RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China), Innovative Licensing and Access Pathway (United Kingdom)

Structure/Sequence

Sequence Code 616714836H

Source: *****

Sequence Code 616714851L

Source: *****

Clinical Trials associated with Sugemalimab

NCT05700448

/ Not yet recruitingPhase 3

A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

Start Date01 Jun 2026

Sponsor / Collaborator

CStone Pharmaceuticals Co. Ltd.

NCT06987734

/ RecruitingPhase 2IIT

Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients

This is a single arm, open-label exploratory study conducted in resectable stage II-IIIA NSCLC without EGFR/ALK mutations, aiming to investigate feasibility, safety and efficacy of Sugemalimab in perioperative contexts. Twenty-five resectable stage II-IIIA patients are planned to be enrolled. The proportion of patients with squamous cell carcinoma will not less than 40%.
Combined neoadjuvant chemotherapy and immunotherapy with fixed dose of Sugemalimab 1200 mg IV Q3W + Platinum-based chemo in resectable stage II-IIIA NSCLC adult patients followed by surgery. After completion of neoadjuvant therapy (3-4 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression in neoadjuvant therapy. Pathological response is planned to assessed after surgery. Following surgery, the patients with complete resection will receive an additional 1 year of Sugemalimab q3w. Treatment will commence as soon as clinically feasible post-surgery.
Informed consent will be obtained prior to tissue collection and genome sequencing for each participant. Primary tumour tissue will be obtained at diagnosis by biopsy such as percutaneous lung puncture biopsy, bronchoscopic biopsy or endobronchial ultrasound (EBUS) (based on clinical practice). Fresh tumour tissue was collected after surgical resection. Tissues collected were subjected to medically necessary pathology for diagnosis. Specimens were processed for multiplex immunofluorescence, single-cell sequencing and spatial transcriptomics, bulk RNAseq and WES to explore the changes in the immune microenvironment before and after suglizumab administration.

Start Date19 Jun 2025

Sponsor / Collaborator

Shanghai Pulmonary Hospital

[+1]

CTR20233170

/ RecruitingPhase 1

活菌MNC-168肠溶胶囊分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的安全性、耐受性、药代动力学特征及初步有效性的I期临床研究

[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of live bacteria MNC-168 enteric-coated capsules combined with pembrolizumab and sugemalimab in subjects with advanced malignant solid tumors

主要目的：评价MNC-168分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的安全性和耐受性，确定其最大耐受剂量（MTD）和/或推荐的II期剂量(RP2D)。次要目的： 1) 评价MNC-168分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的药代动力学特征； 2) 评估MNC-168分别联用帕博利珠单抗、舒格利单抗的初步抗肿瘤疗效，为后续临床研究推荐合适的用药剂量。

[Translation]

Primary objective: To evaluate the safety and tolerability of MNC-168 in combination with pembrolizumab and sugemalimab in subjects with advanced malignant solid tumors, and to determine its maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D). Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of MNC-168 in combination with pembrolizumab and sugemalimab in subjects with advanced malignant solid tumors; 2) To evaluate the preliminary anti-tumor efficacy of MNC-168 in combination with pembrolizumab and sugemalimab, and to recommend appropriate dosages for subsequent clinical studies.

Start Date24 Sep 2024

Sponsor / Collaborator

Guangzhou Colony Biotechnology Co., Ltd.

100 Clinical Results associated with Sugemalimab

100 Translational Medicine associated with Sugemalimab

100 Patents (Medical) associated with Sugemalimab

Literatures (Medical) associated with Sugemalimab

31 Dec 2026·Human Vaccines & Immunotherapeutics

Cost-effectiveness analysis of sugemalimab plus chemotherapy for the first-line treatment of advanced gastric cancer or gastroesophageal junction cancer

Article

Author: Yan, Chunyan ; Lv, Guoguang ; Li, Jiayan ; Diao, Ruigang ; Gao, Yuan ; He, Jing

The GEMSTONE-303 trial demonstrated the significant efficacy and safety of sugemalimab plus chemotherapy (S + C) as first-line treatment for patients with advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJC). To evaluate the cost-effectiveness of S + C for advanced GC/GEJC from the perspective of the Chinese healthcare system. A partitioned survival model with a 3-week cycle was created to evaluate the cost-effectiveness of S + C compared to placebo plus chemotherapy (P + C) as the first-line treatment for advanced GC/GEJC. Total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) as the primary outputs. Sensitivity analyses were performed to evaluate the uncertainty and stability of model parameters. Additionally, subgroup and scenario analyses were conducted. The base-case analysis revealed that the total costs of S + C ($89,510.52) was $49,907.43 higher than that P + C ($39,603.10). However, it also increased the QALYs by 0.29 (1.27 QALYs vs. 0.98 QALYs), with an ICER of $170,440.21/QALY, which was higher than the willingness-to-pay of $40,334.05/QALY. Sensitivity analyses demonstrated that the cost of sugemalimab, utility of progression-free survival and the discount rate had a greater impact on the model. Subgroup analyses indicated that S + C was more cost-effective in patients with advanced GC/GEJC with programmed cell death ligand 1 combined positive score ≥10. Compared to P + C, S + C is currently not an economically viable option for first-line treatment of advanced GC/GEJC in China.

31 Dec 2025·ANNALS OF MEDICINE

Cost-effectiveness of sugemalimab plus chemotherapy as first-line therapy in advanced gastric cancer and gastroesophageal junction cancer.

Article

Author: Xu, Qiaoping ; Li, Zhengxiong ; Zhu, Jiaming

BACKGROUND:

The GEMSTONE-303 trial demonstrated that sugemalimab combined with capecitabine and oxaliplatin (CAPOX) improved survival benefit in patients with advanced gastric/gastroesophageal junction cancer (GC/GEJC) and a programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥5. However, its cost-effectiveness in China remains unassessed.

METHODS:

A partitioned survival model was developed from the Chinese healthcare payer perspective using data from the GEMSTONE-303 trial. Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were evaluated over a 10-year horizon. Sensitivity analyses assessed model uncertainty, while subgroup and scenario analyses examined the impact of PD-L1 expression, drug pricing, and patient assistance programs (PAPs).

RESULTS:

In the PD-L1 CPS ≥ 5 group, sugemalimab plus CAPOX yielded an incremental cost of $44,455.46 and 0.22 additional QALYs compared to chemotherapy, resulting in an ICER of $206,024.50/QALY. For patients with CPS ≥10, the ICER dropped to $173,182.90/QALY, but still exceeded the willingness-to-pay (WTP) threshold. One-way sensitivity analysis revealed sugemalimab price as the most influential parameter, requiring a 75.6% price reduction to achieve cost-effectiveness. A PAP reduced ICERs to $44,926.00/QALY and $39,513.96/QALY in the CPS ≥5 and CPS ≥10 subgroups, respectively.

CONCLUSION:

At current prices, sugemalimab plus CAPOX is not cost-effective as a first-line treatment for advanced GC/GEJC in China. It is essential to adopt a combination of targeted patient selection, price negotiation, and broader PAP access to bring the ICER below the WTP threshold. These findings inform reimbursement negotiations and highlight the need for stratified pricing strategies to optimize accessibility in economically diverse populations.

01 Sep 2025·Therapeutic Advances in Gastroenterology

Cost-effectiveness analysis of Cadonilimab in first-line treatment of advanced HER2-negative gastric cancer or gastroesophageal junction cancer

Article

Author: Pan, Zhaoyi ; Zhu, Kaiqi ; Huang, Jin ; Qin, Mengyao

Background::

Immune checkpoint inhibitors (ICIs), including Pembrolizumab, Nivolumab, Sintilimab, Tislelizumab, and Sugemalimab, have been approved in China as first-line treatments for advanced HER2-negative gastric cancer (GC) and gastroesophageal junction cancer (GEJC). However, the latest COMPASSION 15 study showed that Cadonilimab in combination with chemotherapy provided significant survival benefits.

Objective::

This study aims to evaluate the cost-effectiveness of Cadonilimab plus chemotherapy versus chemotherapy alone and the ICIs approved in China for first-line treatment of advanced HER2-negative gastric cancer or gastroesophageal junction carcinoma (GC/GEJC) from the perspective of Chinese payers.

Design::

The cost-effectiveness analysis.

Methods::

Based on the research data from COMPASSION-15, KEYNOTE-859, CheckMate-649, ORIENT-16, RATIONALE-305, and GEMSTONE-303, we constructed a 15-year Markov model to evaluate the cost and health outcomes of Cadonilimab combined with chemotherapy versus chemotherapy alone and other ICIs in advanced HER2-negative GC and GEJC. This evaluation includes total cost, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).

Results::

Cadonilimab produced 0.73 QALYs (1.10 LYs) at a cost of $26,591. It required an additional investment of $17,826 to gain 0.25 QALYs (0.37 LYs), resulting in an ICER of $72,492.29 per QALY compared to chemotherapy alone. In comparison, other ICIs approved in China—Pembrolizumab, Nivolumab, Sintilimab, Tislelizumab, and Sugemalimab—incurred total costs of $11,735, $13,970, $16,346, $10,765, and $14,857, respectively, generating 0.68 QALYs (1.04 LYs), 0.69 QALYs (1.04 LYs), 0.73 QALYs (1.12 LYs), 0.82 QALYs (1.26 LYs), and 0.81 QALYs (1.25 LYs). Sensitivity analysis revealed that the cost of Cadonilimab, the utility value of progressive disease, and the risk of platelet decline in the Cadonilimab group were the most influential factors affecting the model’s stability. At a willingness-to-pay threshold of $37,386, Cadonilimab is not a cost-effective option for the first-line treatment of advanced GE/GEJC.

Conclusion::

Cadonilimab is not a cost-effective option for the first-line treatment of advanced HER2-negative GC/GEJC. In comparison to other ICIs approved in China, Tislelizumab appears to be a more favorable option.

News (Medical) associated with Sugemalimab

11 Dec 2025

·www.prnewswire.com

Platform Technologies Drive $211B Surge in Precision Cancer Treatment

Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC, Dec. 11, 2025 /PRNewswire/ -- Equity Insider News Commentary – November's wave of FDA oncology approvals signals the industry's shift toward platform-based precision therapies over broad-spectrum approaches[1]. The global anticancer drug market now values immunotherapies at over 45% of total cancer drug revenues, reflecting investor confidence in technologies that engineer specific biological outcomes[2]. Companies deploying proprietary platforms to target previously undruggable proteins are capturing premium valuations as the sector pivots toward modularity and rapid reuse of validated mechanisms, creating momentum for GT Biopharma, Inc. (NASDAQ: GTBP), Erasca, Inc. (NASDAQ: ERAS), Foghorn Therapeutics Inc. (NASDAQ: FHTX), OmniAb, Inc. (NASDAQ: OABI), and Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX). The U.S. oncology market is projected to surge from $81 billion in 2025 to $212 billion by 2034, with monoclonal antibodies and cell therapies leading growth at double-digit rates[3]. Platform technologies now account for 60% of total pharma projected pipeline value, creating optimal conditions for companies with validated platforms to capture multiple therapeutic opportunities while reducing development timelines[4]. GT Biopharma, Inc. (NASDAQ: GTBP), a clinical-stage immuno-oncology company, recently reported continued progress with its Phase 1 clinical trial of GTB-3650, which has now advanced into Cohort 4 at a dose level of 10μg/kg/day. The company is developing innovative immunotherapy treatments designed to combat some of the world's most challenging cancer types using its proprietary natural killer cell engager TriKE platform technology. The Phase 1 dose escalation study is evaluating GTB-3650 in patients battling relapsed or refractory blood cancers that express the CD33 protein, specifically acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These represent some of the most difficult cancer cases to treat, involving patients whose disease either came back after initial therapy or never responded to conventional treatment options. GTB-3650 works by stimulating the patient's natural killer cells, a type of immune cell that naturally hunts down and destroys abnormal cells, to specifically target cancer cells. Patients receive the therapy through continuous infusions following a structured schedule: two weeks of treatment followed by two weeks of rest, repeating this cycle for up to four months based on how they respond. "We are highly encouraged by the continued progress of our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which has now advanced to Cohort 4 at a dose level of 10 µg/kg/day," said Michael Breen, Executive Chairman and CEO. "We look forward to assessing higher doses, as we are now approaching the efficacy range predicted by preclinical in vivo leukemia models, and we plan to share the next trial update in the first quarter of 2026." The six patients enrolled across Cohorts 1 through 3 have all been successfully treated with GTB-3650, demonstrating the therapy's tolerability at progressively higher dose levels. According to the company, the Cohort 4 dose level of 10μg/kg/day is more reflective of the potential clinical efficacy threshold based on positive trends observed across multiple immunological biomarkers and the complete absence of dose-limiting toxicities throughout all three completed cohorts. The Phase 1 first in human trial design calls for testing GTB-3650 in approximately 14 patients across seven cohorts, with two patients per cohort receiving progressively higher doses from 1.25μg/kg/day in Cohort 1 up to 100μg/kg/day in Cohort 7 if necessary. Beyond Cohort 4, three additional higher-dose cohorts remain available: Cohort 5 at 25μg/kg/day, Cohort 6 at 50μg/kg/day, and Cohort 7 at the maximum planned dose of 100μg/kg/day. The company plans to provide the next trial update in the first quarter of 2026. Beyond blood cancers, GT Biopharma is developing GTB-5550, which targets B7H3, a protein commonly found across various solid tumor types including breast, lung, ovarian, pancreatic, bladder, and prostate cancers. The company expects to submit its regulatory application to begin human trials of GTB-5550 in late December 2025 or January 2026. Both candidates utilize GT Biopharma's proprietary TriKE platform technology, which employs specialized antibody fragments originally found in camels and llamas. These molecules offer advantages over conventional antibodies due to their smaller size and greater stability. The company holds an exclusive worldwide license from the University of Minnesota for this technology. CONTINUED… Read this and more news for GT Biopharma, Inc. at: Erasca, Inc. (NASDAQ: ERAS) secured U.S. patent protection through 2043 for ERAS-0015, its potential best-in-class pan-RAS molecular glue, while strengthening scientific leadership with the promotion of Robert Shoemaker, Ph.D., to chief scientific officer. The clinical-stage precision oncology company reported $362 million in cash, cash equivalents, and marketable securities as of September 30, 2025, providing a runway into the second half of 2028. "Clinical development of ERAS-0015 and our potential best-in-class pan-KRAS inhibitor ERAS-4001 is on track, with initial Phase 1 monotherapy data for both ERAS-0015 and ERAS-4001 expected in 2026," said Jonathan E. Lim, M.D., CEO of Erasca. "With a strong balance sheet and a cash runway into the second half of 2028, we are well-positioned to drive our programs forward and deliver new therapeutic options with the potential to address high unmet needs of patients with RAS-driven cancers." The company's RAS-targeting franchise continues advancing toward multiple clinical milestones, with both ERAS-0015 and ERAS-4001 progressing through Phase 1 trials in patients with RAS/KRAS-mutant solid tumors. Erasca reported a net loss of $30.6 million for the third quarter ended September 30, 2025, compared to $31.2 million in the prior year period. Foghorn Therapeutics Inc. (NASDAQ: FHTX) advanced its wholly-owned selective degrader portfolio with its Selective CBP degrader entering non-GLP toxicology studies in Q4 2025 and progressing toward IND-readiness in 2026 for potential treatment of EP300-mutant cancers and ER+ breast cancer. "Momentum is strong for our wholly-owned, first-in-class selective degrader programs targeting CBP, EP300 and ARID1B with program updates highlighted during our recent virtual investor event," said Adrian Gottschalk, CEO of Foghorn. "Our Selective CBP degrader, with potential in ER+ breast cancer, entered non-GLP toxicology studies in Q4 2025 and is advancing towards IND in 2026, and our Selective EP300 degrader continues to show broad spectrum efficacy across hematological malignancies and favorable tolerability in preclinical studies, differentiating it from dual CBP/EP300 approaches." Foghorn's Selective EP300 degrader demonstrated robust preclinical anti-tumor activity across over 70% of hematological sub-lineages tested with favorable tolerability including no significant thrombocytopenia, while its Selective ARID1B degrader is advancing toward in vivo proof of concept in 2026 with relevance in up to 5% of solid tumors including endometrial, gastric, gastroesophageal junction, bladder, and non-small cell lung cancer. The company reported collaboration revenue of $8.2 million for the third quarter ended September 30, 2025, compared to $7.8 million in the prior year period, with a net loss of $15.8 million. OmniAb, Inc. (NASDAQ: OABI) reported Q3 2025 revenue of $2.2 million as the antibody discovery platform company continued expanding its partnered pipeline with 104 active partners and 399 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized as of September 30, 2025. The company maintained $59.5 million in cash and investments while advancing multiple partner oncology programs, including Immunovant's batoclimab showing 80% response rates in Graves' disease patients and Arcus Biosciences' zimberelimab demonstrating 26.7 months median overall survival in gastroesophageal cancer. "Throughout the third quarter we continued to execute on our strategic initiatives while further demonstrating the value of our proprietary technology platform to a growing base of partners," said Matt Foehr, CEO of OmniAb. "In August we completed a private placement and strengthened our balance sheet while continuing to expand our suite of leading-edge technologies. We look forward to next month's launch of OmniUltra™, an important new technology that we expect will expand our platform and open new business opportunities." OmniAb plans to launch its new OmniUltra™ transgenic chicken platform in December 2025 at the Antibody Engineering & Therapeutics conference, featuring cow-like antibodies with exceptionally long complementarity-determining regions. Partner highlights included Aptevo Therapeutics reporting 100% remission rates with mipletamig in acute myeloid leukemia and CStone Pharmaceuticals securing European approval recommendations for sugemalimab in non-small cell lung cancer. Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX) delivered positive Phase 1b/2 results from its TUPELO trial of REC-4881, an investigational allosteric MEK1/2 inhibitor for familial adenomatous polyposis, with 75% of evaluable patients showing reductions in total polyp burden and a 43% median reduction after 12 weeks of treatment. Notably, 82% of evaluable patients maintained durable reductions at Week 25—12 weeks after stopping therapy—with a 53% median decrease from baseline, marking the first clinical validation of the Recursion OS platform. "These Phase 2 results mark a meaningful validation of the Recursion OS," said Chris Gibson, Ph.D., CEO of Recursion. "An unbiased phenotypic insight from our platform and driven by AI—linking MEK1/2 inhibition to APC loss-of-function biology—has now translated into rapid, substantial, and durable reductions in polyp burden in patients. This is a powerful example of how even the earliest versions of the Recursion OS can uncover therapeutic opportunities in diseases with no approved pharmacotherapy options." The TechBio company plans to engage the FDA in the first half of 2026 to define a potential registration pathway while expanding the trial population from ≥55 to ≥18 years old and optimizing the dosing schedule. REC-4881 demonstrated a safety profile consistent with MEK1/2 inhibition, with the majority of treatment-related adverse events being Grade 1 or 2, Grade 3 events occurring in 15.8% of safety-evaluable patients, and no Grade ≥4 events reported to date. Article Sources: CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by Equity Insider on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of GT Biopharma, Inc. but reserve the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of GT Biopharma, Inc. by CDMG; this is a paid advertisement, we currently own shares of GT Biopharma, Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: 1. 2. 3. 4. Logo - 21% more press release views with Request a Demo

Clinical ResultPhase 1ImmunotherapyPhase 2

03 Dec 2025

·www.biospace.com

Top 5 VC Raises by Women-Founded Biopharmas

iStock, Vanz Studio Venture capital flow to women-founded companies has stabilized in the post-pandemic environment. BioSpace looks back at five companies that have nabbed the most over the past two decades. Biopharmas with women founders have contributed $64.1 billion in venture capital dollars across 3,375 deals since 2008, according to a recent analysis by PitchBook . 2025 has been a particularly good year for female-founded companies across all sectors, with $103.7 billion invested across 2,528 deals so far, according to PitchBook. Zeroing in on biopharma, the capital flow suggests that investment in female-founded companies is stabilizing in the post-pandemic environment. In 2025 so far, female-founded biopharmas have taken in $4.8 billion across 203 deals. This is a significant drop from the peak in 2021, when $12.7 billion in venture capital was recorded for this category across 412 transactions. Since then, the numbers have declined as the sugar buzz wore off—a trend that is reflected across biopharma, regardless of the gender of the founders. Much of the cash for women-founded biopharmas has centered in the U.S.’ two key biotech hubs: the Boston-Cambridge area, which saw $24.4 billion in investment across 759 total deals, and San Francisco-Oakland, where 618 deals netted $16.3 billion. Investment rounds were split equally across early, late and angel rounds. Female-only founded companies took in $7.7 billion in 509 deals, compared to $56.4 billion over 2,866 deals for biopharmas co-founded by women and men. The largest deal in the 16 years for which PitchBook has data was EQRx, which brought in $570 million in a series B in January 2021. The company, which has since gone out of business, had six founders including Melanie Nallicheri, Susan Hager and Sandra Horning. Below, BioSpace looks back at the top five rounds since 2008 and where the companies are today. EQRx Deal Size: $570 million Round: B Founders: Alexis Borisy, Melanie Nallicheri, Robert Forrester, Susan Hager, Peter Bach and Sandra Horning After a massive fundraising push over three years that raised a total of $1.97 billion, the ending for EQRx was not happy. The company emerged with a big goal : to develop medicines that were not just innovative, but affordable. EQRx jumped to the markets quickly through a special purpose acquisition company (SPAC) in August 2021, picking up another $1.8 billion in proceeds. But the lofty goal quickly met with clinical reality. The biotech’s antibody sugemalimab stumbled in the clinic, leaving executives reeling. EQRx pivoted to two other candidates, then ditched the low-cost goal. The staff was slashed in half, and EQRx later sold itself to Revolution Medicines in August 2023, preserving $1 billion in capital for that company. All of EQRx’s assets were terminated and returned to partners. Neumora Deal Size: $500 million Round: A Founders: Paul Berns, Kristina Burow, Robert Nelsen, Mike Poole, Morgan Sheng and Carol Suh Believe it or not, a $500 million series A was not enough to earn Neumora the title of largest VC fundraise of 2021. Abogen’s whopping $700 million round nabbed that top slot. But that’s the nature of that year, when investors flocked to the sector buoyed by the hopeful innovation of COVID-19 vaccines that arrived at the end of 2020 to combat the pandemic. Neumora was the fourth largest VC round of 2021—and that still made waves in the sector . The company emerged with the cash and a partnership with Amgen to develop therapies for neurodegenerative disorders. It has now raised a total of $987 million, including a $250 million IPO in September 2023, according to PitchBook data. The path has not been a straight line for Neumore, however. In April 2024, the FDA slapped a clinical hold on the biotech’s schizophrenia asset as preclinical safety signals emerged. But Neumora plowed on, unfortunately revealing a Phase III failure for the kappa opioid receptor (KOR) antagonist navacaprant in major depressive disorder in January this year. With two additional trials expected to readout for the drug this year, Neumora changed things up in March and pushed out the timeline to 2026. After fielding all these challenges, Neumora is now on the cusp of releasing key Alzheimer’s disease data for NMRA-511. This could be the moment that $500 million seems worthwhile for investors. Lyell Immunopharma Deal Size: $493 million Round: C Founders: Rick Klausner, Crystal Mackall and Stan Riddell Lyell Immunopharma was ahead of the pandemic-influenced biotech funding curve with a massive $493 million series C round in March 2020. Since then, the company has continued to battle in the tough cell therapy space, using its influx of cash from various fundraising mechanisms to bring in new approaches to address the modality’s limitations. Founded by a team of cell therapy experts, Lyell has promised to develop next generation CAR T cell therapies for blood cancer and solid tumors by addressing T cell exhaustion and durability. Riding the wave of biotechs heading for the public markets in 2021, Lyell pulled off a massive $425 million IPO in June. Lyell’s GSK-partnered T cell receptor therapy hit the clinic the next year, but the success was short lived as the Big Pharma walked away from the $250 million three-year partnership months later. Continuing on, Lyell reported mixed Phase I data for the CAR T therapy LYL797 in solid tumors in June 2024. The results revealed strong response rates across patients, but a death and high rates of cytokine release syndrome marred the readout. The asset was discontinued in October 2024, just as Lyell bought ImmPACT Bio for $30 million in cash plus shares. The heart of that deal was an autologous dual-targeting CD19/CD20 CAR T, now known as rondecabtagene autoleucel (ronde-cel). Lyell began a pair of pivotal trials for the candidate this year, including a head-to-head test pitting ronde-cel against approved CD19 CAR T cell therapies, including Bristol Myers Squibb’s Breyanzi or Gilead’s Yescarta. Lyell also followed the biopharma trend and picked up a new CAR T cell candidate from China’s Innovative Cellular Therapeutics . Laronde Deal Size: $440 million Round: B Founders: Avak Kahvejian, Noubar Afeyan, Nicholas Plugis, Erica Weinstein, Sophie Boer This Flagship Pioneering–backed startup vowed to champion a new form of RNA medicines called Endless RNA upon launch in 2021 . The company rode the success of Moderna—the star of Flagship’s portfolio—to a $440 million series B months after the public debut in July 2021. But the journey was short lived. In June 2023, STAT published an expose on data integrity issues at the biotech. The company could not replicate the preclinical data that had underpinned the massive raise. Laronde cut two programs and many employees were forced to resign, including CEO Pablo Cagnoni. Flagship folded the embattled biotech into another of its portfolio companies, Senda Biosciences, to form Sail Biomedicines in October 2023. That biotech is continuing the eRNA mission but has yet to enter the clinic. BioNTech Deal Size: $425 million Round: N/A Founders: Ugur Sahin, Özlem Türeci and Christoph Huber BioNTech’s story has been told over and over—the Pfizer-partnered pandemic savior developed one of the two COVID-19 vaccines that helped bring the world back from the crisis. This generated billions in revenue and has helped fuel the biotech’s next phase. But step back to January 2019, when the German mRNA company raised a remarkable $425 million, and you’ll see that BioNTech always had big ambitions. This later-stage round involved just two pharma entities: Pfizer Ventures with $333.5 million in cash and Sanofi with $91.5 million, according to Pitchbook data. The company followed that year with a more traditional series B in July that totaled $325 million . These fundraises primed the biotech to enter the first year of the pandemic fully charged and ready for some R&D. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! 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VaccinePhase 1AcquisitionIPOClinical Result

20 Oct 2025

·www.prnewswire.com

ESMO 2025: CStone Discloses Phase I Data for CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

SUZHOU, China, Oct. 19, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, today announced the first disclosure of preliminary Phase I data for CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody) and the Phase Ib study design for CS5001 (a ROR1-targeted Antibody-Drug Conjugate [ADC]) at the 2025 European Society for Medical Oncology (ESMO) Annual Congress. Key Highlights of CS2009 Poster Presentation: This also represents the first known clinical data publication of a PD-1/VEGF/CTLA-4 trispecific antibody to date. CS2009-101 is a multi-regional phase Ⅰ study currently ongoing in Australia and China. The study evaluates the safety, tolerability, pharmacokinetics (PK)/ pharmacodynamics (PD), and antitumor activity of CS2009 in patients with advanced solid tumors. Patients baseline characteristics: As of the data cutoff date, 72 patients with advanced solid tumors treated across 6 dose levels (DL1-6, 1-45 mg/kg); 72.2% remain on treatment. Heavily pretreated population: over 51% received prior immuno-oncology (IO) therapies. Median follow-up: only 1.9 months (range 0.1-6.7 months) at data cutoff. Favorable safety and tolerability: Dose escalation completed with no dose-limiting toxicity (DLT) reported; maximum tolerated dose (MTD) not reached. No Grade 4 or 5 treatment-related adverse event (TRAE) observed. Incidence of Grade ≥ 3 TRAEs, immune-related AEs (irAEs), and VEGF-related TRAEs was 13.9%, 4.2%, and 2.8%, respectively. Only 1 treatment-emergent adverse event (TEAE) leading to drug permanent discontinuation observed (at DL4 [20 mg/kg]; 1.4% incidence). Promising antitumor activity and high disease control rate (DCR): CS2009 demonstrated encouraging anti-tumor activities across tumor types. As of the cutoff date, the overall follow-up duration remained limited, particularly in higher-dose cohorts where the majority patients had yet to reach the protocol-specified time point of post-baseline tumor assessment: 49/72 patients underwent at least one post-baseline tumor assessment by data cutoff. Despite limited follow-up duration, anti-tumor activity was observed across all dose levels with dose-dependent uptrend: Among all 49 evaluable patients, overall response rate (ORR) was 12.2%; DCR was 71.4%. Efficacy data remains immature; with additional follow-up beyond the poster data cutoff, ORR was further improved to 14.3%. Higher ORR (25.0%) at tentative recommended Phase 2 dose (RP2D, 30 mg/kg) and higher dose. Promising efficacy signals were observed across multiple tumor types within the short follow-up period: Non-Small Cell Lung Cancer (NSCLC): ORR: 11.8%, DCR: 82.4%; Post-ESMO update: stable disease (SD)-to-partial response (PR) conversion observed, ORR further elevated to 17.6%; In AGA-negative subgroup, ORR reached 25%; Ovarian Cancer (OC): ORR: 16.7%, DCR: 66.7%; Triple-Negative Breast Cancer (TNBC): ORR: 25.0%, DCR: 75.0%; Non–Clear Cell Renal Cell Carcinoma (nccRCC): ORR: 33.3%, DCR: 100.0%; Soft Tissue Sarcoma (STS): ORR: 11.1%, DCR: 66.7%. Favorable PK and PD profiles: Linear PK with half-life of 6-8 days supported every-three-week (Q3W) dosing, with no significant accumulation observed at cycle 3. PD profile demonstrated saturated receptor occupancy and robust T-cell activation/proliferation confirming PD-1/CTLA-4 blockade and deep and sustained VEGFA neutralization. Receptor occupancy of PD-1/CTLA-4 on peripheral T cells reached saturation throughout dosing interval at doses ≥20 mg/kg. On cycle 1 day 8, CS2009 induced notable, dose-dependent upregulation of Ki67 (proliferation due to PD-1 and CTLA-4 blockade) and ICOS (activation due to CTLA-4 blockade) expression on both CD4+ and CD8+ T cells, collectively demonstrating effective PD-1 and CTLA-4 inhibition. Serum-free VEGFA reduced deeply and rapidly across all dose levels, and the effect sustained throughout dose intervals. CStone has initiated Phase Ⅱ dose expansion study in first-line patients with selected tum or types for dose optimization and to generate data supporting registration trials in first-line NSCLC and other tumors as monotherapy or in combination therapies. CS2009 Data Review Conference Call: CStone will host an investor meeting to discuss presented data and future clinical development plan. The Company cordially invites all investors to attend this conference call. Chinese-language session: Date & Time: Monday, October 20, 2025, at 2:00 p.m. (Beijing Time)/2:00 a.m. (US Eastern Time) Registration Link: Registration is required, please sign up via the link: English-language session: Date & Time: Monday, October 20, 2025, at 9:00 p.m. (Beijing Time)/9:00 a.m. (US Eastern Time) Registration Link: The Zoom meeting link will be sent to you by email after registration via the below link. You may join the meeting by clicking the link in email: Key Highlights of CS5001 ePoster Presentation: CS5001 phase Ib study aims to determine the RP2D and further evaluate the safety, tolerability, PK, and efficacy of CS5001 as a monotherapy and in combination with systemic therapies in selected tumor types. In monotherapy cohorts, Cohorts A-D enroll patients with chronic lymphocytic leukemia and other B-cell lymphomas, and Cohort I enrolls patients with ROR1-positive solid tumors. In combination therapy cohorts (E-H), CS5001 will be administered with standard systemic therapies (R-GemOx, R2 or R-CHOP) or with sugemalimab (an anti-PD-L1 monoclonal antibody). Patient enrollment for CS5001 Phase Ib study commenced in December 2024 and is currently advancing smoothly at 30 sites across Australia, the United States, and China. About CStone CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit: . Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultADC

100 Deals associated with Sugemalimab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	United Kingdom	Cornerstone Pharmaceutical Co., Ltd	23 Feb 2026
Non-small cell lung cancer stage III	European Union	CStone Pharmaceuticals Co. Ltd.	27 Nov 2025
Non-small cell lung cancer stage III	Iceland	CStone Pharmaceuticals Co. Ltd.	27 Nov 2025
Non-small cell lung cancer stage III	Liechtenstein	CStone Pharmaceuticals Co. Ltd.	27 Nov 2025
Non-small cell lung cancer stage III	Norway	CStone Pharmaceuticals Co. Ltd.	27 Nov 2025
Unresectable Lung Non-Small Cell Carcinoma	European Union	CStone Pharmaceuticals Co. Ltd.	25 Mar 2025
Unresectable Lung Non-Small Cell Carcinoma	Iceland	CStone Pharmaceuticals Co. Ltd.	25 Mar 2025
Unresectable Lung Non-Small Cell Carcinoma	Liechtenstein	CStone Pharmaceuticals Co. Ltd.	25 Mar 2025
Unresectable Lung Non-Small Cell Carcinoma	Norway	CStone Pharmaceuticals Co. Ltd.	25 Mar 2025
metastatic non-small cell lung cancer	European Union	CStone Pharmaceuticals Co. Ltd.	24 Jul 2024
metastatic non-small cell lung cancer	Iceland	CStone Pharmaceuticals Co. Ltd.	24 Jul 2024
metastatic non-small cell lung cancer	Liechtenstein	CStone Pharmaceuticals Co. Ltd.	24 Jul 2024
metastatic non-small cell lung cancer	Norway	CStone Pharmaceuticals Co. Ltd.	24 Jul 2024
Gastroesophageal junction adenocarcinoma	China	Cornerstone Pharmaceutical Co., Ltd	12 Mar 2024
Stomach Cancer	China	Cornerstone Pharmaceutical Co., Ltd	12 Mar 2024
Esophageal Squamous Cell Carcinoma	China	Cornerstone Pharmaceutical Co., Ltd	08 Dec 2023
Esophageal Squamous Cell Carcinoma	China	Pfizer Inc.	08 Dec 2023
Extranodal NK-T-Cell Lymphoma	China	Cornerstone Pharmaceutical Co., Ltd	27 Oct 2023
Extranodal NK-T-Cell Lymphoma	China	Pfizer Investment Co. Ltd.	27 Oct 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	China	Cornerstone Pharmaceutical Co., Ltd	20 Dec 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Gastroesophageal Junction Adenocarcinoma	NDA/BLA	China	Pfizer Investment Co. Ltd.	28 Feb 2023
Non-Small Cell Lung Cancer	NDA/BLA	China	WuXi Biologics (Cayman), Inc.	13 Nov 2020
Non-Small Cell Lung Cancer	NDA/BLA	China	Cornerstone Pharmaceutical Co., Ltd	13 Nov 2020
Locally Advanced Esophageal Squamous Cell Carcinoma	Phase 3	China	CStone Pharmaceuticals Co. Ltd.	19 Dec 2019
Unresectable Esophageal Squamous Cell Carcinoma	Phase 3	China	CStone Pharmaceuticals Co. Ltd.	19 Dec 2019
Locally Advanced Unresectable Gastric Adenocarcinoma	Phase 3	China	CStone Pharmaceuticals Co. Ltd.	28 Mar 2019
stomach adenocarcinoma	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	22 Jan 2019
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	13 Dec 2018
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	CStone Pharmaceuticals Co. Ltd.	26 Oct 2018
Resectable Lung Non-Small Cell Carcinoma	Phase 2	China	Pfizer Inc.	19 Jun 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03802591 (GEMSTONE-303, PRNewswire \| Pubmed) Manual	Phase 3	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line PD-L1 Positive	-	Sugemalimab + CAPOX	glwcixgzyo(rjpsknesyh) = awrukicwgs vnwfkkahss (tohbcroexy, 13.3 - 17.8) View more	Positive	24 Feb 2025
				Placebo + CAPOX	glwcixgzyo(rjpsknesyh) = ccuzixlant vnwfkkahss (tohbcroexy, 10.6 - 14.1) View more
NCT03789604 (GEMSTONE-302, ESMO2024 \| Pubmed) Manual	Phase 3	metastatic non-small cell lung cancer First line	479	Sugemalimab + Platinum-based chemotherapy	qelqwkvnff(hihichfpqj) = msvebkeupk jafeiotkqi (xdneeyxbuj ) View more	Positive	14 Sep 2024
				Placebo + Platinum-based chemotherapy	qelqwkvnff(hihichfpqj) = ouiegjdtkp jafeiotkqi (xdneeyxbuj ) View more
NCT03595657 (GEMSTONE-201, CTgov)	Phase 2	Extranodal NK-T-Cell Lymphoma	80	sugemalimab (CS1001)	vjuxuqxtwy = sbfeyajodc hrzkvmpdil (zeipidpdoo, pclvrhvqxe - wkjnqdqwti) View more	-	18 Jun 2024
ASCO2024 Manual	Not Applicable	Non-Small Cell Lung Cancer Second line \| First line	-	Sugemalimab plus platinum-based chemo	rhjutqorzz(hunvxnhpoi) = gboinkbncb bazzkcgydh (hvwhpdnbut ) View more	Positive	24 May 2024
				Sugemalimaby (RT) plus Sugemalimab	zxivtxnztj(oouwmrfhho) = gfqoojelcz fyvwunikrn (osxgzvlopn ) View more
NCT04187352 (Literature \| Pubmed \| Nat Med) Manual	Phase 3	Advanced Esophageal Squamous Cell Carcinoma First line	540	sugemalimab+chemotherapy	cvnaxlvjud(zbwnsqzrpc) = ctdspzirvt qlxtejnkzt (cnvfgihyot ) View more	Positive	01 Feb 2024
				placebo+chemotherapy	cvnaxlvjud(zbwnsqzrpc) = mpnxhmekob qlxtejnkzt (cnvfgihyot ) View more
NCT03802591 (GEMSTONE-303, ESMO 12023 \| ESMO 22023) Manual	Phase 3	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma First line PD-L1 expression	479	Sugemalimab + CAPOX (PD-L1 Expression Level >=5%)	gopwynscyr(dohqkoggur) = kxcmkowymi ahljxbnhoz (ptbczwolxr, 13.27 - 17.81) View more	Positive	21 Oct 2023
				Placebo + CAPOX (PD-L1 Expression Level >=5%)	gopwynscyr(dohqkoggur) = wigaicyxhx ahljxbnhoz (ptbczwolxr, 10.64 - 14.06) View more
NCT04187352 (GEMSTONE-304, ESMO_GI2023)	Phase 3	Unresectable Esophageal Squamous Cell Carcinoma First line PD-L1	540	Sugemalimab + FP	umjgjutcfl(ysmbkdezuc) = kmfhxudpvq gkcdzrgfid (zogyxihtkb ) View more	Positive	01 Jul 2023
				Placebo + FP	umjgjutcfl(ysmbkdezuc) = ilvfhccwox gkcdzrgfid (zogyxihtkb ) View more
NCT03789604 (GEMSTONE-302, ASCO2023)	Not Applicable	Non-Small Cell Lung Cancer First line	-	Sugemalimab + chemotherapy	injsckgllu(jlsnxwvboq) = jnprenfhij xnqhyyscdu (pzqvbzzpuv )	Positive	31 May 2023
				Placebo + chemotherapy	injsckgllu(jlsnxwvboq) = eqddlzdacf xnqhyyscdu (pzqvbzzpuv )
NCT03595657 (GEMSTONE-201, Pubmed)	Phase 2	Extranodal NK-T-Cell Lymphoma	80	Sugemalimab	lvvatlnvim(vlmtggsfdx) = fomohwhoos oevlriasgc (yvsudjealb, 33.6 - 56.6) View more	Positive	30 Mar 2023
NCT03802591 (GEMSTONE-303, Corporate Publications) Manual	Phase 3	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma First line PD-L1	-	Oxaliplatin+Capecitabine+Sugemalimab	pyxwymnypv(vlwfwpkwlg) = zdbisijnpk nkmrtqshvx (tzppgukurm ) View more	Positive	11 Nov 2022
				Oxaliplatin+Capecitabine+Placebo	pyxwymnypv(vlwfwpkwlg) = sjwzbncbhq nkmrtqshvx (tzppgukurm ) View more

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