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Is Drug Working? Still Needed?

A new allergy medication is prompting clinicians to adjust their approach to oral food challenges — medically supervised tests in which clinicians give increasing doses of an allergen like peanut or milk to see how a patient reacts. The FDA in 2024 approved omalizumab (Xolair) to help reduce allergic reactions in adults and children aged 1 year or older with immunoglobulin E-mediated food allergy. Patients receiving the injections are supposed to avoid foods to which they are allergic. In the event of an accidental exposure, the medication can afford protection against a serious reaction. The approval opened a new frontier in allergy therapy but also raised questions without clear answers, like: How can patients be sure the medication is working? And how will they know if they “outgrow” an allergy, as some people do? After the approval, clinicians wrote to the American Academy of Allergy, Asthma & Immunology seeking advice. ...
- Source: drugdu
- 30
- July 14, 2025
FDA Grants Orphan Drug Designation to Adcentrx Therapeutics’ ADRX-0405 STEAP1 ADC

Adcentrx Therapeutics, a clinical-stage biotechnology company developing antibody-drug conjugate (ADC) therapies for cancer treatments and other life-threatening diseases, announced on July 8, 2025, that FDA has granted orphan drug designation to ADRX-0405, Adcentrx’s treatment of patients with gastric cancer. “Receiving orphan drug designation from FDA is a notable milestone for Adcentrx and reinforces the potential for ADRX-0405 to improve the lives of patients with gastric cancer,” said Hui Li, Ph.D., founder and chief executive officer of Adcentrx. “We are encouraged by the progress of our Phase 1a trial and look forward to further evaluating the safety, tolerability and anti-tumor activity of ADRX-0405 in gastric and other cancer.”1 ADRX-0405 is currently under evaluation in Phase 1a of Phase 1a/b clinical trials for treatment of select advanced solid tumors such as metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer. This is a 2-part study. Phase 1a will consist ...
- Source: drugdu
- 29
- July 14, 2025
KYS2301 gel approved for clinical use in atopic dermatitis

Kangyuan Pharmaceutical announced that the company recently received the “Drug Clinical Trial Approval Notice” for the Class 1 chemical new drug KYS2301 gel (three specifications) issued by the National Medical Products Administration. KYS2301 gel is the world’s first peptide inhibitor targeting the CCR8 target, and its indication is atopic dermatitis. Preclinical studies have shown that KYS2301 has a high affinity for the CCR8 target, and topical application of KYS2301 gel has a good pharmacodynamic effect on the treatment of atopic dermatitis. Toxicology and pharmacokinetic studies have shown that KYS2301 gel is highly safe. At present, the treatment drugs for atopic dermatitis mainly include topical corticosteroids, which have many adverse reactions and are not suitable for long-term use. The development of localized atopic dermatitis treatment drugs with better safety has important clinical significance. https://www.nbd.com.cn/articles/2025-07-03/3932088.html
- Source: drugdu
- 27
- July 14, 2025
Innovent Biologics’ Enzeshu was approved for marketing, becoming China’s first targeted drug for all patients with platinum-resistant ovarian cancer

Recently , Innovent’s innovative drug subsidiary, Innovent, announced that its new generation of anti-angiogenesis (anti-VEGF antibody) first-class biological new drug Enzeshu (generic name: Suvicitamab for injection) developed in China has been officially approved for marketing by the China National Medical Products Administration. Enzeshu is approved for the treatment of recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer in adults who have received no more than one systemic treatment after platinum resistance in combination with paclitaxel, liposome doxorubicin or topotecan. It is reported that Enzeshu is the first targeted drug in my country to obtain indications for the entire population of platinum-resistant ovarian cancer, breaking the dilemma of limited treatment options in this field. In recent years, the innovative transformation of the old pharmaceutical company Innovent Biologics has begun to show results. The company currently has 10 innovative drugs on the market, and 8 of them have been approved ...
- Source: drugdu
- 26
- July 14, 2025
CStone Pharmaceuticals and Istituto Gentili Enter into European Commercialization Collaboration

Recently , CStone Pharmaceuticals announced that it has reached an exclusive strategic cooperation with Istituto Gentili (hereinafter referred to as Gentili) on the commercialization of Sugemalimab in Western Europe and the United Kingdom. Gentili has obtained the exclusive commercialization rights of Sugemalimab in 23 countries, and CStone Pharmaceuticals will receive a payment of up to US$192.5 million, including an initial payment, registration and sales milestone payments, and a revenue share of nearly 50% of the net sales of Sugemalimab in the authorized area. This cooperation shows that CStone Pharmaceuticals’ products have been recognized in the international market, which will help enhance its influence in the field of global cancer treatment. In the long run, this cooperation will enhance investors’ confidence in the company’s future growth and lay the foundation for the company to further expand its overseas market. https://www.nbd.com.cn/articles/2025-07-08/3936641.html
- Source: drugdu
- 26
- July 14, 2025
The rise of PD-1/VEGF triple antibodies

With Kangfang Biopharma’s successful challenge to PD-1 monoclonal antibody with Ivoside, tumor immunotherapy (IO) has rapidly evolved to the 2.0 era. PD-(L)1/VEGF bispecific antibodies have been snapped up by MNCs, and PD-(L)1/VEGF trispecific antibodies have gradually become a research and development trend, indicating that tumor treatment is accelerating towards multi-target synergy. Recently, CStone Pharmaceuticals announced the latest clinical progress of its independently developed potential first-in-class/best-in-class CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody). The drug has balanced monovalent PD-1 and CTLA-4 binding arms and bivalent VEGFA binding arms, which can produce strong multi-target synergistic effects and preferentially target tumor tissues to reduce systemic toxicity. The global multi-center Phase I/II clinical study of CS2009 is actively recruiting patients in Australia and China, and plans to expand to the United States for Phase II enrollment. Currently, the trial enrollment is very rapid, and the number of patients is expected to exceed 100 by the end of ...
- Source: drugdu
- 25
- July 14, 2025
The leading domestic pharmaceutical company for general cell therapy of Parkinson’s disease has obtained tens of millions of yuan in market-based financing within a few months!

According to industrial and commercial information, in May 2025, Roche Biopharmaceuticals (Suzhou/Shanghai) Co., Ltd. (Roche Accelerator Member) has completed a new round of market-oriented financing . The new financing came from Jianfa Emerging Investment, Suzhou Angel Fund, Xinxi Capital, and Qisheng Capital. Just a few months ago, in October 2024, Shize Bio officially announced the completion of more than 100 million yuan in B1 round of market-oriented financing : the B1 round of financing was led by Tailong/Taikun Capital, co-invested by Qisheng Capital and Tianhui Capital, and additional investments from old shareholders such as Frees Capital, Qiming Venture Partners, Lilly Asia Fund, and Sequoia China. The B1 round of financing will be used to improve Shize Bio’s clinical-grade iPS-derived cell drug pipeline for the treatment of neurological diseases, further conduct clinical research, and promote multiple registered clinical trials. During the overall downturn of the pharmaceutical industry from 2022 to 2025, ...
- Source: drugdu
- 25
- July 14, 2025
Henlius HLX43 has been approved by multiple countries to conduct an international multi-center Phase II clinical trial in NSCLC, leading the global development of PD-L1 ADC

Recently, Henlius has made another important progress in the global development of its innovative programmed death-ligand 1 (PD-L1) antibody-drug conjugate (ADC) injection HLX43. The product has been approved by the China National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to conduct an international multicenter Phase II clinical study for advanced non-small cell lung cancer (NSCLC), and the first subject has been dosed in China. No similar ADC product targeting PD-L1 has been approved for marketing in the world, and HLX43 is the world’s first PD-L1 ADC to enter Phase II clinical trials. According to the latest data from GLOBOCAN, lung cancer is the cancer with the highest morbidity and mortality in the world. In 2022, there will be more than 2.48 million new cases of lung cancer worldwide, accounting for 12.4% ...
- Source: drugdu
- 27
- July 14, 2025
A subsidiary of United Pharmaceuticals received FDA approval for clinical trials of innovative drugs

On July 10, United Pharmaceutical (03933) issued an announcement, announcing that its wholly-owned subsidiary United Biotech received approval from the U.S. FDA on July 4, 2025 to register its Class 1 innovative drugUBT37034 injection is used in clinical trials for the indication of overweight or obesity. The drug was developed by Federal Biotechnology and has independent intellectual property rights.It is a new type of peptide receptor agonist that can reduce body weight by selectively acting on neuropeptide Y2 receptors. The announcement mentioned that preclinical animal model studies of UBT37034 showed that it can significantly reduce body weight when used in combination with GLP-1 analogs. The company said it will continue to focus on new product research and development, enhance its competitiveness and creativity in the biopharmaceutical industry, and is expected to create greater benefits for the company and its shareholders. https://finance.eastmoney.com/a/202507103453263675.html
- Source: drugdu
- 34
- July 14, 2025
SINOPHARM New Drug Application Accepted

On July 10, SINOPHARM (01177) announced that the Group’s independently developed CDK2/4/6 inhibitor Cumocillin Capsules “TQB3616” combined with Fulvestrant Injection for previously untreated HR-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer has been submitted to the Center for Drug Evaluation of the China National Medical Products Administration for new indications for marketing approval and has been accepted. The approval of the first-line indication application further confirms the broad potential of this combination therapy in different treatment stages of advanced breast cancer. In addition, the new drug application for Cumosili submitted by the Group in July 2024 has also been accepted by the CDE for use in combination with Fulvestrant for the treatment of HR+/HER2- locally advanced or metastatic breast cancer that has been previously treated with endocrine therapy. The announcement mentioned that breast cancer is one of the most common malignant tumors in women, of which HR+/HER2- breast cancer ...
- Source: drugdu
- 31
- July 14, 2025

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