On January 23, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the initiation of new clinical sites in the US (Press release, Greenwich LifeSciences, JAN 23, 2025, View Source [SID1234649850]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Both Harvard University and Johns Hopkins University sites were recently added as participating sites in FLAMINGO-01 in the US and both principal investigators, Dr. Laura Spring and Dr. Cesar Santa-Maria have joined the Steering Committee.

The Steering Committee is now comprised of the following experts in the field of breast cancer oncology representing prominent teaching hospitals in the US and 4 of the largest breast oncology networks in the US, Germany, France, and Spain:

Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
Dr. Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University, Head of Breast Cancer Group, Institut Curie, Vice-Chair of the French Breast Cancer research group UCBG (Unicancer)
Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
Dr. Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH & Chair of the German Breast Group (GBG)
Dr. Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón General University Hospital, Complutense University, Madrid, CEO of GEICAM
Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
Dr. Hope S. Rugo – Professor of Medicine and Winterhof Family Professor of Breast Oncology and Director, Breast Oncology and Clinical Trials Education, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
Dr. Cesar A. Santa-Maria – Associate Professor of Oncology, Breast and Gynecological Malignancies Group, Director of Breast Cancer Trials, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Dr. Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending Physician, Medical Oncology, Massachusetts General Hospital

Dr. Spring is a clinical/translational investigator and breast medical oncologist at the Massachusetts General Hospital Cancer Center (MGH) and Harvard Medical School. She is board certified in internal medicine and medical oncology. Dr. Spring completed residency training at Brigham & Women’s Hospital and her medical oncology training through the Dana-Farber/Mass General Brigham Cancer Care Oncology Fellowship Program.

The primary focus of her research is to develop novel therapeutic and biomarker strategies to improve the care of patients with breast cancer. She is particularly interested in blood-based monitoring of localized breast cancer and the use of targeted therapies in the neoadjuvant setting. Dr. Spring is involved with the design and conduct of several breast cancer clinical trials for localized and metastatic breast cancer.

Dr. Spring commented, "We are excited to offer the FLAMINGO-01 trial at MGH for patients with high-risk HER2-positive breast cancer. There is high patient and physician interest in vaccine strategies to reduce recurrence risk."

Dr. Santa-Maria is a board-certified medical oncologist, and Associate Professor of Oncology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and Director of Breast Clinical Trials in the Breast and Gynecological Malignancies Disease Group. He is a nationally recognized clinical translational researcher in breast immunotherapy, including development of novel vaccines. His work is funded by numerous grants from the NIH, DOD, and several prestigious cancer foundations (ASCO, CCF, BCRF, SGK). He serves on the NCI’s Breast Immuno-oncology (BIO) Task Force and the NCCN and holds leadership positions in the ETCTN and TBCRC.

Dr. Santa-Maria commented, "I am thrilled to be opening the FLAMINGO-01 at Johns Hopkins and offering this study for our patients with high-risk HER2-positive breast cancer. A vaccine approach is particularly well suited to this patient population who have completed standard therapy, as risk still remains, and secondary prevention strategies are urgently needed."

Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "Greenwich is honored to be working with a stellar collection of clinical trial sites around the globe. The institutions, represented by Dr. Spring and Dr. Santa-Maria, exhibit the caliber of sites participating in FLAMINGO-01."

CEO Snehal Patel commented, "Dr. Spring’s interest in biomarkers and targeted therapies, including HER2 as a target where immune response could be potentially monitored through skin or blood tests, and Dr. Santa-Maria’s background and commitment to breast immunotherapy, including novel vaccines, makes for very strong additions to the FLAMINGO-01 Steering Committee. We look forward to collaborating with these new members of the Steering Committee who will help guide us in FLAMINGO-01 and share with us their experiences in enrolling and treating patients in their key geographic locations, while also furthering their research interests."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On January 23, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the first patient has been enrolled and dosed in the Phase 2 expansion portion of the Company’s Acclaim-3 clinical study of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with Tecentriq (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) (Press release, Genprex, JAN 23, 2025, View Source [SID1234649849]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to begin the Phase 2 expansion portion of Acclaim-3, which will determine the 18-week Progression Free Survival (PFS) rate of REQORSA and Tecentriq combination maintenance therapy," said Mark Berger, MD, Chief Medical Officer at Genprex. "ES-SCLC has a poor prognosis with a median PFS of 5.2 months. Those patients receiving Tecentriq as maintenance therapy have a median PFS of 2.6 months after the start of maintenance therapy. We look forward to studying the combination of REQORSA and Tecentriq as we work to advance our innovative gene therapy."

The Phase 2 expansion portion will enroll 50 patients at approximately 10 to 15 U.S. sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 interim analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients in the second half of 2025 for interim analysis.

The combination of REQORSA and Tecentriq previously received the U.S. Food and Drug Administration’s (FDA) Fast Track Designation for the treatment of the Acclaim-3 patient population, and the FDA has also granted Orphan Drug Designation to REQORSA for the treatment of SCLC.

Genprex has a novel cancer treatment platform that re-expresses tumor suppressor genes in cancers. Tumor suppressor genes are often deleted or inactivated early in the process of cancer development. REQORSA contains a plasmid that expresses TUSC2, a tumor suppressor gene protein. Nearly 100% of SCLCs have reduced or no TUSC2 protein expression, and 41% completely lack TUSC2 protein expression. Nonclinical studies in mice support the hypothesis that re-expressing the TUSC2 protein may lead to improved clinical efficacy in combination with Tecentriq.

Data presented at the October 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) from studies in humanized mouse models of SCLC that use human H841 SCLC cells have shown that the combination of REQORSA and Tecentriq provides significantly better control of tumor burden than either agent alone. The data from these studies also suggest that a combination treatment of REQORSA and Tecentriq can promote a significantly increased tumor cell killing effect in SCLC xenografts compared to that of Tecentriq alone.

About Acclaim-3

The Acclaim-3 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, Reqorsa Gene Therapy, in combination with Genentech, Inc.’s Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.

On January 23, 2025 Cancer Research UK, Cytovation and the Norwegian Cancer Society reported to have signed an agreement to bring Cytovation’s lead asset, CY-101, into a multi-national Phase 2 clinical trial for patients with adrenocortical carcinoma (ACC) (Press release, Cytovation, JAN 23, 2025, View Source;utm_medium=rss&utm_campaign=cancer-research-uk-cytovation-and-the-norwegian-cancer-society-collaborate-to-advance-treatment-for-rare-cancer [SID1234649848]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This rare and aggressive cancer, which affects the adrenal glands, has limited treatment options and an urgent need for new therapies.

CY-101, developed by Cytovation, is a synthetic peptide with a dual function. It selectively targets and destroys cancer cells, triggering a systemic immune response, while simultaneously inhibiting the Wnt/β-catenin signalling pathway, a key driver of immunotherapy resistance in cancers such as ACC.

CY-101’s development builds on compelling data from Cytovation’s Phase 1 CICILIA trial, which demonstrated encouraging outcomes in patients with solid tumours. Notably, two ACC patients had clear clinical benefit, with one achieving 18 months of progression-free survival and continuing treatment on a named-patient basis. These results highlight CY-101’s potential to address the specific mechanisms of ACC.

A collaborative approach
Under the agreement, Cancer Research UK’s Centre for Drug Development (CDD) will sponsor, design and deliver the Phase 2 trial and Cytovation will be responsible for providing CY-101 for the clinical trial. Cancer Research Horizons, Cancer Research UK’s innovation arm, will manage the commercial relationship between the three parties.

The Norwegian Cancer Society’s support provides access to the additional resources, patients and sites required for trials in rare diseases. Due to the rarity of ACC, the clinical trial will run across multiple sites in the UK and Europe, to ensure robust patient recruitment.

Lars Erwig, Director of the Centre for Drug Development, Cancer Research UK, said: "This collaboration represents a critical step toward addressing the needs of ACC patients who currently have very few treatment options. Cytovation has made impressive progress with CY-101 so far and we are excited to build on our existing partnership with the Norwegian Cancer Society to take its development further."

Lars Prestegarden, CEO, Cytovation, said: "We are very excited about this partnership, proud to follow in the footsteps of groundbreaking agents that Cancer Research UK has contributed to developing, and honoured by the Norwegian Cancer Society’s support. We believe CY-101 has the potential to be transformational for the treatment of ACC and other cancer types and are eager to bring this innovation to patients."

Ingrid Stenstadvold Ross, CEO of the Norwegian Cancer Society, said: "The partnership with Cancer Research UK’s Centre for Drug Development marks a milestone for the Norwegian Cancer Society, enabling us to advance the development of groundbreaking cancer treatments. We are thrilled that our first joint project is a Norwegian innovation, focused on patients with a rare cancer and a substantial unmet need. Together with Cancer Research UK’s Centre for Drug Development and Cytovation, we are bringing new hope to patients while highlighting Norwegian research on the international stage."

On January 23, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, reported positive updated data from the ASPEN-06 Phase 2 clinical trial demonstrating that the company’s investigational CD47-blocker evorpacept generates a durable clinical response with a well-tolerated safety profile among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer (Press release, ALX Oncology, JAN 23, 2025, View Source [SID1234649845]). The updated results, which build upon previously announced topline results, will be shared today in an oral presentation (Abstract #332) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in San Francisco.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The updated data from the ASPEN-06 trial highlight the potential clinical utility of CD47 inhibition from evorpacept in combination with trastuzumab, ramucirumab and paclitaxel in patients with previously treated HER2-positive gastric cancer," said Kohei Shitara, M.D., Director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan and the study’s presenter. "Overall, the findings suggest that evorpacept generates durable and clinically meaningful anti-tumor activity in this population of patients who had previously received a HER2-targeted agent, with the largest benefit among those patients with confirmed HER2-positive disease."

ASPEN-06 is a randomized, multi-center, international trial (NCT05002127) evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated proprietary Fc domain, in combination with trastuzumab, CYRAMZA (ramucirumab) and paclitaxel (collectively, ETRP) against trastuzumab, ramucirumab and paclitaxel (TRP) alone for the treatment of patients with HER2-positive gastric/GEJ cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. Patients were enrolled with either archival or fresh HER2-positive biopsies.

The trial’s primary endpoints were investigator-assessed overall response rate (ORR) in the intent-to-treat (ITT) population and in the population of patients with fresh HER2-positive biopsies, compared to both internal control (TRP) and historical control (ramucirumab and paclitaxel, or RP). Key secondary endpoints were safety, duration of response (DOR), progression-free survival (PFS) and overall survival (OS). The updated dataset being presented today includes results from a December 2, 2024 data cut, including an analysis that assessed patients with HER2-positive tumors via circulating tumor DNA (ctDNA) at baseline. Overall survival data were not yet mature at the time of data cut.

Updated trial results to be shared today at 2025 ASCO (Free ASCO Whitepaper) GI include:

Primary endpoints (December data cut):
ITT patient population ORR (N=127): Evorpacept plus TRP (ETRP) demonstrated an ORR of 41.3% compared to 30% for RP historical control and 26.6% for TRP control.
Fresh HER2-positive biopsy patient population ORR (n=48): ETRP demonstrated an ORR of 59.1% compared to 30% for RP historical control and 23.1% for TRP control.
In the ITT population, ETRP demonstrated a median DOR (mDOR) of 15.7 months and a median PFS (mPFS) of 7.5 months compared to an mDOR of 9.1 months and mPFS of 7.4 months in the TRP control group, with a PFS Hazard Ratio (HR) in this population of 0.77.
In patients with fresh HER2-positive biopsies, ETRP demonstrated an mDOR of 15.7 months and mPFS of 9.5 months compared to an mDOR of 14.5 months and 7.1 months in the TRP control group, with a PFS HR of 0.62.
In patients with confirmed HER2-positive expression as determined by either fresh biopsy or ctDNA HER2-positivity (n=96), the addition of evorpacept to TRP resulted in a 48.9% ORR, an mDOR of 15.7 months and mPFS of 7.5 months, compared to 24.5% ORR, an mDOR of 9.1 months and mPFS of 6.7 months in the TRP control group, with a PFS HR of 0.64.
Evorpacept plus TRP was generally well tolerated, with the incidence of adverse events in the evorpacept population consistent with those in TRP control.
"The results from this trial tell a clear story that when a cancer cell is expressing HER2, evorpacept can combine with a regimen containing an anti-HER2 antibody such as trastuzumab to improve upon the activity you would expect from that regimen alone," said Alan Sandler, M.D., Chief Medical Officer at ALX Oncology. "This is evidenced by the near doubling of PFS at one year among the patients with HER2-positivity confirmed via either fresh biopsy or ctDNA who received ETRP vs control. Additionally, the analysis of this patient population affirms HER2-expression is a key biomarker for evorpacept efficacy and validates the strategy behind evorpacept’s novel design."

The updated ASPEN-06 data add to positive findings from a Phase 1b/2 trial recently presented at the 2024 San Antonio Breast Cancer Symposium (SABCS). These findings suggested that patients with heavily pretreated HER2-positive advanced breast cancer had anti-tumor activity from CD47 inhibition with evorpacept when it is combined with a HER2-targeted agent.

"The dataset shared today from the ASPEN-06 randomized clinical trial suggests durable clinical benefit driven by evorpacept and a differentiated safety profile – a first for any CD47 blocker," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Based on the collective clinical data we’ve now seen across patients with HER2-positive gastric and breast cancers, we believe evorpacept is working as designed in combination with antibodies when there is HER2 expression, even when patients had been previously treated with other HER2-directed therapies. We look forward to sharing the updated ASPEN-06 data with the FDA and are confident in our path to pursue evorpacept as a therapeutic option for patients."

A copy of the 2025 ASCO (Free ASCO Whitepaper) GI presentation will be available in the "Publications" section of the ALX Oncology website following the presentation.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication.

Company Conference Call and Webcast on January 23 at 1:00 PM PT/4:00 PM ET
ALX Oncology will host a conference call and webcast today at 1:00 PM PT/4:00 PM ET to review the updated ASPEN-06 data. The event will be webcast live and a replay will be available after the call by visiting the "Investors" section of ALX Oncology’s website and selecting "Events and Presentations".

Date & Time: Thursday, January 23, 1:00 PM PT/4:00 PM ET
Webcast Access: View Source

On January 23, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand 1(PD-L1)-directed innovative humanized monoclonal antibody ("mAb") tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC) (Press release, Kelun Biotech, JAN 23, 2025, View Source [SID1234649836]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The approval is based on a randomized, double-blinded, placebo controlled, multi-center, phase III clinical study evaluates the efficacy and safety results of tagitanlimab in combination with cisplatin and gemcitabine versus placebo in combination with cisplatin and gemcitabine for the treatment of recurrent or metastatic NPC, which was led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator.

According to the study results, tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment for recurrent or metastatic NPC could have better progression-free survival (PFS), higher objective response rate (ORR) and extended duration of response (DoR) compared with chemotherapy, where all the patients could benefit regardless of the PD-L1 expression. The median PFS for tagitanlimab in combination with chemotherapy is not reached compared to 7.9 months for placebo in combination with chemotherapy (HR=0.47, 95% CI: 0.33-0.66, p<0.0001), and the risk of disease progression and death is reduced by 53%; ORR is 81.7% vs 74.5%; median DoR is 11.7 vs 5.8 months (HR=0.48, 95% CI: 0.32-0.70), which has nearly doubled compared to placebo arm; currently the median overall survival (OS) is still not mature, however the beneficial trend for OS of tagitanlimab in combination with chemotherapy has already been observed (HR=0.62, 95％CI: 0.32-1.22), and its risk of death is reduced by 38%[1]. Tagitanlimab also showed a manageable safety profile.

This is the second indication approved for tagitanlimab. Previously, NMPA has approved the marketing in China of tagitanlimab monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy.

Dr. Micheal Ge, CEO of Kelun-Biotech said, "We are pleased that the second indication of our self-developed PD-L1 monoclonal antibody was successfully approved for marketing and demonstrated statistically significant and clinically meaningful improvements in PFS. For domestic NPC patients, Tagitanlimab has realized a breakthrough in therapeutic coverage and innovation from the backline to the frontline, which once again strongly validates the excellent strength of Kelun-Biotech’s new drug research and development. In the future, the company will always be based on unmet clinical needs, source innovation, and explore more and more excellent clinical therapeutic solutions to benefit more patients."