HUTCHMED Highlights Publication of Phase III SACHI Results in The Lancet

On January 14, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that results from the SACHI Phase III trial were published in The Lancet. SACHI is a Phase III study of the savolitinib (ORPATHYS) and osimertinib (TAGRISSO) combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ("EGFR") mutation-positive non-small cell lung cancer ("NSCLC") with MET amplification after disease progression on first-line EGFR tyrosine kinase inhibitor ("TKI") therapy.

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Savolitinib is an oral, potent and highly selective MET TKI being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. Osimertinib is a third-generation, irreversible EGFR TKI. Based on interim data from SACHI, the savolitinib and osimertinib combination was granted regulatory approval in China in June 2025.

"The SACHI trial, now published in The Lancet, provides compelling evidence that savolitinib combined with osimertinib can transform outcomes for patients with EGFR-mutated NSCLC with MET amplification. These findings highlight the combination’s ability to address MET amplification, a critical resistance mechanism, offering clinically meaningful improvements for this challenging patient population," said Professor Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and co-leading Principal Investigator of the SACHI trial, said, "We are particularly encouraged by the consistent benefits observed in patients previously treated with third-generation EGFR-TKIs, where savolitinib plus osimertinib offers a continued all-oral regimen, providing a convenient and well-tolerated solution for this underserved population." Professor Jie Wang of Cancer Hospital, Chinese Academy of Medical Sciences also served as co-leading Principal Investigator of the SACHI trial.

About the SACHI Phase III Trial

In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI considered that the study had met the pre-defined primary endpoint of progression-free survival ("PFS") in a planned interim analysis and, as a result, enrollment into the study has concluded. As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination (n=106) or chemotherapy (n=105). In the intention-to-treat ("ITT") population, the median PFS assessed by investigator was 8.2 months (95% confidence interval ["CI"] 6.9–11.2) with savolitinib plus osimertinib, compared to 4.5 months (95% CI 3.0–5.4) with chemotherapy (hazard ratio ["HR"] 0.34; 95% CI 0.23–0.49; p<0.0001). The independent review committee ("IRC") assessed median PFS was 7.2 vs 4.2 months, respectively (HR 0.40; 95% CI 0.28–0.59; p<0.0001).

The investigator-assessed objective response rate ("ORR") was 58% in the savolitinib plus osimertinib arm compared to 34% for patients in the chemotherapy arm. The disease control rate (DCR) was 89% vs 67%, and the median duration of response (DoR) was 8.4 vs 3.2 months, respectively. The median time to response (TTR) was similar between two arms (1.4 vs 1.5 months). Overall survival ("OS") data were still evolving and not mature at the time of the interim analysis, with only 37% and 43% OS maturity. At median OS follow-up duration of 17.7 months in the ITT population, savolitinib plus osimertinib arm reported median OS of 22.9 months vs 17.7 months in the chemotherapy arm (HR 0.84). 55 (52%) patients in the chemotherapy arm received subsequent MET inhibitor therapy after disease progression, with 45 (43%) crossing over to savolitinib-osimertinib and ten (10%) subsequently received MET inhibitor. In sensitivity analyses of OS to adjust for this crossover, the OS benefits of the savolitinib plus osimertinib arm were more significant, with HRs ranging from 0.24 to 0.62.

In the third-generation EGFR TKI–naïve subgroup population (i.e. patients previously treated with a first- or second-generation EGFR TKI), investigator-assessed median PFS was 9.8 vs 5.4 months (HR 0.34; 95% CI 0.21–0.56; p<0.0001). Efficacy outcomes in the third-generation EGFR-TKI–treated subgroup were comparable with those in the ITT population. In this subgroup, the investigator-assessed median PFS was 6.9 vs 3.0 months (HR 0.32; 95% CI 0.18–0.57; p<0.0001), and IRC-assessed median PFS was 6.9 vs 3.0 months (HR 0.32; 95% CI 0.18–0.58; p<0.0001).

The safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events ("TEAEs") of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib arm compared to 57% (55 of 96) for patients in the chemotherapy arm. Common Grade ≥3 TEAEs (≥10% in either arm) included decreased neutrophil count (14% vs 26%), decreased white blood cell count (7% vs 13%), and anemia (4% vs 23%).

About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2 The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated ("EGFRm") NSCLC.3,4,5,6,7

MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.8,9

About ORPATHYS

ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI 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.

ORPATHYS is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. ORPATHYS is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy, in combination with TAGRISSO.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

About TAGRISSO

TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO is also being investigated in this setting in combination with ORPATHYS (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

TAGRISSO also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

About ORPATHYS and TAGRISSO Combination Development in EGFR-mutated NSCLC

This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this setting. Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS in combination with TAGRISSO has been studied extensively in these patients in the TATTON study (NCT02143466) and the SAVANNAH single-arm Phase II study (NCT03778229). Strong data from SAVANNAH presented at the 2025 European Lung Cancer Congress (ELCC) demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The encouraging results led to the initiation of several randomized Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836).

SACHI: This Phase III trial in China evaluated the combination of ORPATHYS and TAGRISSO compared to platinum-based doublet chemotherapy for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC following progression on treatment with an EGFR TKI. Results were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. The treatment combination received approval in China in June 2025.

SAFFRON: This ongoing global Phase III trial is to evaluate the combination of ORPATHYS and TAGRISSO compared to platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO. This received Fast Track Designation from the US FDA and enrollment was completed in October 2025. We look forward to completing this trial to support potential US and other global registration filings.

SANOVO: This ongoing Phase III trial in China is to evaluate the combination of ORPATHYS and TAGRISSO compared to TAGRISSO monotherapy in previously untreated patients with locally advanced or metastatic NSCLC with EGFRm and MET overexpression. Enrollment was completed in August 2025.

(Press release, Hutchison China MediTech, JAN 14, 2026, View Source [SID1234662040])

C4 Therapeutics Outlines Strategic Milestones to Advance Cemsidomide as a Potential Best-in-Class IKZF1/3 Degrader and Discovery Strategy Focused on Novel Targets in Clinically Validated Pathways

On January 14, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported milestones through 2028 and highlighted recent achievements.

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"We begin 2026 with compelling opportunities ahead, anchored by cemsidomide’s path to become a foundational medicine for multiple myeloma by reaching patients across multiple lines of therapy. As we prepare to initiate two cemsidomide trials in the coming months, we believe the emerging data exploring the class in combination with BiTE therapies derisks our strategy to rapidly advance cemsidomide through registrational development," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "We are equally excited about our new discovery strategy that leverages a decade of learnings in the TPD field as well as the strengths of our platform to address unmet needs for inflammation, neuro-inflammation and neuro-degenerative diseases by degrading novel targets that modulate validated inflammatory pathways. Our strong balance sheet provides cash runway through key inflection points, keeping us positioned to advance our portfolio and create transformative medicines for patients."

Anticipated Key Strategic Milestones
C4T’s vision is to become a fully integrated biopharmaceutical company leveraging the benefits of targeted protein degradation across drug discovery, clinical development and commercialization to create and deliver breakthrough therapies for patients. To achieve this vision, C4T’s strategy centers around rapidly advancing cemsidomide to become the IKZF1/3 degrader of choice across lines of therapy and progressing its early portfolio of high-value degraders pursuing novel targets. The following anticipated key strategic milestones through 2028 support this strategy.

Cemsidomide
Relapsed/Refractory Multiple Myeloma: Fourth Line or Later

In Q1 2026, initiate the Phase 2 MOMENTUM trial of cemsidomide and dexamethasone and complete enrollment within 12 months.
In mid-2026, present further analysis of the data from the ongoing Phase 1 trial of cemsidomide and dexamethasone.
In 2H 2027, present initial overall response rate (ORR) data for the MOMENTUM trial.
In mid-2028, present efficacy and safety for the MOMENTUM trial.
By year-end 2028, submit new drug application evaluating cemsidomide and dexamethasone for potential accelerated approval in fourth line or later.
Relapsed/Refractory Multiple Myeloma: Second Line or Later

In Q2 2026, initiate the Phase 1b trial of cemsidomide in combination with elranatamab and provide incremental updates throughout dose escalation.
In mid-2026, share the plan to initiate an additional Phase 1b trial to evaluate cemsidomide in combination with other anti-myeloma agents.
In mid-2027, present Phase 1b data from all cohorts evaluating cemsidomide in combination with elranatamab.
By early 2028, initiate the Phase 3 trial evaluating cemsidomide in combination with a BCMA BiTE.
Early Portfolio: CFT8919

In Q1 2026, utilize data from the Phase 1 dose escalation trial to inform ex-China clinical development.
Early Portfolio: Internal Discovery Projects Focused on Inflammation, Neuro-inflammation and Neuro-degenerative Diseases

By year-end 2028, deliver up to three investigational new drug applications.
Early Portfolio: Discovery Collaborations

Earn additional research milestones and potential licensing fees from collaborations with Merck KGaA, Darmstadt, Germany, Roche and Biogen.
By year-end 2026, deliver at least one development candidate to a collaboration partner.
By year-end 2026, advance existing collaborations toward key milestones.
2025 Achievements
Cemsidomide

Completed enrollment in the Phase 1 trial of cemsidomide and dexamethasone and presented data demonstrating that the two highest dose levels (75 µg and 100 µg) achieved a 40% and 53% ORR, respectively. This compelling anti-myeloma activity in a heavily pretreated patient population reinforces cemsidomide’s potential best-in-class profile.
Developed a regulatory path incorporating FDA feedback that positions cemsidomide to potentially receive two distinct accelerated approvals in (1) fourth line or later for cemsidomide and dexamethasone, and (2) second line or later for cemsidomide in combination with a BCMA BiTE.
Selected 100 µg dose for the MOMENTUM trial as the recommended Phase 2 dose after discussions with FDA.
CFT8919

Advanced the Phase 1 dose escalation trial in China with partner Betta Pharmaceuticals to generate data that will inform C4T’s next steps.
Internal Discovery Pipeline

Implemented new discovery strategy focused on developing degrader medicines for five novel targets that modulate three clinically validated pathways for inflammation, neuro-inflammation and neuro-degenerative diseases to potentially deliver new therapies with enhanced efficacy for patients with unmet needs. This strategy leverages C4T’s expertise in developing highly catalytic orally bioavailable degraders that penetrate the blood brain barrier to achieve high central nervous system exposures and compelling efficacy in central nervous system models as well as C4T’s ability to control targeted protein levels through finely tuned degrader kinetics.
Extended capabilities to identify molecular glue degraders for targets with and without G- and RT-loops by utilizing DNA-encoded library (DEL) technology.
About Cemsidomide
Cemsidomide is an investigational, orally bioavailable molecular glue degrader of IKZF1/3, transcription factors that drive multiple myeloma. Data from the Phase 1 trial, which has completed enrollment, show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that support the potential for durable outcomes.

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).

About Cemsidomide in Combination With Elranatamab (ELREXFIO)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).

About Multiple Myeloma
Multiple myeloma (MM) is a rare blood cancer affecting plasma cells. Approximately 36,000 people in the United States are diagnosed with MM each year. Despite advances in treatment, MM remains incurable. Treatment combinations include IKZF1/3 degraders, which are established backbone therapies, across lines of therapy.

(Press release, C4 Therapeutics, JAN 14, 2026, View Source [SID1234662035])

BriaCell Therapeutics Announces Pricing of $30 million Public Offering

On January 13, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the pricing of a best-efforts public offering of 5,366,726 units. Each unit consists of one common share (or pre-funded warrant ("Pre-Funded Warrant") in lieu thereof) and one warrant (the "Warrants"). Each unit is being sold to the public at a price of $5.59 per unit (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of approximately $30 million, before deducting placement agent fees and offering expenses. The Warrants included in the units have been approved for listing on the Nasdaq Capital Market and are expected to commence trading under the symbol "BCTXL" on January 14, 2026. Each Warrant is immediately exercisable, will entitle the holder to purchase one common share at an exercise price of $6.93 per share and will expire five years from the date of issuance. The common shares (or Pre-Funded Warrants) and Warrants can only be purchased together in the offering but will be issued separately.

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The offering is expected to close on January 15, 2026, subject to satisfaction of customary closing conditions. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

The Company intends to use the net proceeds from the offering to fund working capital requirements, general corporate purposes and the advancement of the Company’s business objectives.

ThinkEquity is acting as the sole placement agent for the offering.

A registration statement on Form S-1 (File No. 333-292388) relating to the securities was filed with the Securities and Exchange Commission ("SEC") on December 23, 2025, and became effective on January 13, 2026, and a related registration statement was filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, on January 13, 2026. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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 jurisdiction.

(Press release, BriaCell Therapeutics, JAN 13, 2026, View Source [SID1234662206])

BriaCell Reports Sustained Complete Resolution of Lung Metastasis in Bria-OTS(TM) Patient

On January 13, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the durable and sustained complete resolution of a lung metastasis in a patient with metastatic breast cancer (MBC) treated with Bria-OTS, BriaCell’s personalized off the shelf immunotherapy. The patient is hormone receptor-positive (HR+), HER2-negative.

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The first patient enrolled in the Bria-OTS study, a 78-year-old woman with advanced metastatic breast cancer and multiple prior treatment failures, achieved complete (100%) resolution of a lung metastasis following four doses of Bria-OTS single agent therapy. The complete response, initially observed at 2 months (previously reported), was subsequently confirmed at 4 months (previously reported), 6 months (previously reported), and now at 11 months. The patient received 17 cycles of Bria-OTS, completed 12 months of the study, and remains in survival follow-up.

The Phase 1 dose escalation portion of the study is complete and the Phase 2a portion, evaluating combination of Bria-OTS with an immune checkpoint inhibitor, is now underway.

"The sustained clinical response observed in this late-stage MBC patient, who had previously progressed through multiple prior treatments is remarkable," stated Neal S. Chawla MD, Director at the Sarcoma Oncology Center, Santa Monica, CA, and Principal Investigator for the Bria-OTS study. "We are excited to further evaluate Bria-OTS in combination with an immune checkpoint inhibitor in metastatic breast cancer."

"These clinical findings reinforce our confidence in the therapeutic potential and safety of the Bria-OTS platform," added Dr. William V. Williams, BriaCell’s President and CEO. "Our team remains committed to advancing our novel therapeutic approach with the goal of making a meaningful difference for patients with metastatic breast cancer, particularly those with limited treatment options."

About Bria-OTS

Bria-OTS is a next generation, off-the-shelf personalized immunotherapy based on BriaCell’s lead candidate Bria-IMT currently being evaluated in a Phase 1/2a study (ClinicalTrials.gov identifier: NCT06471673) in patients with metastatic recurrent breast cancer. The trial includes both monotherapy dose escalation and checkpoint inhibitor combination dose expansion cohorts. The Company has recently entered the dose expansion phase.

(Press release, BriaCell Therapeutics, JAN 13, 2026, View Source [SID1234662205])

Vivere Oncotherapies Announces >$10M Funding to Develop Targeted Therapies for Solid Tumors

On January 13, 2026 Vivere Oncotherapies, a UC Berkeley spin-out developing cancer therapies that activate the immune system to detect and destroy cancer cells in immunologically cold tumors, reported over $10M in funding from YK Bioventures, Pillar, Berkeley Frontier Fund, Freeflow Ventures and The National Cancer Institute. Leveraging technology that enables engineering of targeted immunotherapies, Vivere will develop transformative treatments for difficult-to-treat cancers that otherwise evade immune system detection and for which there are few effective treatments.

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Solid tumors such as colorectal and ovarian are among the most difficult cancers to treat. These tumors are characterized by their lack of immune-cell infiltration, making them resistant to conventional immunotherapies like checkpoint inhibitors. Despite decades of research, there has been limited success in cracking the code on cold tumors, leaving patients with few options and poor prognosis.

"Vivere’s goal is to empower the patients’ immune systems to fight off cancer. Our team is united by a belief that cold tumors are not inherently untreatable, just misunderstood," said Melissa Kotterman, Ph.D., CEO of Vivere Oncotherapies. "We’ve spent years building a platform capable of breaking through the immunological invisibility of these tumors. With the support of our investors, we’re now poised to bring a new generation of targeted immunotherapies to patients who currently have no effective options."

"Building Vivere’s platform has been about rethinking what’s possible in cancer therapy. From its early days, the vision was to build a platform that could finally unmask cold tumors to the immune system through improved delivery of targeted and safe therapies," said David Schaffer, Ph.D., Co-founder of Vivere Oncotherapies and Professor of Chemical and Biomolecular Engineering, Bioengineering, and Molecular and Cell Biology at UC Berkeley and Director of QB3 and Bakar Labs. "Our team’s rare combination of engineering, immunology, and translational expertise paired with our experience in building clinical-stage biotech companies gives us the tools to tackle problems others have deemed intractable."

(Press release, Vivere Oncotherapies, JAN 13, 2026, View Source [SID1234662034])