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Is PD-1/VEGF dual antibody + ADC becoming the standard configuration?

The latest entrants are Kolen Biotech and Crescent. Recently, the two companies reached a unique licensing agreement, mutually introducing each other’s core pipeline assets and jointly joining the PD-1/VEGF+ADC development camp. The collaboration between Kelun Biotech and Crescent can be seen as a small and medium-sized player quickly following the lead of giants in this game. Core players such as BioNTech/BMS, 3SBio/Pfizer are laying out their strategies and competing in this field. It is not difficult to see from their clinical development strategies that the combination of PD-1(L1)/VEGF bispecific antibodies and ADCs is upgrading from “exploration” to “standard”. Just a few months ago, global pharmaceutical companies were hunting down PD-(L)1/VEGF bispecific antibodies, driving up the prices of these assets. Now, with the trend of PD-(L)1/VEGF bispecific antibodies accelerating their iteration into monoclonal antibodies confirmed, MNCs have been aggressively pursuing these acquired assets, and the “battleground” has shifted to the competition ...
- Source: drugdu
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- December 12, 2025
Another “disaster” for pre-antibody technology

Recently, Janux Therapeutics, which focuses on proantibody technology, saw its stock price plummet by 53.34% after releasing the latest clinical data for its core product JANX007. This bispecific antibody prodrug targeting PSMA/CD3 initially impressed the market with its 50% ORR (Objective Response Rate) data released in December 2024, causing the company’s stock price to surge by nearly 50% in a single day and its market capitalization to once exceed $3.5 billion. It was seen as the hope for a breakthrough in proantibody technology. However, a year later, as the sample size expanded from 16 to 104 cases, the ORR plummeted from 50% to 30%, the PSA90 response rate shrank from 63% to 26%, and the safety performance also fell short of expectations. More noteworthy is that this is not the first time the antibody field has encountered a major setback. Back in 2022, CytomX Therapeutics, a pioneer in antibody technology, ...
- Source: drugdu
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- December 12, 2025
Eding Medicines’ NexGard® showcased 11 Chinese clinical studies at APCN 2025, solidifying its position as a cornerstone of first-line treatment for IgA nephropathy

At the 23rd Asia Pacific Nephrology Congress (APCN 2025) recently, Everest Medicines’ core product, NEFECON® (budesonide enteric-coated capsules), showcased 11 of the latest clinical research data from several top hospitals in China, providing more evidence-based medical support for the treatment of IgA nephropathy. IgA nephropathy is a prevalent chronic kidney disease in Asia, with approximately 5 million patients in China and over 120,000 new diagnoses annually. This disease is characterized by high incidence and high progression rates, highlighting the urgent need for precise clinical treatment. Following the inclusion of the world’s first etiological treatment drug, Nefucon®, in my country’s national medical insurance program, clinicians have gradually shifted their focus from improving proteinuria to protecting kidney function as treatment duration accumulates, aiming to provide important insights for the long-term management of IgA nephropathy patients. The numerous studies presented at this conference, from different clinical scenarios and long-term treatment perspectives, further enriched ...
- Source: drugdu
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- December 12, 2025
Innovent Biologics’ new BCL2 inhibitor, Mesutoclax, shines with the latest clinical data at the 67th American Society of Hematology (ASH) Annual Meeting

Beijing, China, December 9, 2025 – Innovent Biologics (SSE: 688428; HKSE: 09969), a high-tech biopharmaceutical company, today announced that three studies of its novel BCL2 inhibitor, mesutoclax (ICP-248), were presented at the 67th American Society of Hematology (ASH) Annual Meeting. Mesutoclax demonstrated excellent efficacy and safety in studies treating relapsed/refractory mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and acute myeloid leukemia (AML). Studies of mesutoclax in the treatment of relapsed/refractory MCL were selected for oral presentations, and two studies of mesutoclax in the treatment of CLL/SLL and AML were selected for poster presentations. oral report Efficacy and tolerability of Mesutoclax monotherapy in patients with relapsed/refractory MCL: High response rate demonstrated in patients previously resistant to BTK inhibitors (Report No.: 887) Mesutoclax monotherapy has demonstrated excellent efficacy in treating MCL patients, particularly in previously treated patients refractory to BTK inhibitors. The overall response rate (ORR) for MCL patients ...
- Source: drugdu
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- December 12, 2025
Lilly’s Retatrutide Displays Positive Topline Results in Successful Phase III Trial

Lilly’s first Phase III results for retatrutide show unprecedented weight loss and marked reductions in osteoarthritis pain, underscoring the potential of its triple-agonist therapy to reshape treatment for obesity and related metabolic conditions. Eli Lilly and Company announced positive results from its Phase III trial study TRIUMPH-4 showing that retatrutide produced substantial weight loss and showed reductions in knee pain for adults with obesity or overweight and knee osteoarthritis. Retatrutide is a once-weekly investigational molecule that activates receptors for GIP, GLP-1, and glucagon. TRIUMPH-4, a global, randomized study, evaluated retatrutide’s two highest doses, 9 mg and 12 mg, over a 68 week period.1 In the trial, where most participants had a body mass index (BMI) of at least 23.5 lbs/ft² at baseline, both doses met all primary and key secondary endpoints, with patients receiving the 12 mg dose losing an average of 28.7% of their body weight, more than 70 ...
- Source: drugdu
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- December 12, 2025
FDA Reviewing RSV Drugs for Infants, Though No Safety Issues Found

THURSDAY, Dec. 11, 2025 (HealthDay News) — Federal regulators have begun a safety review of two RSV medicines used to protect infants, even though no safety problems have been reported. The review covers Beyfortus (from Sanofi and AstraZeneca) and Enflonsia (from Merck), both monoclonal antibodies that help shield babies from respiratory syncytial virus, or RSV. The move comes as several immunizations have faced new scrutiny under U.S. Health Secretary Robert F. Kennedy Jr. The U.S. Food and Drug Administration (FDA) said it is taking a close look at all available data, as it does with any approved product. The agency is “rigorously reviewing the available data, as it does for all products, to ensure decisions remain rooted in evidence-based science and in the best interest of patients,” HHS spokesperson Andrew Nixon said. Drugmakers say the treatments have strong safety records. Sanofi told NBC News that Beyfortus has been studied in ...
- Source: drugdu
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- December 12, 2025
【EXPERT Q&A】How does the FDA of the United States classify medical devices?

Drugdu.com expert’s response: The U.S. Food and Drug Administration (FDA) classifies medical devices into three categories—Class I (low-risk), Class II (medium-risk), and Class III (high-risk)—based on their risk levels, and implements differentiated regulatory requirements for each category. Below is a detailed explanation of the classification logic and regulatory framework: I. Classification Basis: Risk Level and Regulatory Control The FDA’s classification system is grounded in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Medical Device Amendments (MDA), with the core principle that higher risk warrants stricter regulation. Specific classification criteria are as follows: Class I (Low-Risk) Risk Characteristics: Non-invasive, non-life-supporting, with minimal potential harm to the human body. Regulatory Requirements: Implementation of General Controls, including prohibiting the sale of non-compliant products, reporting adverse events, and restricting sales scope. Approximately 93% of Class I devices are exempt from 510(k) submissions, requiring only Enterprise Registration and Product Listing. A minority of Class I devices (e.g., medical gloves, surgical ...
- Source: drugdu
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- December 12, 2025
U.S. ERs Are Failing Sickle Cell Patients In Pain, Study Says

By Dennis Thompson HealthDay ReporterWEDNESDAY, Dec. 10, 2025 (HealthDay News) — U.S. emergency rooms are failing patients in severe pain from a sickle cell disease crisis, a new study says. Only 1 in 3 patients in an ER for sickle cell crisis receive opioid painkillers within the first hour as treatment guidelines recommend, researchers reported Saturday in Orlando at an American Society of Hematology meeting. Adults, in particular, wound up experiencing prolonged suffering while waiting to receive opioids as recommended, researchers found. “One of the challenges of identifying sickle cell disease pain is that there is no biomarker for it, and as a provider, you rely on what the patient tells you about how severe the pain is,” lead researcher Dr. Ibrahim Gwarzo said in a news release. “Providers are more likely to be hesitant to administer opioids for the adult population than for little kids,” said Gwarzo, a research ...
- Source: drugdu
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- December 11, 2025
GLP-1 Medications Show Little Effect on Cancer, Study Shows

WEDNESDAY, Dec. 10, 2025 (HealthDay News) — A new study suggests popular GLP-1 drugs, like Ozempic and Zepbound, may not lower cancer risk as some had hoped. Researchers analyzed 48 randomized trials including 94,245 adults who were overweight, obese or had type 2 diabetes. More than 51,000 people took a GLP-1 drug, and nearly 43,000 received a placebo and were followed for about 70 weeks. The team wanted to know whether these medications change someone’s risk of developing any of the 13 cancers linked to obesity. The results showed GLP-1 drugs had little to no effect on the risk of cancers such as breast, thyroid, pancreatic or kidney cancer. “It’s not that GLP-1 does not reduce the risk of cancer; I don’t think we can make that conclusion from our study,” study co-author Dr. Cho-Han Chiang, a medical oncology fellow at Northwell Health Cancer Institute, told NBC News. “I would ...
- Source: drugdu
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- December 11, 2025
Qilu Pharmaceutical wins blockbuster new drug

Recently, Qilu Pharmaceutical’s pertumumab N01 injection (QL1203) was approved for marketing, for use in combination with FOLFOX as first-line treatment for patients with RAS wild-type (KRAS and NRAS are both wild-type) metastatic colorectal cancer (mCRC) , under the brand name Ankeze. This drug is classified as a Class 3.4 new drug. The original panitumumab (trade name Vectibix) is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), developed by Takeda in collaboration with Amgen, and has not yet been approved for marketing in China. Epidermal growth factor receptor (EGFR) is currently the most representative targeted therapy target for colorectal cancer treatment. In colorectal cancer, EGFR is often overexpressed, and its high expression is closely related to poor prognosis. EGFR activation can inhibit apoptosis, promote invasion and angiogenesis, ultimately leading to tumor growth. Panitumab has a high affinity for the extracellular portion of the EFGR protein and can competitively bind ...
- Source: drugdu
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- December 11, 2025

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