tumor Assets

InnoCare has been building a robust and diversified portfolio to address significant unmet medical needs across multiple tumor types. The Company is committed to combining targeted small molecules with next-generation antibody-drug conjugates (ADCs) to maximize clinical benefit while minimizing systemic toxicity. The R&D team aims to focus on tumor types with high unmet needs, and to develop therapies that are differentiated in mechanism of action, potency, and safety profile. InnoCare’s proprietary ADC technology platform, alongside promising precision medicine candidates like zurletrectinib, positions the Company to establish a strong presence in the field of solid tumor treatment.

Zurletrectinib (ICP-723)
Zurletrectinib, a next generation TRK inhibitor, represents InnoCare’s first approved therapy in solid tumors and its third innovative product approved for marketing. Zurletrectinib is indicated for adult and adolescent patients (12–18 years) with NTRK gene fusion-positive tumors.

In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy and a favorable safety profile. The study results showed an ORR of 89.1%, a disease control rate (DCR) of 96.4%, and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively.

InnoCare expects to submit NDA for pediatric patients (2 years < 12 years) in the second quarter of 2026.

In-House Developed Antibody-Drug Conjugate (ADC) Platform

The Company has developed a cutting-edge ADC platform with proprietary linker-payload (LP) technologies, aimed at the delivery of potent and targeted therapies for cancer treatment. This platform allows for the creation of highly differentiated ADCs with improved efficacy and safety profiles. Key features of the platform include:

Irreversible bioconjugation: ensuring stable antibody-linker bioconjugation for improved stability.
Hydrophilic linker: enhancing ADC stability and achieving a high drug-to-antibody ratio (DAR) of 8.
Novel payload: incorporating highly potent cytotoxic payloads with a strong bystander killing effect.
The platform is expected to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology.

ICP-B794: A Novel B7-H3 Targeted ADC for Solid Tumors
InnoCare is advancing the Phase I dose escalation trial of novel B7-H3 targeted ADC, ICP-B794. ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to a potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others. ICP-B794 has demonstrated superior anti-tumor activity in animal models compared with other ADCs, and exhibited significant tumor-killing effects even in large tumors.

Early clinical observations indicate favorable pharmacokinetics and tolerability, with preliminary signs of antitumor activity, which validate the Company’s proprietary ADC platform for solid tumor development.

ICP-B208: A Novel CDH17 Targeted ADC for Solid Tumors
Building on the encouraging efficacy and safety of ICP-B794, the second ADC candidate, ICP-B208, is designed to target CDH17, a calcium-dependent cell adhesion protein that plays a key role in tumor cell proliferation, migration, and metastasis. Its tumor-restricted expression and functional role in cancer biology make CDH17 an attractive and differentiated target for ADC therapy, enabling the delivery of potent cytotoxic payloads specifically to tumor cells while minimizing systemic toxicity, which can be developed for the treatment of gastrointestinal cancers, including gastric, colorectal, pancreatic ductal adenocarcinoma, and cholangiocarcinoma. Preclinical studies show that ICP-B208 demonstrates good anti-tumor activity even in CDH17-low tumors. The IND application has been submitted in March 2026.

InnoCare plans to submit at least two more ADC INDs within 2026, further expanding its differentiated solid tumor pipeline.

To know more about the detailed financial data and business updates of InnoCare 2025 annual results, please log in to View Source .

Conference Call Information
InnoCare will host a conference call at 8:30 p.m. Beijing time on March 25 in English and at 9:00 a.m. Beijing time in Chinese on March 26, 2025. Participants must register in advance of the conference call. Details are as follows:

For English conference call, please register through the below link:
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For Chinese conference call, please register through the below link:
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(Press release, InnoCare Pharma, MAR 25, 2026, View Source [SID1234663920])

On March 25, 2026 Boehringer Ingelheim reported the company successfully delivered on key launches in its Human Pharma business in 2025, bringing two medicines with FDA Breakthrough Therapy designation for lung cancer and pulmonary fibrosis to market in H2, 2025. Group sales rose by 7.3%* to EUR 27.8 billion ($31.4 billion) for the full year, supported by both the Human Pharma and Animal Health business. In 2025, Boehringer increased Research and Development (R&D) investments to EUR 6.4 billion ($7.2 billion), representing 22.9% of group net sales. The company reached 70 million patients in 2025, delivering innovative medicines to more patients than ever before.

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"2025 reinforced the strength of our pipeline and underscored the impact of our long-term investment in R&D. With two newly launched medicines in oncology and respiratory, we are addressing high unmet medical needs of patients, while also driving the renewal of our portfolio. Our pipeline positions us well to continue to make a real difference across important disease areas, and to bring innovative therapies to more patients than ever," said Shashank Deshpande, Chairman of the Board of Managing Directors and responsible for Human Pharma. "As 2026 unfolds with pivotal Phase III programs and readouts as well as new launches ahead, we strive to improve the lives of patients, animals, and communities worldwide."

Frank Hübler, Member of the Board of Managing Directors responsible for Finance, added: "In volatile markets and amid regional challenges, our business proved resilient as we focused on what we do best: bringing more medicines to patients and animals. We are investing more than ever in innovation, which reflects our ambition for the next years."

Human Pharma: JARDIANCE (empagliflozin tablets) and OFEV (nintedanib capsules) continue to grow; HERNEXEOS and JASCAYD launched
Human Pharma sales rose 7.4%* to EUR 22.7 billion ($25.6 billion), supported by strong performance in its core brands. JARDIANCE (empagliflozin tablets), for the treatment of chronic kidney disease, type 2 diabetes and heart failure, grew 8.7%* to EUR 8.8 billion ($9.9 billion). OFEV (nintedanib capsules), used to treat idiopathic pulmonary fibrosis and other progressive fibrosing interstitial lung diseases, increased 5.4%* to EUR 3.8 billion ($4.3 billion).

Boehringer Ingelheim expanded its portfolio with the launch of two innovative therapies in 2025: HERNEXEOS (zongertinib tablets), an oral treatment for HER2-mutant advanced non-small cell lung cancer, was launched in the U.S. in August 2025. The company also launched JASCAYD (nerandomilast tablets), which was approved in the U.S. and China for idiopathic pulmonary fibrosis (IPF) in October 2025, and for progressive pulmonary fibrosis (PPF) in December 2025. JASCAYD represents the first new innovative therapy for IPF coming to market in more than a decade.

Human Pharma R&D investments came in at EUR 5.8 billion ($6.6 billion) or 27.4% of the unit’s net sales. The company continued to advance its pipeline across cardiovascular, renal and metabolic diseases (CRM), oncology, respiratory and immunology, mental health, and eye health. The pipeline today includes more than 80 projects, representing over 50 new molecular entities. Ongoing advances in Boehringer’s growing mid‑ and late‑stage pipeline are building towards a sustained wave of potential launches, positioning the company to deliver transformative impact for patients in the years to come.

Animal Health: preventing the spread of transboundary animal diseases
In 2025, the Animal Health business demonstrated resilience and impact, with sales rising 6.5%* to EUR 4.9 billion ($5.5 billion). Growth was driven by pet parasiticides and therapeutics, poultry, and ruminant segments, with NEXGARD growing 8.5%* to EUR 1.4 billion ($1.6 billion), cementing its position as the industry’s top-selling parasiticide brand.

The company worked side by side with farmers, veterinarians, and governments, to help combat livestock diseases such as avian influenza, foot-and-mouth disease, and bluetongue virus. Boehringer received EU Marketing Authorization under Exceptional Circumstances for two poultry vaccines, supporting producers in keeping their poultry flocks healthy and increasing preparedness for avian influenza outbreaks. In addition to the VAXXINACT H5 avian influenza vaccine, VAXXITEK HVT+IBD+H5 is a new trivalent vaccine protecting chickens and turkeys against Marek’s disease, Infectious Bursal Disease and H5 avian influenza.

Outlook
In 2026, Boehringer expects to build on the momentum of recent years with continued progress across the Animal Health and Human Pharma pipelines and critical inflection points particularly in CRM, oncology and eye health.
* sales growth numbers are adjusted for currency effects.

(Press release, Boehringer Ingelheim, MAR 25, 2026, View Source [SID1234663998])

On March 25, 2026 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported financial results for the fourth quarter and year ended December 31, 2025.

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"2025 was a year of strategic importance for Nkarta as we onboarded a clinical team with deep autoimmune experience, right-sized our workforce to be a responsible steward of investor capital, and continued to advance our CAR-NK cell therapy platform through dose escalation in the clinic," said Paul J. Hastings, Chief Executive Officer of Nkarta. "Thoughtfully leveraging our safety data, we are now dosing patients at 4 billion cells in a three-dose cycle for a total of 12 billion cells as we look to maximize the depth and durability of B-cell depletion and clinical response, positioning us to unlock the full potential of NKX019 for people living with autoimmune disease."

"We look forward to sharing a comprehensive clinical update from Ntrust-1 and Ntrust-2 later this year with the aim of presenting a meaningful data set at a medical conference. With cash projected to fund operations into 2029, we remain focused on disciplined clinical execution as we continue enrollment in our Ntrust-1 and Ntrust-2 clinical programs."

NKX019 Clinical Program Progress and Upcoming Milestones

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Enrollment continued across Ntrust-1 and Ntrust-2, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases.
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Patients are now being dosed at 4 billion cells per dose as part of ongoing dose escalation.

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Enrollment remains open in both investigator-sponsored trials of NKX019 in generalized myasthenia gravis and systemic lupus erythematosus.
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Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference later this year.

Fourth Quarter and Full Year 2025 Financial Highlights

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Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $295.1 million as of December 31, 2025.
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Research and development (R&D) expenses were $90.4 million for the full year 2025 and $25.3 million for the fourth quarter of 2025. Non-cash stock-based compensation expense included in R&D expense was $3.2 million for the full year 2025 and $0.7 million for the fourth quarter of 2025.
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General and administrative (G&A) expenses were $31.6 million for the full year 2025 and $5.7 million for the fourth quarter of 2025. Non-cash stock-based compensation expense included in G&A expense was $5.4 million for the full year 2025 and $1.2 million for the fourth quarter of 2025.
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Net loss was $104.1 million, or $1.41 per basic and diluted share, for the full year 2025. This net loss includes non-cash charges of $14.4 million that consisted primarily of share-based compensation, right-of-use asset impairment and depreciation expenses. Net loss was $27.4 million, or $0.37 per basic and diluted share, for the fourth quarter of 2025. This net loss includes non-cash charges of $3.3 million that consisted primarily of share-based compensation and depreciation expenses.

Financial Guidance

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Nkarta expects its current cash and cash equivalents to fund its current operating plan into 2029.

About the Ntrust℠ Clinical Trials in Autoimmune Disease

Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open label, dose escalation clinical trials in patients with autoimmune disease receiving lymphodepletion followed by CD19-targeted CAR-NK cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its potential to achieve durable remission via a "reset" of the immune system through the elimination of pathogenic B cells.

The Ntrust trials are enrolling up to 12 patients per dose level per disease indication across systemic sclerosis, idiopathic inflammatory myopathy, ANCA-associated vasculitis, lupus nephritis, and primary membranous nephropathy.

In both studies, patients now receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepletion with fludarabine and cyclophosphamide or cyclophosphamide alone, if they have significant cytopenia at baseline. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in Ntrust-1 may also receive additional cycles, if necessary, to restore response or enable a deeper response.

About NKX019

NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

(Press release, Nkarta, MAR 25, 2026, View Source [SID1234663905])