PharmaFocus Today – Page 8 – media

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
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- 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
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- 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
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- 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
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- July 30, 2025
Biopharma subsidiary obtains clinical approval for feline infectious peritonitis mRNA vaccine

On July 26, Bio-TechnologyAn announcement was issued stating that its wholly-owned subsidiary Jinyu Baoling Biopharmaceutical Co., Ltd. (referred to as “Jinyu Baoling”), in conjunction with Beijing Hesheng Gene Technology Co., Ltd., has obtained the clinical trial approval certificate for feline infectious peritonitis mRNA vaccine issued by the Ministry of Agriculture and Rural Affairs (approval number: 2025062), becoming the first company in China to obtain a clinical approval certificate for this type of veterinary nucleic acid vaccine. It is understood that feline infectious peritonitis is caused by feline infectious peritonitis virus (FIPV), which is a highly contagious disease with a mortality rate of up to 100%. Currently, there is no commercial vaccine in the world. The vaccine approved this time adopts the mRNA technology route, integrating AI algorithms and structural biology during the research and development process .A large number of animal experiments were conducted to screen out core targets for ...
- Source: drugdu
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- July 30, 2025
Ambroxol hydrochloride drops converted to over-the-counter drugs

July 25, the State Food and Drug Administration issued an announcement on the conversion of prescription drugs of Ambroxol Hydrochloride Drops to over-the-counter drugs. According to the provisions of the “Regulations on the Classification and Management of Prescription Drugs and Over-the-counter Drugs (Trial)” (Order No. 10 of the former State Food and Drug Administration), after the demonstration and review organized by the State Food and Drug Administration, Ambroxol Hydrochloride Drops was converted from a prescription drug to an over-the-counter drug. Source：https://finance.eastmoney.com/a/202507253467955429.html
- Source: drugdu
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- July 30, 2025
A new autoimmune drug in China has successfully completed Phase III, outperforming Cosentyx head-to-hea.

Recently, Joincare Pharmaceutical Group Industry Co., Ltd. issued an announcement stating that the Phase III clinical trial of “Recombinant Humanized Anti-Human IL-17A/F Monoclonal Antibody Injection” (LZM012), jointly developed by Livzon Monoclonal Antibody, a controlled subsidiary of Livzon Pharmaceutical Group (itself a controlled subsidiary of Joincare), and Beijing Xinkanghe Biomedical Technology Co., Ltd., had reached its primary study endpoint. According to the announcement, this Phase III clinical study was a multicenter, randomized, double-blind, active-controlled (secukinumab) trial conducted among patients with moderate-to-severe plaque psoriasis. The primary endpoint was the proportion of subjects achieving a 100% reduction in the Psoriasis Area and Severity Index (PASI 100 response rate) at Week 12. The study results demonstrated that the primary efficacy endpoint was met. The PASI 100 response rate at Week 12 was 49.5% for LZM012, compared to 40.2% for the control group (secukinumab), indicating that LZM012 was non-inferior and superior to secukinumab. For the ...
- Source: drugdu
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- July 30, 2025
Johnson & Johnson has submitted an application to the FDA for its new drug, challenging AbbVie’s position as the leading player in autoimmune diseases.

Recently, Johnson & Johnson (J&J) submitted a marketing application to the U.S. Food and Drug Administration (FDA) for Icotrokinra (JNJ-2113), the world’s first oral interleukin-23 (IL-23) receptor antagonist. This new drug, designed to liberate patients with moderate-to-severe plaque psoriasis from injections, not only carries the hopes of millions of patients longing to “bid farewell to needles” but is also seen as a pivotal move by J&J to revitalize its dominance in autoimmune diseases and challenge the throne of its long-time rival, AbbVie. In the field of pharmaceutical R&D, the development of oral peptide drugs was once considered an “impossible mission.” The successful breakthrough of Icotrokinra represents a technological “barrier-breaking” achievement. Its four pivotal Phase III clinical trials have yielded impressive data: the drug not only demonstrates robust overall efficacy but also shows significant advantages in traditionally challenging areas such as the scalp and genital regions. The convenience of taking one ...
- Source: drugdu
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- July 30, 2025
Aidea Pharmaceuticals’ innovative drugs are approved for listing in Zanzibar

Chinese MedicineInnovation power has ushered in a historic breakthrough in Africa. On July 25, 2025, Jiangsu Aidea PharmaceuticalThe innovative anti-HIV drug independently developed by Aidea PharmaceuticalsThe New Drug Application (NDA) of Fubond® (generic name: Enomitid tablets) has been officially approved by the Zanzibar Food and Drug Administration (ZFDA). This not only marks the successful launch of Aidea Pharmaceuticals’ first innovative drug , but also means that China’s independently developed new anti-AIDS drug has taken root in Africa for the first time, setting a key milestone for China’s pharmaceutical industry to participate in solving major global public health challenges. Focusing on Africa’s urgent needs, the Chinese solution is moving forward. Africa bears the arduous challenge of the global fight against AIDS. According to statistics, about 70% of the world’s AIDS patients (more than 26 million people) live on this continent. The approval of Fubond® in Zanzibar (a part of the United ...
- Source: drugdu
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- July 29, 2025
Ascletis Pharma ASC30 has completed dosing of the first batch of obese or overweight subjects

On July 28, Ascletis Pharmaceuticals-B (01672) issued an announcement, announcing that the first batch of obese or overweight subjects have been dosed in the 12-week Phase IIa study of its small molecule GLP-1R agonist ASC30 once-monthly subcutaneous reservoir formulation in the United States. The study targets obese people or overweight people with at least one weight-related comorbidity. Preliminary results show that the half-life of ASC30 is as long as 36 days, supporting the once-monthly dosing regimen. The results of the Phase Ib study showed that compared with the trough concentration of ASC30 on the 29th day, the peak-to-trough ratio of the blood drug concentration of this ultra-long-acting subcutaneous reservoir formulation was less than 2:1, meeting the requirements of good tolerability. The company expects to obtain top-line data from a 12-week Phase IIa study of ASC30’s monthly subcutaneous depot formulation in the first quarter of 2026. ASC30 is the first small ...
- Source: drugdu
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- July 29, 2025

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