On November 28, 2025 A new collaborative study from Pusan National University and Yonsei University reported that the FOLFIRINOX regimen showed numerically improved survival outcomes compared to current standards such as FOLFOX, FOLFIRI, and nal-IRI/FL, while maintaining manageable toxicity levels. These findings suggest that FOLFIRINOX could serve as a promising second-line treatment option for patients with advanced BTC following first-line chemotherapy failure, warranting further validation through prospective clinical studies.

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Researchers determined FOLFIRINOX may extend survival in advanced biliary tract cancer as a second-line therapy with manageable toxicity
Researchers determined FOLFIRINOX may extend survival in advanced biliary tract cancer as a second-line therapy with manageable toxicity
Biliary tract cancers, including intrahepatic, perihilar, and extrahepatic cholangiocarcinoma and gallbladder cancer, are among the most aggressive gastrointestinal malignancies. Treatment options remain limited once the disease progresses, after first-line chemotherapy, and survival rarely exceeds one year.

To address this, the team of researchers led by Professor Yun Hak Kim from Pusan National University analyzed 12 years of clinical data from 54 patients treated at Yonsei Severance Hospital and combined the results with a systematic review and meta-analysis of 21 studies from around the world. This paper was made available online on 05 September 2025 in the journal International Journal of Surgery.

The combined evidence suggests that FOLFIRINOX may provide better progression-free and overall survival than currently recommended regimens such as FOLFOX, FOLFIRI, or nal-IRI/FL.

"We conducted a meta-analysis integrating 12 years of real-world data on the use of FOLFIRINOX or mFOLFIRINOX as salvage treatment in patients with advanced BTC treated at the Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, along with all available published studies on second-line chemotherapy regimens for advanced BTC," said Prof. Kim.

In this study, patients receiving FOLFIRINOX achieved a median progression-free survival of 4.2 months and an overall survival of 11.4 months. In the accompanying meta-analysis of 21 studies, FOLFIRINOX demonstrated numerically longer progression-free and overall survival compared with currently used second-line regimens such as FOLFOX, FOLFIRI, and nal-IRI/FL.

Still, the authors caution that toxicity remains significant. Nearly 40 percent of patients developed severe neutropenia, requiring dose adjustments or additional medical support. The team emphasizes that FOLFIRINOX should be reserved for fit patients under close supervision until further prospective trials confirm its broader safety.

Beyond short-term survival, the study highlights the potential to integrate biomarker-based selection and supportive strategies such as granulocyte colony-stimulating factor to mitigate toxicity. Future research may also explore pairing FOLFIRINOX with immunotherapies or molecular-targeted drugs. "Our findings suggest that FOLFIRINOX may offer a potential benefit as a second-line treatment option for BTC following progression on first-line chemotherapy," concluded Prof. Kim.

This paper provides an evidence-based foundation for clinicians considering treatment options after first-line chemotherapy failure and may guide updates to future BTC management guidelines.

(Press release, Pusan National University, NOV 28, 2025, View Source [SID1234660998])

On November 28, 2025 Pasithea Therapeutics Corp. ("Pasithea" or the "Company") (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), reported the pricing of a public offering of 80,000,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.75 per share of common stock (or per pre-funded warrant in lieu thereof). The public offering was led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The closing of the offering is expected to occur on or about December 1, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $60 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes. The Company’s cash position following the closing will extend its cash runway through at least the first half of 2028. Such corporate purposes include, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-291611) originally filed with the Securities and Exchange Commission ("SEC") on November 18, 2025, as amended on November 26, 2025, and declared effective on November 28, 2025. The offering is being made only by means of a prospectus, which is part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

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

(Press release, Pasithea Therapeutics, NOV 28, 2025, View Source [SID1234660995])

On November 27, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported 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) (Free ASH Whitepaper) ("ASH") Annual Meeting taking place on December 6-9, 2025 in Orlando, USA.

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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 (Free ESMO Whitepaper) 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:

Abstract title Presenter/Lead author Presentation details
ESMO Asia Congress 2025 – SPONSORED STUDIES
A first-in-human (FIH), dose escalation study of HMPL-A83 (A83), an anti-CD47 monoclonal antibody (mAb) in patients (pts) with advanced solid tumors
Ye Guo
(Shanghai, China) 162MO | Mini Oral session: Developmental therapeutics and precision medicine
Sunday, December 7, 2025
11:40 – 11:45 SGT
Hall 407
Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): results from phase 2 part of FRUSICA-2 Shanshan Wang
(Shanghai, China) 540O | Proffered Paper session: Genitourinary tumours
Friday, December 5, 2025
14:55 – 15:05 SGT
Hall 402
Surufatinib (S) in combination with camrelizumab (C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in metastatic pancreatic cancer: results from phase 2 part of a randomized, open-label, active-controlled, phase 2/3 study Shukui Qin
(Nanjing, China) 375P | Poster Display: Gastrointestinal tumours, non‑colorectal
Osimertinib (osi) + savolitinib (savo) in EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) with MET overexpression and/or amplification (OverExp/Amp) following progressive disease (PD) on osi: SAVANNAH Asian subset Se-Hoon Lee
(Seoul, Korea) 982P | Poster Display:
Thoracic tumours, metastatic
Patient-relevant Outcomes (PROs) from SACHI: a Phase 3 Trial of Savolitinib (Savo) plus Osimertinib (Osi) versus Chemotherapy (Chemo) in EGFR-mutant (EGFRm) and MET-amplified (METamp) Advanced NSCLC after Progression on EGFR-TKIs Yongfeng Yu
(Shanghai, China) 984P | Poster Display:
Thoracic tumours, metastatic
Analysis of MET Amplification (METamp) with FISH and NGS Method in SACHI Trial Longhua Sun
(Nanchang, China) 988P | Poster Display:
Thoracic tumours, metastatic
Progression pattern in patients (pts) with EGFR-mutant (EGFRm), MET-amplified (METamp) advanced NSCLC treated with savolitinib (savo) plus osimertinib (osi) Haiyan Yang
(Changsha, China) 1002P | Poster Display:
Thoracic tumours, metastatic
MET testing and treatment (tx) sequencing after progression of disease (PD) on first-line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): Final analysis of a global real-world (rw) study Julia Rotow
(Boston, US) 1005P | Poster Display:
Thoracic tumours, metastatic
ESMO Asia Congress 2025 – INVESTIGATOR-INITIATED STUDIES
Fruquintinib Combined with TAS-102 with or without SBRT as Third- or Later-Line Treatment in Metastatic Colorectal Cancer: Preliminary Results from a Prospective Phase II Trial Chen Zhang/ Yi Wang
(Ningbo, China) 205P | Poster Display: Gastrointestinal tumours, colorectal
Efficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide arm Guanghai Dai/ Miaomiao Gou
(Beijing, China) 245eP | Poster Display: Gastrointestinal tumours, colorectal
The Efficacy and Safety of Fruquintinib (F) Plus FOLFIRI as Second-line (2L) Treatment in Bevacizumab (Bev)-pretreated RAS-mutated (RAS‑m) Metastatic Colorectal Cancer (mCRC) Zhenyang Liu/ Xiaolin Yang
(Changsha, China) 250eP | Poster Display: Gastrointestinal tumours, colorectal
Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer Xiujuan Qu/ Lin Xu
(Shenyang, China) 255eP | Poster Display: Gastrointestinal tumours, colorectal
Matching-Adjusted Indirect Comparison of Surufatinib versus High-Dose Octreotide LAR in Advanced Extrapancreatic Neuroendocrine Tumors Jianming Xu
(Beijing, China) 214P | Poster Display: Gastrointestinal tumours, colorectal
Efficacy and safety of surufatinib in combination with CAPTEM as conversion therapy in patients with unresectable pancreatic neuroendocrine tumors (pNETs): Data updates from a prospective, open-label study Xubao Liu/ Ziyao Wang
(Chengdu, China) 400P | Poster Display: Gastrointestinal tumours, non‑colorectal

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 (Free ASH Whitepaper) Annual Meeting. Details of the presentation is as follows:

Abstract title Presenter/Lead author Presentation details
2025 ASH (Free ASH Whitepaper) Annual Meeting – SPONSORED STUDIES
Phase 3 ESLIM-01 study: Final analysis of efficacy and safety of long-term treatment with sovleplenib in adults with chronic primary immune thrombocytopenia
Renchi Yang (Tianjin, China) 843 | Oral Abstract Session
Monday, December 8, 2025
15:15 – 15:30 EST
Room OCCC – W304EFGH

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.

(Press release, Hutchison China MediTech, NOV 27, 2025, View Source [SID1234660989])

On November 27, 2025 Imugene Ltd (ASX:IMU), a clinical-stage immuno-oncology company, and JW Therapeutics (Shanghai) Co., LTD (HKEX:2126), a leading biotechnology company focused on cell-based immunotherapies, reported a co-development collaboration to evaluate the combination of Imugene’s oncolytic virus CF33-CD19 (onCARlytics) and JW’s Carteyva—a CD19- directed autologous CAR-T cell therapy—for patients with advanced solid tumors.

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This collaboration includes preclinical in vitro and in vivo studies, followed by a Phase 1 investigator-initiated trial to be conducted exclusively in China at premier CAR-T clinical centers. The approach utilizes Imugene’s CF33-CD19 virus to induce CD19 expression on tumor cells, rendering them susceptible to targeting by CD19 CAR-T therapies—a transformative "mark and kill" strategy.

"This collaboration allows us to validate our onCARlytics platform in combination with an approved autologous CAR-T product," said Leslie Chong, Managing Director and CEO of Imugene. "We believe Carteyva which is already approved in blood cancer is an ideal choice, and this initiative enables us to generate impactful data efficiently while exploring a breakthrough treatment paradigm for solid tumours."

With clear go/no-go decision points, and milestones, the collaboration ensures disciplined capital allocation while enabling strategic flexibility.

(Press release, Imugene, NOV 27, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/2f4974d7-399e-d9a4-0ddd-55588cedec81/Strategic_Collaboration_with_JW_Therapeutics.pdf [SID1234660990])

On November 27, 2025 GC Genome, a leading clinical genomics and liquid biopsy company, reported that its collaborative study with Professor Byeon, Jeong-Sik’s team at Asan Medical Center has been published in The American Journal of Gastroenterology(AJG).

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GC Genome applied its proprietary AI-based fragmentomics technology, used in its MCED test, ai-CANCERCH. This study demonstrates the potential for a convenient, alternative to colonoscopy and fecal based screening methods, while enabling early detection of colorectal cancer and advanced adenomas.

Study Overview

A total of 1,677 individuals were enrolled, including: 302 with CRC, 108 with AA
1,267 with normal colonoscopy as healthy or non-cancer controls
The test analyzes cfDNA fragmentomic signatures using low-coverage whole-genome sequencing (Lc-WGS) combined with a proprietary AI algorithm, enabling highly sensitive detection of early-stage disease.

Key Findings

CRC sensitivity: 90.4%
Specificity in individuals with normal colonoscopy: 94.7%
Sensitivities by CRC stage : 84.2% (stage I), 85.0% (stage II), 94.4% (stage III), and 100.0% (stage IV)
Sensitivity for T1N0 lesions (eligible for endoscopic resection): 90.0%
Sensitivity for AA: 58.3%
The results remained consistent regardless of: CRC locations (left vs. right colon), age of CRC patients(<60 vs. ≥60), and AA locations

These findings highlight the test’s potential as a reliable cfDNA-based blood test for CRC screening and early prevention.

A GC Genome spokes person stated "Detecting colorectal cancer together with precancerous lesions represents a meaningful advance in prevention. With our fragmentomics technology now validated through publication in a leading gastroenterology journal, GC Genome will continue expanding global clinical collaborations and screening applications."

(Press release, GC Genome, NOV 27, 2025, View Source [SID1234660991])