Ascentage Pharma To Launch Global Phase III Study Of Olverembatinib In Ph+ ALL

BEIJING (dpa-AFX) - Innovent Biologics (IVBXF, 1801.HK) announced that its global strategic collaboration with Takeda (4502.T, TAK) has officially closed and become effective following the satisfaction of all closing conditions. The partnership, first announced on October 22, 2025, is designed to accelerate the worldwide development and commercialization of Innovent's next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) therapies. This includes a global partnership on IBI363 (PD-1/IL-2?-bias), IBI343 (CLDN18.2 ADC), and an option for the early-stage program IBI3001 (EGFR/B7H3 ADC).

Under the agreement, Innovent and Takeda will co-develop IBI363 globally and co-commercialize the therapy in the U.S., with Takeda leading efforts under joint governance and an aligned development plan. Innovent has granted Takeda exclusive commercialization rights for IBI363 outside Greater China and the U.S., while Takeda also holds global manufacturing rights to supply the therapy outside Greater China. In the U.S., manufacturing rights will be co-exclusive between the two companies.

Takeda has also secured exclusive global rights to develop, manufacture, and commercialize IBI343 outside Greater China. Additionally, Takeda receives an exclusive option to license global rights for IBI3001, a first-in-class EGFR/B7H3 bispecific ADC currently in Phase 1, outside Greater China.

Financial terms of the collaboration include an upfront payment of US$1.2 billion from Takeda to Innovent, which incorporates a US$100 million equity investment in Innovent through new share issuance at a premium price of HK$112.56 per share.

Innovent is further eligible for development and sales milestone payments across IBI363, IBI343, and IBI3001 (if the option is exercised), totaling up to approximately US$10.2 billion. This brings the overall deal value to as much as US$11.4 billion. Innovent will also receive potential royalty payments for each molecule outside Greater China, except for IBI363 in the U.S., where profits and losses will be shared between Innovent and Takeda on a 40/60 basis.

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Press Release

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ESMO Asia Congress and the 2025 ASH Annual Meeting

Hong Kong, Shanghai & Florham Park, NJ - Thursday, November 27, 2025: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology ("ESMO") Asia Congress 2025, taking place on December 5-7, 2025 in Singapore, and the American Society of Hematology ("ASH") Annual Meeting taking place on December 6-9, 2025 in Orlando, USA.

Results from a first-in-human study of the anti-CD47 monoclonal antibody HMPL-A83 in advanced solid tumors, as well as from the phase II part of the FRUSICA-2 registration study of the fruquintinib and sintilimab combination as a second-line treatment for locally advanced or metastatic renal cell carcinoma, will be presented at the ESMO Asia Congress 2025. Results from the phase II part of the phase II/III study of surufatinib in combination with camrelizumab and chemotherapy as a first-line treatment for metastatic pancreatic cancer will also be reported. Details of the presentations are as follows:

Final analysis of long-term results of sovleplenib's ESLIM-01 China Phase III study in in adult patients with chronic primary immune thrombocytopenia will be presented at the 2025 ASH Annual Meeting. Details of the presentation is as follows:

About Fruquintinib

Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors ("VEGFR") -1, ‑2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®.

About HMPL-A83

HMPL-A83 is an investigational IgG4-type humanized anti-CD47 monoclonal antibody that exhibits high affinity for CD47. HMPL-A83 blocks CD47 binding to Signal regulatory protein (SIRP) α and disrupts the "do not eat me" signal that cancer cells use to shield themselves from the immune system. HUTCHMED currently retains all rights to HMPL-A83 worldwide.

About Savolitinib

Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS®.

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body's immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®. HUTCHMED currently retains all rights to surufatinib worldwide.

About Sovleplenib

Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting the spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor and Fc receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders. HUTCHMED currently retains all rights to sovleplenib worldwide.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED's current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, the further clinical development for fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, its expectations as to whether any studies on fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study's inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as camrelizumab and osimertinib as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

CONTACTS

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Reference is made to the stock exchange announcement made by Zelluna ASA (the"Company") on 3 November 2025 regarding the allocation of 5,500,000 new sharesin the Company in a private placement (the "Private Placement"), divided on afirst tranche of 3,729,774 new shares ("Tranche 1") and a second tranche of1,770,226 new shares ("Tranche 2"). Reference is further made to the stockexchange announcement made by the Company on 25 November 2025 announcing thatanextraordinary general meeting of the Company had resolved, amongst otherthings,to issue the new shares in Tranche 2 of the Private Placement.

Following the issuance of the Tranche 2 shares, Takeda Ventures, Inc.'sownership interest in the Company will cross below 5 per cent.

The reduction in ownership is due to dilution as result of the PrivatePlacement.

Takeda Ventures, Inc. holds 1,238,935 shares in the Company, equal to approx.4.72 per cent of the shares and votes in the Company following completion ofTranche 2 and the Private Placement. Takeda Ventures, Inc. is ultimately ownedand controlled by Takeda Pharmaceutical Company Limited.

This disclosure is made pursuant to Section 4-2 of the Norwegian SecuritiesTrading Act.

https://newsweb.oslobors.no/message/660488

By Katherine Hamilton

Takeda Pharmaceuticals' drug Adzynma is being investigated by the U.S. Food and Drug Administration due to a death following treatment.

The FDA said Friday it has received reports of neutralizing antibodies to ADAMTS13, including one death, in patients with the blood disorder who were treated with Adzynma.

Adzynma is indicated for prophylactic or on-demand enzyme replacement therapy in patients with the blood clot disorder congenital thrombotic thrombocytopenic purpura (cTTP). ADAMTS13 is an enzyme that is essential for regulating blood clotting, and neutralizing antibodies to it can cause cTTP.

The reported death in a pediatric patient with cTTP appears to be related to Adzynma, the FDA said. The presence of neutralizing antibodies to ADAMTS13 was identified about 10 months after the patient started prophylactic treatment with Adzynma.

Current assays are unable to distinguish neutralizing antibodies to recombinant ADAMTS13 from neutralizing antibodies to endogenous ADAMTS13, the FDA noted.

Adzynma includes information on the potential risk of developing neutralizing antibodies following treatment. Neutralizing antibodies were not reported in cTTP clinical trials, and current labeling doesn't include information about postmarketing reports of neutralizing antibodies, the FDA said.

The FDA is investigating the risk of developing the antibodies with serious or fatal outcomes following treatment with Adzynma, and will evaluate the need for further regulatory action.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to the U.S. FDA in July, the European Medicines Agency (EMA) application was submitted in September

Rusfertide granted breakthrough designation for patients in Polycythemia Vera (PV) and the subject of four presentations including 52-week results of the VERIFY Phase 3 Study at ASH, the 67th Annual American Society of Hematology (ASH) meeting in December

First patient dosed in the Phase 1 trial of PN-881, a first-in-class oral IL-17 peptide antagonist

IND-enabling studies progressing as planned with triple-GLP/GIP/GCG agonists PN-477sc and PN-477o

Oral hepcidin development candidate expected to be nominated by year end

Cash, cash equivalents and marketable securities of $678.8 million as of September 30, 2025, anticipated to provide cash runway through at least end of 2028

NEWARK, CA / ACCESS Newswire / November 6, 2025 / Protagonist Therapeutics ("Protagonist" or "the Company") today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

"2025 continues to be a highly productive year with significant accomplishments in both partnered and wholly owned programs," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "In addition to the NDA and EMA submissions for icotrokinra for psoriasis, we are pleased to see our partner Johnson and Johnson expand the ICONIC program into additional IL-23 pathway relevant and validated I&I indications, namely psoriatic arthritis, ulcerative colitis, and Crohn's disease. We, along with our partner Takeda, eagerly await the presentation of the rusfertide 52-week VERIFY data at ASH in December and the NDA filing for rusfertide by year end."

"As icotrokinra and rusfertide move towards potential NDA approval and commercialization in 2026, we shift our attention to the next phase of assets emerging from our validated discovery and development platform. We are pleased to report that the first subject in the Phase 1 trial of oral IL-17 antagonist, PN-881, is dosed. Additionally, the oral and subcutaneous triple GLP/GIP/GCG agonists, PN-477o and PN-477sc, are progressing through

IND-enabling studies as planned, and we remain on track to nominate a development candidate from the oral hepcidin program by year end. I am very proud of the consistent innovation and execution capabilities of the Protagonist team," Patel said.

Third Quarter 2025 Recent Developments and Upcoming Milestones

Icotrokinra: Oral IL-23 Receptor Antagonist

• In November, publications of ICONIC-LEAD data through Week 24 (available here) and ICONIC-TOTAL data through Week 16 (available here) were published in the New England Journal of Medicine, and the NEJM Evidence, respectively.

• On October 27th, the Company and Johnson and Johnson announced Week 28 results from the Phase 2b ANTHEM-UC study of icotrokinra in adults with moderately to severely active ulcerative colitis (UC) at the 2025 ACG Annual Scientific Meeting. I cotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placebo.

• On October 26 th , new long-term 52-week data from the Phase 3 ICONIC-TOTAL study, was presented at the 2025 Fall Clinical Dermatology Conference. The data show icotrokinra demonstrated high and durable rates of site-specific psoriasis clearance affecting these high-impact and difficult-to-treat areas of the body.

• On October 7th, the Company and its partner JNJ announced Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra in adults with moderately to severely active UC at United European Gastroenterology Week (UEGW) 2025.

• On September 17th, new data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies, which assessed the superiority of icotrokinra compared to deucravacitinib in patients with moderate-to-severe plaque psoriasis (PsO), was presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. Additionally, new long-term 52-week data from the Phase 3 ICONIC-LEAD study investigating icotrokinra in adults and pediatric patients 12 years of age and older (adolescents) with moderate to severe PsO was presented as a late-breaking abstract at EADV.

• On September 11th, the Company announced the submission of an application to the European Medicines Agency (EMA) by JNJ seeking the first approval of icotrokinra for the treatment of adults and pediatric patients 12 years of age and older (adolescents) with moderate-to-severe PsO.

• On July 21st, the Company announced submission of a New Drug Application (NDA) to the U.S. FDA by JNJ seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe PsO.

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

• Clinical data on rusfertide in PV, including the Phase 3 VERIFY study, are the focus of four presentations planned at the 67 th Annual American Society of Hematology (ASH) Annual Meeting being held in Orlando, Florida from December 6-9, 2025. This includes an oral presentation of the durability of response and safety results through week 52 from the VERIFY study.

• On August 25th, the Company and its partner Takeda Pharmaceuticals announced rusfertide was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of erythrocytosis in patients with PV.

• Rusfertide U.S. NDA filing for treatment of patients with PV, by partner Takeda Pharmaceuticals, is expected in Q4 of this year.

Discovery and Development Pipeline

• The first human subject has been dosed in the Phase 1 trial ( NCT07153146 ) of PN-881, a first-in-class oral IL-17 peptide antagonist, evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult participants.

• The triple GLP/GIP/GCG agonists PN-477sc and PN-477o are progressing through IND-enabling studies with clinical study initiation of PN-477sc anticipated by mid-2026, and initiation of PN-477o anticipated in the second half of 2026.

• The Company plans to nominate a development candidate ready for IND-enabling studies from the oral hepcidin program by year end.

Third Quarter 2025 Financial Results

• Cash, Cash Equivalents and Marketable Securities : Cash, cash equivalents and marketable securities as of September 30, 2025, were $678.8 million as compared to $559.2 million as of December 31, 2024.

• License and Collaboration Revenue :

  • License and collaboration revenue was $4.7 million for both the three months ended 2025 and 2024 and was comprised of development services we provided under the Takeda collaboration agreement.

  • License and collaboration revenue of $38.6 million for the nine months ended September 30, 2025 was comprised of (i) proportional recognition of a $25 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period. License and collaboration revenue of $263.8 million for the nine months ended September 30, 2024 included (i) $254.1 million of the $300.0 million initial transaction price for the Takeda collaboration agreement allocated to the rusfertide license upon effectiveness of the agreement, and (ii) development services we provided during the period.

• Research and Development ("R&D") Expenses : Increased by $4.0 million and $9.7 million for the three and nine months ended September 30, 2025, respectively, from the prior year periods. The increases were primarily due to increases in drug discovery and pre-clinical research expenses.

• General and Administrative ("G&A") Expenses : Increased by $1.0 million for the three months ended September 30, 2025, from the prior year period primarily due to increases in professional services. The decrease of $1.1 million in G&A expenses for the nine months ended September 30, 2025, from the prior year period was primarily due to $4.6 million in one-time advisory and legal fees related to the Takeda collaboration in Q1 24, partially offset by increases in personnel-related expenses and professional services.

• Net Income (Loss) : Net loss was ($39.3) million, or ($0.62) per basic and diluted share, for the three months ended September 30, 2025, as compared to a net loss of ($33.2) million, or ($0.54) per basic and diluted share, for the three months ended September 30, 2024. Net loss was ($85.8) million, or ($1.35) per basic and diluted share, for the nine months ended September 30, 2025, as compared to net income of $143.5 million, or $2.34 per basic share and $2.22 per diluted share, for the nine months ended September 30, 2024.

About Protagonist

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with a New Drug Application (NDA) for icotrokinra submitted to the FDA in July, and the NDA submission for rusfertide expected by end of 2025. Icotrokinra (formerly, JNJ-2113), is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R"), which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for the development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and the oral hepcidin program.

More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com .

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of icotrokinra and PN-881, and expectations regarding the icotrokinra and PN-881 development programs. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.

Investor Relations Contact

Corey Davis, Ph.D.

LifeSci Advisors

cdavis@lifesciadvisors.com

+1 212 915 2577

Media Relations Contact

Virginia Amann

ENTENTE Network of Companies

virginiaamann@ententeinc.com

+1 833 500 0061 ext 1

PROTAGONIST THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

(Amounts in thousands except share and per share data)

(1) Amount includes non-cash stock-based compensation expense.

Stock-based Compensation

(Unaudited, in thousands)

PROTAGONIST THERAPEUTICS, INC.

Selected Condensed Consolidated Balance Sheet Data

(Unaudited, In thousands)

SOURCE: Protagonist Therapeutics

View the original press release on ACCESS Newswire