On October 21, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV (enfortumab vedotin-ejfv) in combination with KEYTRUDA (pembrolizumab) as a neoadjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment (after surgery) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

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Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of April 7, 2026.

The sBLA submission was based on results from the pivotal Phase 3 EV-303 clinical trial (also known as KEYNOTE-905) evaluating PADCEV, a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA, a PD-1 inhibitor, as neoadjuvant and adjuvant treatment versus surgery alone, the current standard of care. Detailed results from EV-303, which showed the combination reduced the risk of recurrence, progression or death by 60% and the risk of death by 50% compared to surgery alone, were presented at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The safety results in EV-303 were consistent with those previously reported for this combination, and no new safety signals were identified.

About the EV-303/KEYNOTE-905 Trial
The EV-303 trial (also known as KEYNOTE-905) is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA or neoadjuvant and adjuvant KEYTRUDA versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant KEYTRUDA (arm A), surgery alone (arm B) or neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA (arm C).1

The primary endpoint of this trial is event-free survival (EFS) between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause. Key secondary endpoints include overall survival (OS) and pathologic complete response (pCR) rate between arm C and arm B, as well as EFS, OS and pCR rate between arm A and arm B.1

For more information on the global EV-303 trial, go to clinicaltrials.gov.

About Muscle-Invasive Bladder Cancer
Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 people each year globally, including an estimated 85,000 people in the U.S.2,3 MIBC represents approximately 30% of all bladder cancer cases.4 The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival.5 However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery without any systemic treatment.6

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.7 Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).8

PADCEV plus KEYTRUDA is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, the European Union, Japan and a number of other countries around the world. PADCEV is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.8

PADCEV (enfortumab vedotin-ejfv) U.S. Indication & Important Safety Information

BOXED WARNING: SERIOUS SKIN REACTIONS 

PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.
Closely monitor patients for skin reactions.
Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.
Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.
Indication 
PADCEV, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC). 

PADCEV, as a single agent, is indicated for the treatment of adult patients with locally advanced or mUC who: 

have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or
are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
PADCEV Important Safety Information 

Warnings and Precautions 

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 70% (all grades) of the 564 patients treated with PADCEV in combination with pembrolizumab in clinical trials. When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate compared to PADCEV as a single agent. The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash. Grade 3-4 skin reactions occurred in 17% of patients (Grade 3: 16%, Grade 4: 1%), including maculo-papular rash, bullous dermatitis, dermatitis, exfoliative dermatitis, pemphigoid, rash, erythematous rash, macular rash, and papular rash. A fatal reaction of bullous dermatitis occurred in one patient (0.2%). The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Skin reactions led to discontinuation of PADCEV in 6% of patients. 

Skin reactions occurred in 58% (all grades) of the 720 patients treated with PADCEV as a single agent in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 34% had pruritus. Grade 3-4 skin reactions occurred in 14% of patients, including maculo-papular rash, erythematous rash, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. The median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 8 months). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=75), 24% of patients restarting at the same dose and 24% of patients restarting at a reduced dose experienced recurrent severe skin reactions. Skin reactions led to discontinuation of PADCEV in 3.1% of patients. 

Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. For persistent or recurrent Grade 2 skin reactions, consider withholding PADCEV until Grade ≤1. Withhold PADCEV and refer for specialized care for suspected SJS, TEN or for Grade 3 skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. 

Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre-existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials of PADCEV as a single agent, 17% of the 720 patients treated with PADCEV developed hyperglycemia of any grade; 7% of patients developed Grade 3-4 hyperglycemia (Grade 3: 6.5%, Grade 4: 0.6%). Fatal events of hyperglycemia and DKA occurred in one patient each (0.1%). The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. The median time to onset of hyperglycemia was 0.5 months (range: 0 to 20 months). Hyperglycemia led to discontinuation of PADCEV in 0.7% of patients. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. Of the patients who initiated insulin therapy for treatment of hyperglycemia, 66% (23/35) discontinued insulin at the time of last evaluation. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV. 

Pneumonitis/Interstitial Lung Disease (ILD) Severe, life-threatening or fatal pneumonitis/ILD occurred in patients treated with PADCEV. When PADCEV was given in combination with pembrolizumab, 10% of the 564 patients treated with combination therapy had pneumonitis/ILD of any grade and 4% had Grade 3-4. A fatal event of pneumonitis/ILD occurred in two patients (0.4%). The incidence of pneumonitis/ILD, including severe events, occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of any grade pneumonitis/ILD was 4 months (range: 0.3 to 26 months). 

In clinical trials of PADCEV as a single agent, 3% of the 720 patients treated with PADCEV had pneumonitis/ILD of any grade and 0.8% had Grade 3-4. The median time to onset of any grade pneumonitis/ILD was 2.9 months (range: 0.6 to 6 months). 

Monitor patients for signs and symptoms indicative of pneumonitis/ILD such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis/ILD. 

Peripheral neuropathy (PN) When PADCEV was given in combination with pembrolizumab, 67% of the 564 patients treated with combination therapy had PN of any grade, 36% had Grade 2 neuropathy, and 7% had Grade 3 neuropathy. The incidence of PN occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of Grade ≥2 PN was 6 months (range: 0.3 to 25 months). 

PN occurred in 53% of the 720 patients treated with PADCEV as a single agent in clinical trials including 38% with sensory neuropathy, 8% with muscular weakness and 7% with motor neuropathy. Thirty percent of patients experienced Grade 2 reactions and 5% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN. The median time to onset of Grade ≥2 PN was 4.9 months (range: 0.1 to 20 months). Neuropathy led to treatment discontinuation in 6% of patients. 

Monitor patients for symptoms of new or worsening PN and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade ≥3 PN. 

Ocular disorders were reported in 40% of the 384 patients treated with PADCEV as a single agent in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry eye symptoms occurred in 30% of patients, and blurred vision occurred in 10% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.7 months (range: 0 to 30.6 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders. 

Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 1% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions. 

Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose. 

ADVERSE REACTIONS 

Most common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV in combination with pembrolizumab) 
Increased aspartate aminotransferase (AST), increased creatinine, rash, increased glucose, PN, increased lipase, decreased lymphocytes, increased alanine aminotransferase (ALT), decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection and decreased platelets. 

Most common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV monotherapy) 
Increased glucose, increased AST, decreased lymphocytes, increased creatinine, rash, fatigue, PN, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased ALT, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, dry skin. 

EV-302 Study: 440 patients with previously untreated la/mUC (PADCEV in combination with pembrolizumab) 
Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab. The most common serious adverse reactions (≥2%) were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Fatal adverse reactions occurred in 3.9% of patients treated with PADCEV in combination with pembrolizumab including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%). 

Adverse reactions leading to discontinuation of PADCEV occurred in 35% of patients. The most common adverse reactions (≥2%) leading to discontinuation of PADCEV were PN (15%), rash (4.1%) and pneumonitis/ILD (2.3%). Adverse reactions leading to dose interruption of PADCEV occurred in 73% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were PN (22%), rash (16%), COVID19 (10%), diarrhea (5%), pneumonitis/ILD (4.8%), fatigue (3.9%), hyperglycemia (3.6%), increased ALT (3%) and pruritus (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 42% of patients. The most common adverse reactions (≥2%) leading to dose reduction of PADCEV were rash (16%), PN (13%) and fatigue (2.7%). 

EV-103 Study: 121 patients with previously untreated la/mUC who were not eligible for cisplatin-containing chemotherapy (PADCEV in combination with pembrolizumab) 
Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab; the most common (≥2%) were acute kidney injury (7%), urinary tract infection (7%), urosepsis (5%), sepsis (3.3%), pneumonia (3.3%), hematuria (3.3%), pneumonitis/ILD (3.3%), urinary retention (2.5%), diarrhea (2.5%), myasthenia gravis (2.5%), myositis (2.5%), anemia (2.5%), and hypotension (2.5%). Fatal adverse reactions occurred in 5% of patients treated with PADCEV in combination with pembrolizumab, including sepsis (1.6%), bullous dermatitis (0.8%), myasthenia gravis (0.8%), and pneumonitis/ILD (0.8%). Adverse reactions leading to discontinuation of PADCEV occurred in 36% of patients; the most common (≥2%) were PN (20%) and rash (6%). Adverse reactions leading to dose interruption of PADCEV occurred in 69% of patients; the most common (≥2%) were PN (18%), rash (12%), increased lipase (6%), pneumonitis/ILD (6%), diarrhea (4.1%), acute kidney injury (3.3%), increased ALT (3.3%), fatigue (3.3%), neutropenia (3.3%), urinary tract infection (3.3%), increased amylase (2.5%), anemia (2.5%), COVID19 (2.5%), hyperglycemia (2.5%), and hypotension (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 45% of patients; the most common (≥2%) were PN (17%), rash (12%), fatigue (5%), neutropenia (5%), and diarrhea (4.1%). 

EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy (PADCEV monotherapy) 
Serious adverse reactions occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each), and pneumonia (5%). Fatal adverse reactions occurred in 3% of patients, including multiorgan dysfunction (1%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis/ILD, and pelvic abscess (0.3% each). Adverse reactions leading to discontinuation occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions leading to dose interruption occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%), and fatigue (9%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite, and fatigue (3% each). 

EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for cisplatin-based chemotherapy (PADCEV monotherapy) 
Serious adverse reactions occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis, and diarrhea (5% each). Fatal adverse reactions occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia, and pneumonitis/ILD (1.1% each). Adverse reactions leading to discontinuation occurred in 20% of patients; the most common (≥2%) was PN (7%). Adverse reactions leading to dose interruption occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), increased AST, and hyperglycemia (3% each). Adverse reactions leading to dose reduction occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%), and fatigue (7%). 

DRUG INTERACTIONS 
Effects of other drugs on PADCEV (Dual P-gp and Strong CYP3A4 Inhibitors) 
Concomitant use with dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors. 

SPECIFIC POPULATIONS 
Lactation Advise lactating women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose. 

Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment. 

(Press release, Astellas Pharma, OCT 22, 2025, View Source [SID1234656879])

On October 21, 2025 Innovent Biologics (HKEX: 01801) reported a strategic global collaboration with Takeda (TSE:4502, NYSE:TAK) to advance next-generation IO and ADC cancer therapies, with the goal of developing potentially transformative cancer treatments to benefit patients worldwide.

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This partnership aims to leverage key synergies and accelerate the global development of several investigational medicines within Innovent’s IO+ADC pipeline, including: IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein demonstrating robust anti-tumor activity and potential to be a foundational next-generation IO therapy that is currently in Phase 3 clinical stage; IBI343, a potentially best-in-class CLDN18.2 ADC currently in Phase 3 clinical stage; and IBI3001, a first-in-class EGFR/B7H3 bispecific ADC currently in Phase 1 clinical stage.

Dr. Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent Biologics, stated,

"We believe that developing innovative IO and ADC will be a key direction for redefining cancer treatment worldwide. This landmark collaboration with Takeda brings together our three next-generation assets. With clear, aligned development plans, Innovent’s deep understanding of these assets, combined with Takeda’s extensive experience and strong development and commercialization capabilities, we are committed to delivering these promising medicines to patients worldwide as quickly as possible. This collaboration is also a crucial step in fulfilling Innovent’s strategic roadmap as we expand our global footprint, with the goal of becoming a leading global biopharmaceutical company."

"We are excited to partner with Innovent, an accomplished team with deep expertise in next-generation immuno-oncology and ADC biology," said Teresa Bitetti, President of the Global Oncology Business Unit at Takeda. "IBI363 and IBI343, two next-generation investigational medicines, have the potential to address critical treatment gaps for patients with a range of solid tumors. We are energized by the progress made by Innovent to date and look forward to collaborating to unlock the potential of these programs. Our global research and development expertise and commercialization capabilities will enable us to accelerate the delivery of these investigational medicines to patients. These two programs have the potential to be transformative for our oncology portfolio and significantly enhance Takeda’s growth potential post-2030."

IBI363 (PD-1/IL-2α-bias): Global Joint Development and Commercialization Collaboration

IBI363, developed by Innovent Biologics, is a potentially first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein that simultaneously blocks the PD-1/PD-L1 pathway and activates the IL-2 pathway. Innovent has shown that IBI363, with an IL-2 receptor alpha focused approach, selectively expands tumor-specific CD8+ T cells that increase tumor cell killing efficiency without activating or expanding the toxicity related to peripheral T cells, which results in a better safety profile than what is seen with traditional IL-2s. Phase 1b/2 results presented at ASCO (Free ASCO Whitepaper) 2025 have demonstrated outstanding tumor responses and preliminary survival benefits of IBI363 across immunotherapy-resistant lung cancer, "cold tumors" such as acral and mucosal melanoma, and MSS colorectal cancer. IBI363 is now in registrational clinical development, including a global Phase 3 study in second line sqNSCLC that is expected to begin in the coming months; the China NMPA has granted Breakthrough Designation (BTD) and U.S. FDA has granted Fast Track Designation (FTD) for this indication.

According to the agreement, Innovent and Takeda will co-develop IBI363 globally, sharing development costs 40/60 (Innovent/Takeda). In the U.S., Innovent and Takeda will co-commercialize IBI363, sharing the U.S. profit or loss 40/60. Takeda will lead the co-development and co-commercialization efforts under joint governance and aligned development plan. In addition, Innovent will grant Takeda commercialization rights outside Greater China and the U.S. Takeda will have global manufacturing rights to supply IBI363 outside of Greater China, with such rights being co-exclusive with Innovent for commercial supply in the U.S. Takeda will pay Innovent potential development and sales milestones outside Greater China, and tiered royalties up to high-teens on net sales outside Greater China and the U.S.

This collaboration aims to explore and maximize IBI363’s potential as a new IO backbone therapy through aligned co-development plans. Building on its already robust clinical data of over 1,200 treated patients, IBI363 will be initially developed globally in non-small cell lung cancer ("NSCLC") and colorectal cancer ("CRC"), including in the first-line settings. Additionally, Takeda and Innovent plan to expand IBI363’s clinical development to additional indications.

IBI343 (CLDN18.2 ADC): Global License for Development and Commercialization

IBI343, developed by Innovent Biologics, is an innovative TOPO1 inhibitor ADC targeting CLDN18.2. Clinical data show a favorable safety profile and encouraging efficacy signals. It is currently being evaluated in a Phase 3 clinical trial in gastric/gastroesophageal cancers (G-HOPE-001) in China and Japan, and was granted Breakthrough Designation in China. IBI343 also completed a global Phase 1/2 trial in previously treated pancreatic ductal adenocarcinoma (PDAC) and has received Breakthrough Designation in China for this indication. It has also received Fast Track Designation from the U.S. FDA for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy.

Innovent will grant Takeda exclusive global rights to develop, manufacture and commercialize IBI343 outside of Greater China. Takeda plans to advance the development of IBI343 and expand into first-line gastric and pancreatic cancer settings.

(Press release, Innovent Biologics, OCT 21, 2025, View Source [SID1234656878])

Takeda will make potential milestone payments, and tiered royalties on net sales up to high-teens for the license of IBI343.

IBI3001 (EGFR/B7H3 ADC): Option to Global License for Development and Commercialization

IBI3001, currently in a Phase 1 clinical trial, is a first-in-class bispecific ADC targeting B7-H3 and EGFR. It combines multiple anti-tumor mechanisms, including enhanced EGFR blockade, receptor-mediated internalization, and strong ADC-mediated cytotoxicity, with a high safety margin demonstrated in preclinical models.

Innovent will grant Takeda an exclusive option to license global development, manufacturing, and commercialization rights for IBI3001 outside of Greater China. If exercised, Takeda will pay Innovent an exercise fee, potential milestone payments, and tiered royalties on net sales up to mid-teens.

Financial Highlights: Total Deal Value up to $11.4Billion

Takeda will pay Innovent an upfront payment of US$1.2 billion, including a US$100 million equity investment in Innovent through new share issuance, at HK$112.56 per share, a 20% premium to the Innovent 30-trading-day weighted average share price.

Furthermore, Innovent is eligible for development and sales milestone payments for IBI363, IBI343, and IBI3001 (if option exercised) totaling up to approximately $10.2 billion, for a total deal value of up to $11.4 billion. Innovent will also receive potential royalty payments for each molecule outside Greater China, except with respect to IBI363 in the U.S., where the parties will share profits or losses.

Innovent will host conference calls and webcasts at 9:00 a.m. HKT (Chinese session) and 9:00 p.m. HKT (English session) on Wednesday, October 22, 2025.Details of the conference call dial-in and the webcast link will be provided on the company website at View Source A replay will also be available on the website shortly after the event.

Morgan Stanley Asia Limited serves as the exclusive financial advisor to Innovent Biologics in relation to this transaction.

On October 21, 2025 Xspray pharma reported XS003 is an improved formulation of nilotinib (Tasigna) for the treatment of chronic myeloid leukemia (CML), developed using Xspray’s proprietary HyNap technology. Data demonstrate bioequivalence to the reference product at less than half the dose, as well as a significantly reduced food effect (29% compared to 82% for Tasigna). The food effect associated with the reference product complicates patient adherence and is related to the requirement that the patient must be in a fasting state, which is included in its so-called "boxed warning" regarding QTc prolongation and the risk of sudden death. The significantly reduced food effect with XS003 means it is expected that it may be taken with or without food and thereby avoid warning text regarding food interaction. Any final labeling and related warnings will be determined by the FDA during the review process.

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"The FDA’s decision to accept our NDA for review marks an important milestone," says Per Andersson, CEO of Xspray Pharma. "With two product candidates under FDA review, we are demonstrating that the HyNap platform has broad applicability and the potential to deliver more improved TKIs to the market."

Together with the company’s first product candidate Dasynoc, XS003 addresses a U.S. market of approximately USD 2.7 billion. The FDA’s notification confirms that the application is complete and that a full review is now underway. XS003 is manufactured at the same external facility as Dasynoc.

"Since the FDA now has a solid understanding of our manufacturing process, I am confident that the upcoming Pre-Approval Inspection will be completed without observations. It is essentially the same process that has previously been inspected. Furthermore, we are working closely with the manufacturer to ensure that all planned improvements to the other parts of the facility that previously received observations are completed well ahead of the PDUFA date," comments CEO Per Andersson.

(Press release, Xspray, OCT 21, 2025, View Source [SID1234656877])

On October 21, 2025 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported that a global licensing and collaboration agreement with Novartis, previously announced on September 2, 2025, has now closed. Closing of the transaction was subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

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Summary of License and Collaboration Agreement

Novartis received an exclusive worldwide license to research, develop, manufacture, and commercialize ARO-SNCA, a preclinical stage program that utilizes Arrowhead’s Targeted RNAi Molecule (TRiMTM) platform for subcutaneous administration and delivery to the CNS designed to target the gene that encodes the alpha-synuclein protein as a potential treatment for patients with Parkinson’s Disease, and other synucleinopathies. Novartis may also select additional collaboration targets outside of Arrowhead’s current pipeline to be developed using the TRiMTM platform.

For all licensed programs under the agreement, Arrowhead will conduct and complete preclinical research activities necessary to enable a clinical trial application (CTA) filing. Novartis will then assume sole control over development, manufacturing, medical affairs, and commercialization activities.

Summary Financial Terms

Arrowhead will receive a $200 million upfront payment from Novartis and is also eligible to receive development, regulatory, and sales milestone payments of up to $2 billion. Arrowhead is further eligible to receive tiered royalties on commercial sales up to the low double digits.

(Press release, Arrowhead Pharmaceuticals, OCT 21, 2025, View Source [SID1234656875])

On October 21, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported it will host a conference call and webcast on Friday, October 24 at 1:30 p.m. ET (10:30 a.m. PT) to discuss initial results from the ongoing Phase 1 dose-escalation study of XmAb819, an ENPP3 x CD3 T-cell engaging bispecific antibody, in development for patients with advanced clear cell renal cell carcinoma.

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The live webcast of the conference call may be accessed through this link and through "Events & Presentations" in the Investors section of the Company’s website, located at investors.xencor.com. A recording will be available for at least 30 days.

The results will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts, during Poster Session B on Friday, October 24 from 12:30 to 4:00 p.m. ET in a poster titled "Preliminary Phase 1 safety and antitumor activity of XmAb819, a first-in-class ENPP3 x CD3 bispecific antibody, in patients with advanced clear cell renal cell carcinoma (ccRCC)."

About XmAb819

XmAb819 is a first-in-class, tumor-targeted, T-cell engaging XmAb 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC). XmAb819 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing ENPP3, an antigen highly expressed on kidney cancers. ENPP3 is a differentially expressed target, with high level expression in renal cell carcinoma (RCC) and low-level expression on normal tissues. With two tumor-antigen binding domains and one T-cell binding domain, Xencor’s XmAb 2+1 format enables antibodies to bind more avidly and selectively kill tumor cells with higher antigen density, potentially sparing normal cells. Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC.

(Press release, Xencor, OCT 21, 2025, View Source [SID1234656874])