PharmaFocus Today – Page 76 – media

Immunocompromised people are susceptible to skin cancer caused directly by beta-HPV

Researchers at the National Institutes of Health (NIH) have shown for the first time that a type of human papillomavirus (HPV) commonly found on the skin can directly cause a form of skin cancer called cutaneous squamous cell carcinoma (cSCC) when certain immune cells malfunction. cSCC is one of the most common cancers in the United States and worldwide. Previously, scientists believed HPV merely facilitated the accumulation of DNA mutations caused by ultraviolet (UV) radiation, usually the primary driver of cSCC. The findings were published today in The New England Journal of Medicine. This discovery could completely change how we think about the development, and consequently the treatment, of cSCC in people who have a health condition that compromises immune function. It suggests that there may be more people out there with aggressive forms of cSCC who have an underlying immune defect and could benefit from treatments targeting the immune ...
- Source: drugdu
- 131
- August 1, 2025
Blood-Based Colon Cancer Tests Work, But Many Patients Skip Follow-Up

By Ernie Mundell HealthDay ReporterWEDNESDAY, July 30, 2025 (HealthDay News) — You try one of the new blood-based tests for colon cancer, and unfortunately, the results come back “abnormal.” Those are alarming findings, of course. But for too many U.S. patients, no further steps are taken, a new study finds. “Blood-based colorectal cancer screening is promising, but it only works if individuals complete the follow-up colonoscopy,” said study senior author Dr. Folasade May. “More efforts are needed to help patients follow through to actually diagnose and treat the disease,” said May, an associate professor of medicine at the David Geffen School of Medicine at UCLA. Colorectal cancer remains the second-leading cancer killer, with 52,900 related deaths expected during 2025, according to the American Cancer Society. Luckily, there are ways to spot the disease early, when it is most preventable. These include colonoscopy (recommended start time is age 45 for people ...
- Source: drugdu
- 171
- August 1, 2025
Zhaoke Ophthalmology’s Melphalan Receives FDA Orphan Drug Designation

On July 30, Zhaoke Ophthalmology (06622) issued an announcement, announcing that its melphalan drug has been granted orphan drug certification by the U.S. Food and Drug Administration (FDA) for the treatment of retinoblastoma in children. This certification lays the regulatory foundation for the company to submit an IND application in the U.S. If melphalan is successfully developed and approved, the company will enjoy seven years of exclusive U.S. market rights after the IND application, protecting both marketing authorization holder status and data exclusivity. Retinoblastoma is a rare eye cancer that primarily affects children under five years old. It affects approximately 200 to 300 cases annually in the United States and approximately 1 in every 15,000 to 18,000 live births worldwide. While the company cannot guarantee the success of the development or commercialization of melphalan, the announcement advises shareholders and potential investors to exercise caution when trading the company’s shares. Source：https://finance.eastmoney.com/a/202507303471632174.html
- Source: drugdu
- 171
- July 31, 2025
Jiuzhou Pharmaceutical’s antidiabetic drug dapagliflozin API approved for registration

On July 29, Jiuzhou PharmaceuticalThe announcement stated that it had received the ” Chemical Raw Materials” issued by the State Food and Drug Administration regarding dapagliflozin.The company has received a “Notice of Approval of the Drug Marketing Application” (Notification No. 2025YS00631), confirming that the dapagliflozin API meets the relevant drug registration requirements and formally approved its registration. This will further enrich the company’s product portfolio and enhance its market competitiveness. Dapagliflozin tablets are an important hypoglycemic drug, primarily used to treat adult patients with type 2 diabetes, and are widely used clinically. The announcement indicates that in the first half of 2024, domestic sales of dapagliflozin tablets reached approximately 3.338 billion yuan. As of the date of the announcement, Jiuzhou Pharmaceutical has invested approximately 5.05 million yuan in the research and development of dapagliflozin. Currently, major domestic manufacturers of dapagliflozin APIs include CSPC Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. and ...
- Source: drugdu
- 179
- July 31, 2025
A new breakthrough in the multi-billion dollar influenza market! Domestically produced Maseloxavir tablets approved for marketing

Recently, the National Medical Products Administration officially approved the marketing of the Class 1 innovative drug Maseloxavir Tablets (trade name: Jikeshu) submitted by Nanjing Zhengxiang Pharmaceutical Co., Ltd. It is suitable for previously healthy adult patients with simple influenza A and B (excluding those at high risk of complications). Influenza A and B viruses are seasonally prevalent every year, among which influenza A virus can cause a global pandemic. China’s anti-influenza drug industry is growing rapidly. According to Yaozhi Data [Drug Full Terminal Sales Analysis System], in 2023, my country’s anti-influenza drug sales in the country’s three major terminals (public hospitals + retail pharmacies + e-commerce B2C) will exceed 20 billion yuan. In such a huge market context, Maseloxavir tablets will cause a huge sensation. Maseloxavir tablets are a new-generation, globally proprietary inhibitor targeting the influenza virus RNA polymerase (PA) enzyme. They have rapidly gained recognition for their proven efficacy, ...
- Source: drugdu
- 352
- July 31, 2025
New therapy breaks the deadlock in treating the “king of gynecological cancer”

Recently, Tongyi Pharmaceutical’s first dual-ligand small drug conjugate CBP-1008 (Rico-V, Ruikefutai) received approval from the NMPA to conduct a Phase III clinical trial in platinum-resistant ovarian cancer (PROC registration). The drug is reportedly a fully chemically synthesized, small bi-ligand drug conjugate (Bi-XDC) with a molecular weight approximately 1/50 of that of traditional ADCs, offering unique advantages in terms of CMC and cost. Rico-V has been approved for Phase III clinical trials and is expected to become the world’s first Bi-XDC drug, offering a new treatment option for ovarian cancer patients. New therapy breaks the deadlock in treating the “king of gynecological cancer” Ovarian cancer ranks first in mortality among gynecological malignancies, earning it the nickname “the king of gynecological cancers.” Because it lacks specific early symptoms and is often diagnosed in its advanced stages, it’s also known as the “silent killer.” According to statistics from the National Cancer Center in ...
- Source: drugdu
- 303
- July 31, 2025
Autoantibodies Influence Cancer Response To Immunotherapy, Study Says

By Dennis Thompson HealthDay ReporterMONDAY, July 28, 2025 (HealthDay News) — Cutting-edge immunotherapy drugs are incredibly effective against some cancers but barely put a dent in others – and researchers might now know why. Patients’ own autoantibodies – immune proteins traditionally associated with autoimmune diseases like psoriasis and lupus – appear to dramatically influence their individual response to immunotherapies, researchers report in the journal Nature. “Our analysis shows that certain naturally occurring autoantibodies can tilt the odds dramatically toward shrinking tumors,” senior researcher Dr. Aaron Ring, chair of immunotherapy at Fred Hutchinson Cancer Center in Seattle, said in a news release. “We saw some cases where autoantibodies boosted a patient’s likelihood of responding to checkpoint blockade by as much as five- to ten-fold,” he said. The study focused on immune checkpoint inhibitors, drugs that boost the body’s ability to attack on cancer by removing cancer cells’ ability to evade detection ...
- Source: drugdu
- 168
- July 31, 2025
FDA Grants Priority Review, Breakthrough Therapy Designation to AstraZeneca’s Imfinzi for Gastric, Gastroesophageal Junction Cancers

Source: Pharmaceutical Executive The FDA has granted Priority Review and Breakthrough Therapy Designation for Imfinzi (durvalumab) in patients with resectable, early-stage, and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. According to the company, these designations were based on results from the Phase III MATTERHORN trial (NCT04592913), which demonstrated that a perioperative Imfinzi-based regimen, administered before and after surgery alongside chemotherapy, significantly reduced the risk of disease progression, recurrence, or death compared to chemotherapy alone.1 How Could the MATTERHORN Trial Results for Imfinzi Change the Treatment Paradigm for Early-Stage Gastric and GEJ Cancers? “This Priority Review reinforces the potential for a perioperative approach with Imfinzi to transform care for patients with early gastric and gastroesophageal junction cancers, who frequently face disease recurrence or progression even after curative-intent surgery and perioperative chemotherapy,” said Susan Galbraith, EVP, oncology hematology R&D, AstraZeneca, in a press release. MATTERHORN Trial Design ...
- Source: drugdu
- 153
- July 31, 2025
Lenacapavir “zero time difference” landing in Lecheng, China’s HIV prevention and control enters a new era of long-term prevention

On July 25, 2025, Lenacapavir, the world’s first pre exposure preventive drug against HIV that only needs to be administered twice a year, was officially launched in Hainan Boao Lecheng International Medical Tourism Pioneer Zone. This innovative drug with a breakthrough mechanism and long-term protection capability has realized the synchronous accessibility of almost “zero time difference” with the world, provided a new weapon for ending the AIDS epidemic goal, and is expected to further enhance the diversification process of China’s HIV prevention and control pattern. We have reached a real turning point in the journey of HIV prevention and control. Professor Zhang Fujie from Beijing Ditan Hospital affiliated with Capital Medical University introduced that Lenacapavir is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, suitable for pre exposure prophylaxis (PrEP) in adults at risk of HIV-1 infection and adolescents weighing not less than 35 kg to reduce the risk ...
- Source: drugdu
- 295
- July 30, 2025
Reaches innovative drug overseas authorization agreement with GlaxoSmithKline, with potential revenue exceeding $12 billion

On the morning of July 28, CSI Smart Finance Hengrui Pharmaceutical (600276) announced that the company had reached an agreement with GlaxoSmithKline (GSK) to grant GSK the exclusive global rights of the HRS-9821 project outside Chinese Mainland, Hong Kong, Macao and Taiwan, as well as the exclusive global options for up to 11 projects. HRS-9821 is a potential best in class PDE3/4 inhibitor currently in clinical development, which can be used to treat chronic obstructive pulmonary disease (COPD) as an adjuvant maintenance therapy without considering previous treatment plans. The drug has shown potent PDE3 and PDE4 inhibitory effects in early clinical and preclinical studies, enhancing bronchodilation and anti-inflammatory effects, and providing opportunities for the development of convenient dry powder inhaler (DPI) formulations. The other 11 projects involve innovative drugs in multiple therapeutic fields such as cancer, respiratory, autoimmune, and inflammation, all of which are currently in the non clinical research ...
- Source: drugdu
- 213
- July 30, 2025

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