On April 1, 2025 Hengrui Pharmaceuticals reported the 5-year long-term follow-up data from the CameL-sq study-a randomized, double-blind, multicenter, phase III trial that evaluated the efficacy and safety of camrelizumab vs. placebo in combination with carboplatin and paclitaxel as first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) with negative driver genes (Press release, Hengrui Pharmaceuticals, APR 1, 2025, View Source;year-survival-of-patients-with-advanced-squamous-lung-cancer—a-potential–paradigm-shift-in-clinical-outcome-for-this-difficult-to-treat-population-302416809.html [SID1234651734]). The results show that the 5-year overall survival (OS) rate for patients treated with camrelizumab plus chemotherapy was 27.8%, indicating that more than one-quarter of the patients survived beyond five years., and a 15.3% improvement over the placebo-chemotherapy group (12.5%). Additionally, camrelizumab significantly reduced the risk of mortality by 43%, enabling more patients to achieve long-term survival.

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The five-year survival rate serves as a critical indicator for assessing potential clinical cure in oncology. China’s Healthy China 2030 initiative has established an ambitious target to increase the overall five-year survival rate for cancer patients by 15%. Epidemiologic data from the National Cancer Center consistently identify lung cancer as the malignancy with the highest incidence and mortality rates across both genders. However, early symptoms of lung cancer are frequently overlooked, resulting in most patients being diagnosed at an advanced stage. In the era dominated by traditional chemotherapy, the five-year survival rate for patients with advanced lung cancer was below 10%. Among histologic subtypes, squamous NSCLC presents unique challenges as it does not benefit from targeted therapies, leading to relatively poor survival outcomes. With the advent of immunotherapy drugs, the prognosis for squamous NSCLC has significantly improved; however, numerous unmet clinical needs remain.

Camrelizumab is a humanized IgG4 monoclonal antibody independently developed by Hengrui Pharmaceuticals. With high binding affinity to PD-1, it has been shown to significantly improve the overall survival of patients with various solid tumors, including lung cancer, liver cancer, esophageal cancer, and nasopharyngeal cancer. At the 2024 ELCC, the long-term follow-up data from the CameL study were presented, highlighting the efficacy of camrelizumab in combination with chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer. The findings revealed that approximately one-third of the patients achieved a survival duration exceeding five years.

The significant clinical benefits of camrelizumab plus chemotherapy as demonstrated by the CameL-sq study ( an increase of 15.3% in the five year survival rate compared to the control group), represent a meaningful advancement toward the goals outlined in the Healthy China 2030 blueprint for cancer prevention and control. This breakthrough represents another significant contribution from Hengrui Pharmaceuticals, a leading innovator in China’s pharmaceutical sector, to prolong and improve the lives of cancer patients worldwide.

On April 1, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that results of its investigational drug candidates DZD8586 and DZD6008, have been selected for presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 – June 3, 2025, in Chicago (Press release, Dizal Pharma, APR 1, 2025, View Source [SID1234651733]).

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Oral and poster presentations of its DZD8586 study results in chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL) are selected by ASCO (Free ASCO Whitepaper) Scientific Program Committee. In addition, Dizal will present its 4th generation EGFR TKI clinical data in non-small cell lung cancer (NSCLC) during the conference.

About DZD8586

DZD8586 is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

DZD8586 has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. Phase I clinical trial suggests that DZD8586 exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

About DZD6008

DZD6008, is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.

On April 1, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the Stifel 2025 Virtual Targeted Oncology Forum on Tuesday, April 8, 2025, at 2:30 p.m. ET (Press release, Nuvalent, APR 1, 2025, View Source [SID1234651732]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentations.

On April 1, 2025 Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that it has entered into a definitive agreement for the purchase of 1,739,131 shares of its common stock (or pre-funded warrants in lieu thereof), at a purchase price of $1.15 per share (or pre-funded warrant in lieu thereof) (Press release, Citius Pharmaceuticals, APR 1, 2025, View Source [SID1234651731]). The closing of the offering is expected to occur on or about April 2, 2025, subject to the satisfaction of customary closing conditions.

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

The aggregate gross proceeds to the Company from the offering are expected to be approximately $2 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering to support the commercial launch of LYMPHIR as well as general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

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

On April 1, 2025 Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma), a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune diseases, reported that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registration Phase 3 study of linperlisib versus physicians’ choice of standard of care for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) (Press release, Yingli Pharmaceutical, APR 1, 2025, View Source [SID1234651730]). FDA’s approval of the pivotal Phase 3 protocol follows a successful Type B End-of-Phase 2 meeting, during which Yingli Pharma discussed the overall development program and regulatory path. The Phase 3 study is planned to commence during the second quarter of 2025. Linperlisib is a potent oral small molecule inhibitor of the delta isoform of PI3 kinase (PI3Kδ) developed by Yingli Pharma.

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"This is a major milestone for linperlisib.", said Michael Hui, Chairman and Chief Executive Officer of Yingli Pharma, "We are very excited that linperlisib has entered the global pivotal study stage with the agreement from FDA. We will continue our mission to address patient unmet clinical needs globally and to accelerate the linperlisib clinical development program to bring more treatment options for patients with R/R PTCL."

In this Phase 3 study, linperlisib will be evaluated versus physicians’ choice of standard of care in R/R PTCL patients who have received one or more prior systemic therapies. The Phase 3 study will open enrollment in the U.S. and other countries.

About linperlisib
Linperlisib is a next-generation highly selective PI3Kδ inhibitor with a well-tolerated and differentiated safety profile as indicated from clinical trials in follicular lymphoma (FL), T-cell lymphoma and other hematologic and solid tumor studies. In November 2022, linperlisib was approved in China for the treatment of adult patients with R/R FL. Also in 2022, linperlisib received U.S. Food and Drug Administration (FDA) Orphan Drug Designations for FL, Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma and T-Cell Lymphoma. To date, over 6000 patients have been treated with linperlisib in clinical studies and post market approval with consistent and well-tolerated safety profile.

Linperlisib has been studied in three clinical trials in R/R PTCL in China, U.S. and Europe, with greater than 165 R/R PTCL patients treated. Collectively, these studies have demonstrated a high objective response rate, high complete response rate, promising progression free survival, overall survival, and a very manageable safety profile through the ongoing evaluations. Overall, Chinese, U.S. and European R/R PTCL patients have exhibited similar levels of efficacy and tolerability, establishing a strong foundation for a global registration trial.