PharmaFocus Today – Page 25 – media

Subsidiary’s Class 1 Innovative Chemical Drug HW221043 Tablets Approved for Clinical Trials

On January 5, ST Humanwell (600079) announced that its wholly-owned subsidiary, Hubei Bio-pharmaceutical Industrial Technology Research Institute Co., Ltd., has received approval to conduct clinical trials for HW221043 Tablets in patients with advanced solid tumors. HW221043 Tablets are classified as a Class 1 chemical drug intended for the treatment of advanced solid tumors. As a New Molecular Entity (NME) independently developed by the company, there are currently no similar drugs approved for marketing either domestically or internationally. To date, the cumulative R&D investment for HW221043 Tablets totals approximately 24 million RMB. In the first three quarters of 2025, ST Humanwell reported a revenue of 17.883 billion RMB and a net profit attributable to the parent company of 1.689 billion RMB. https://finance.eastmoney.com/a/202601053608841348.html
- Source: drugdu
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- January 6, 2026
Eharmony Pharma Secures Nearly RMB 100 Million in Series B Funding to Develop Innovative Inhalable Weight-Loss Drugs

Recently, Eharmony Pharma announced the completion of its nearly RMB 100 million Series B financing round. This round was led by Beijing Medical and Health Industry Investment Fund, with participation from follow-on investors including Sanze Ventures and other institutions. The funds will be focused on three core strategic areas: advancing clinical development of key pipeline candidates, building a world-leading peptide inhalable delivery platform, and accelerating the global layout of innovative products. These initiatives will comprehensively consolidate the company’s end-to-end competitive advantages in the field of dry powder inhaler (DPI) drug delivery. Eharmony Pharma is a high-tech enterprise specialized in “drug-device combination dry powder inhaler (DPI) delivery innovation”, integrating research and development (R&D), manufacturing, and sales. The company primarily focuses on the development of dry powder inhalable formulations for respiratory and cardio-cerebrovascular diseases, having established an integrated closed-loop system covering laboratory technology, industrial-scale production, and commercialization. The successful closing of ...
- Source: drugdu
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- January 5, 2026
The first domestically produced targeted drug for thyroid eye disease has been launched, with a price reduction of up to 60%.

The new version of the National Medical Insurance Drug Catalog will officially take effect on January 1, 2026. It is understood that Innovent Biologics’ innovative drug for the treatment of thyroid eye disease…The first prescription for Tetumumab N01 injection (Symbim) after it was included in medical insurance was issued nationwide by the team of Academician Fan Xianqun from the Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine. This drug is the first domestically produced targeted therapy for thyroid eye disease in 70 years. Thyroid eye disease is a common orbital disease affecting over 4 million people in China, often leading to protruding eyeballs and vision impairment. Previously, effective treatments were limited. Tetumumab is China’s first and only targeted therapy covered by medical insurance that can reverse protruding eyeballs, achieving a response rate of 85.8% and an overall ocular efficacy of 94.2%. With inclusion in medical insurance, ...
- Source: drugdu
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- January 5, 2026
First shipment of Zantinib (Saint Hertu®) arrives! A new era of precision-targeted therapy for HER2-mutant advanced NSCLC begins.

On January 4th, the first batch of Zonaitinib tablets (Shenghetu®), jointly promoted by Boehringer Ingelheim and China Biopharmaceutical (1177.HK), arrived in China and will be put into clinical use in Guangzhou, Shanghai, and other regions as soon as possible. As the world’s first and currently only oral targeted drug approved in China for the treatment of HER2-mutant advanced non-small cell lung cancer (NSCLC), Zonaitinib provides patients with a highly effective, safe, targeted, and oral new treatment option, officially ushering in a new era of highly selective oral targeted therapy for the treatment of HER2-mutant advanced NSCLC in China. In August 2025, Zonaitinib received formal approval from the China National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy. Notably, Zonaitinib took only one ...
- Source: drugdu
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- January 5, 2026
Clinical trial application for new drug targeting integrin β6 ADC approved

Kelun Pharmaceutical (002422.SZ) announced that its subsidiary, Kelun Biotech , has received approval from the Center for Drug Evaluation of the National Medical Products Administration of China for its clinical trial application for SKB105 (also known as CR-003), an antibody-drug conjugate targeting integrin β6 (ITGB6) , for the treatment of advanced solid tumors.In addition, in December 2025, Kelun Biotech and Crescent Biopharma entered into a strategic collaboration on SKB105/CR-003 and SKB118 (PD-1 x VEGF bispecific antibody, also known as CR-001). Kelun Biotech granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside Greater China. Crescent granted Kelun Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China. Kelun Biotech plans to submit an IND application for SKB118/CR-001 in the near future. SKB105 is a differentiated ADC targeting ITGB6, using a topoisomerase 1 inhibitor as its payload. ...
- Source: drugdu
- 104
- January 5, 2026
With a transaction volume exceeding $37.3 billion, psychotropic drugs have reached a “new level.”

In the global pharmaceutical landscape, the development of drugs for schizophrenia presents a paradoxical scene: it is both a “valley of death” where giants stumble and a frontier where capital pours in. In recent years, with breakthroughs in drugs with novel mechanisms of action, the sector has seen transaction volumes exceed $37.3 billion , propelling schizophrenia drugs to new heights! 01 Development and Competitive Landscape of Psychosomatic Drugs The schizophrenia market is a crucial component of the CNS (Chemical, Neuro, and Social Sciences) field, but its research and clinical translation face severe challenges. The success rate of new drugs in this area obtaining FDA approval is only about 6%, making it a veritable “valley of death” in pharmaceutical R&D. According to Expert Market Research, the antipsychotic drug market is projected to reach nearly $20 billion in 2024. This market size reflects the concentrated demand for medication from a long-term patient ...
- Source: drugdu
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- January 5, 2026
Sacituzumab Tirumotecan (TROP2 ADC) in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Locally Advanced or Metastatic NSCLC Granted Breakthrough Therapy Designation by NMPA

People’s Fortune News, Jan 5 — Sichuan Kelun Pharmaceutical (002422.SZ) announced on the morning of January 5 that its holding subsidiary, Kelun-Biotech, has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its TROP2-targeted antibody-drug conjugate (ADC), Sacituzumab Tirumotecan (sac-TMT, also known as SKB264/MK-2870; brand name: Jiatailai®). The designation applies to the combination of sac-TMT and MSD’s anti-PD-1 monoclonal antibody, Pembrolizumab (Keytruda®), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have a PD-L1 tumor proportion score (TPS) ≥1% and are negative for EGFR mutations and ALK rearrangements. Additionally, Kelun-Biotech’s self-developed integrin β6 (ITGB6)-targeted ADC, SKB105 (also known as CR-003), has received Investigational New Drug (IND) approval from the CDE for clinical trials in the treatment of advanced solid tumors. https://finance.eastmoney.com/a/202601053608098625.html
- Source: drugdu
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- January 5, 2026
Insilico Medicine and Hisun Pharmaceutical Collaborate to Nominate Preclinical Candidate Compound in Just 8 Months

Insilico Medicine Achieves Key Milestone in Collaboration with Hisun Pharmaceutical: Preclinical Candidate Compound Nominated in Just 8 MonthsJanuary 2, 2026 Insilico Medicine (03696.HK), a clinical-stage biotech company pioneering generative AI-driven drug discovery, announced a significant milestone in its collaborative project with Hisun Pharmaceutical (600267.SH) on January 2, 2026. Leveraging its proprietary AI platform Pharma.AI, Insilico Medicine efficiently nominated a Preclinical Candidate Compound (PCC) for the joint program merely eight months after the strategic partnership was established. The collaboration was initiated in April 2025, when Xiao Weihong, Chairman and President of Hisun Pharmaceutical, and Ren Feng, Co-CEO and Chief Scientific Officer of Insilico Medicine, signed a strategic cooperation agreement for innovative drug R&D at Hisun Pharmaceutical’s R&D headquarters. Under the agreement, the two parties agreed to leverage their respective strengths to jointly conduct AI-driven innovative drug discovery for selected targets in specific indication areas. Specifically, Insilico Medicine is responsible for early-stage ...
- Source: drugdu
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- January 4, 2026
Zelgen Biopharma’s Drug-in-Development Sold for Over $1.2 Billion

Cailian Press, December 31 (Reporter: Wu Chao) – Another Chinese pharmaceutical firm has secured a major overseas Business Development (BD) deal exceeding $1 billion for a DLL3-targeted drug. Zelgen Biopharma (688266.SH) has reached an agreement with a global pharmaceutical giant for the worldwide development and commercialization of its core pipeline product, ZG006 (Alveltamig), with a potential total value surpassing $1.2 billion. Zelgen Biopharma announced this evening that it has entered into a strategic collaboration and license option agreement with a holding company of the AbbVie Group (registered in Bermuda, hereinafter “AbbVie”) regarding ZG006. Under the terms, AbbVie will obtain exclusive rights to develop and commercialize ZG006 outside of Greater China (including Mainland China, Hong Kong, Macau, and Taiwan), while Zelgen retains all rights within the Greater China region. According to the agreement, Zelgen will receive an upfront payment of $100 million, plus near-term clinical milestone payments and license-option-related payments of ...
- Source: drugdu
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- January 4, 2026
Rongchang Bio’s “Vidicituzumab” is proposed to be included in the Breakthrough Therapy list for a new indication

On December 31, the CDE website showed that Rongchang Bio’s vidicetuzumab is proposed to be included in the Breakthrough Therapy list for a new indication, in combination with trastuzumab and toripalimab as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma with high HER2 expression . Vidicetumab has been included in the Breakthrough Therapy designation three times before . If it passes the public announcement this time, it will become the drug’s fourth Breakthrough Therapy designation . Vidicetumab is a HER2-targeted ADC drug developed by Rongchang Biotechnology. Through a “precision burst” mechanism, it can not only kill HER2-highly expressing tumor cells, but also attack neighboring HER2-low-expressing cells through the “bystander effect.” Since its initial approval in 2021, this product has been approved for three indications : HER2-overexpressing locally advanced or metastatic gastric cancer that has received at least two types of systemic chemotherapy ; Patients with previously received systemic chemotherapy and HER2-overexpressing ...
- Source: drugdu
- 102
- January 4, 2026

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