145 New Drug Candidates Receive IND Approval in June; 52 Granted Special Designations and Five Major BD Deals Closed
Kelun-Biotech
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Hengrui Pharma
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Clinical Trial Approvals for New Drugs in China in June
A total of 145 new drugs were approved for clinical trials in June(A total of 237 acceptance numbers), a decrease of 53 products compared to the previous month；
JuneThe new drugs with the highest number of approved clinical trial acceptance numbers are antineoplastic agents and immunomodulators, totaling 101, accounting for 65%.；
JuneThe approved dosage forms are mainly injections and tablets, with 123 and 84 respectively.。
Global Overview of Drug Candidates Granted Orphan Drug, Breakthrough Therapy, and Fast Track Designations
In June, there were a total of52The drug has been granted Orphan Drug/Breakthrough Therapy/Fast Track designation.
Latest Updates on Positive/Negative Clinical Results of Global Innovative Drugs in Development
Kelun-Biotech Announces First-in-Human Study Data for Innovative B7-H3 ADC；
Innovent Announces Phase 3 Clinical Results of Mazdutide for the Treatment of Obesity；
Hengrui Pharma Announces Phase 3 Clinical Results of Ruikang Trastuzumab for Advanced Colorectal Cancer；
Merck & Co.’s Monoclonal Antibody Meets Primary Endpoint in Phase 3 Clinical Trial for Ulcerative Colitis。
Screenshot source: PharmCube Consulting Monthly Report on Innovative Drugs
The new drugs with the highest number of clinical trial application approvals this month were antineoplastic and immunomodulatory agents, with 101 approvals, accounting for 65% of the total. Digestive system and metabolic drugs also had a relatively high number of approvals, with 18. The approved dosage forms were primarily injections and tablets, with 123 and 84 approvals, respectively.
Source: Menet Consulting Monthly Report on Innovative Drugs
In June 2026, the domestic pharmaceutical market has22 modelsNew Drug Approved for Market Launch,On June 5, public information on the official website of the National Medical Products Administration showed thatTasly Pharmaceutical GroupProposed Traditional Chinese Medicine1.1 ClassInnovative DrugsZaoren Ningxin Dripping PillsApproved for market launch.
Zaoren Ningxin Dripping Pills(Also known as: Anshen Dripping Pills, TCM0012)The prescription is derived from the clinical empirical formula of Academician Zhang Boli, a Master of Traditional Chinese Medicine. It has the effects of nourishing blood and soothing the liver to relieve irritability, as well as replenishing qi and calming the mind to tranquilize the spirit. It is used to improve insomnia characterized by intermittent sleep and awakening due to heart-liver blood deficiency syndrome in TCM differentiation, accompanied by dizziness or lightheadedness, dry and astringent eyes, a pale red tongue with a thin white coating, and a deep and thready pulse. The market launch of Zaoren Ningxin Dripping Pills provides a solution for difficulty in maintaining sleep.(Intermittent sleep)and provides new treatment options for patients with concomitant daytime functional impairment.
Source of screenshot: Global Drug R&DDatabase(Check data. Find PharmCube)
6Month9Day,Zai LabAnnounced, the National Medical Products Administration of China (NMPA) ApprovedVutrisiran for Injectionmarketing authorization application for the treatment of adult patients with recurrent or metastatic cervical cancer who have progressed during or after chemotherapy. The approval is based on a global, randomized controlled3PhaseinnovaTV 301Clinical Study Results. The study met its primary endpoint: veltistotug demonstrated an overall survival (OS) benefit compared with chemotherapy in adult patients with previously treated recurrent or metastatic cervical cancer.OS) benefit, including in the exploratory subgroup of Chinese patients.
Vutrisiranis an antibody-drug conjugate (ADC)ADC), byGenmabTargeting tissue factor (TF) humanized monoclonal antibodies and Pfizer'sADCTechnical composition: This technology utilizes a protease-cleavable linker to conjugate the microtubule-disrupting agent monomethylauristatin E（MMAE) covalently conjugated to the antibody.
New Drugs Approved for Marketing in China in June 2026
Source: Moresent Consulting Monthly Report on Innovative Drugs
Screenshot source: Minsent Consulting Innovative Drug Monthly Report
On June 1, Haisco Pharmaceutical announced that its wholly-owned subsidiary, Haisco USA, recently received marketing approval from the U.S. FDA for a Class I innovative intravenous anesthetic drug independently developed by Haisco Pharmaceutical—Ciprofol Injection(Generic English Name: Cipepofol Injection)Approved in the United States for new drug application, indicated for induction of general anesthesia in adults.
Screenshot source: Global Drug R&DDatabase(Search data. Find MedChemExpress)
For a long time, clinical pain points associated with intravenous anesthesia, such as injection pain and respiratory depression, have remained challenging issues that the global pharmaceutical research and development sector has sought to overcome. Publicly available information shows that,Ciprofol InjectionCiprofol is a novel intravenous anesthetic drug developed by Haisco Pharmaceutical. Its active ingredient, ciprofol, is a small-molecule drug with an (R)-configured isomer that acts as a GABAA receptor agonist, inhibiting the central nervous system to produce anesthetic effects. In China, the product has been approved for multiple indications, including sedation during gastrointestinal endoscopy, induction of general anesthesia, fiberoptic bronchoscopy, and sedation during intensive care. Furthermore, the approval of dosage and administration for the induction and maintenance of general anesthesia in children and adolescents has further expanded its clinical application scenarios.
Screenshot source:Moshang Consulting "Monthly Report on Global New Drugs in Development, June 2026"
On June 1, Haisco Pharmaceutical Group announced that its wholly-owned subsidiary, Haisco Pharmaceutical Technology (Lhasa) Co., Ltd., had officially signed a cooperation agreement with global pharmaceutical giant Eli Lilly on May 29. The two parties have reached a global strategic collaboration focused on innovative small-molecule drugs across multiple disease areas, with the total potential transaction value reaching up to $3.054 billion.
Pursuant to the agreement, Haisco will be responsible for drug discovery and early-stage development of up to five innovative drug projects targeting indications selected by Eli Lilly, leveraging its mature small-molecule innovation technology platform and efficient new drug development system. Eli Lilly will obtain exclusive global rights, or exclusive global rights outside Greater China, for the relevant projects, while Haisco retains exclusive rights for certain projects in mainland China, Hong Kong, Macao, and Taiwan. Financially, Haisco is eligible to receive upfront and near-term payments totaling up to USD 87 million, as well as clinical, regulatory, and commercial milestone payments of up to USD 2.967 billion. Additionally, Haisco will be entitled to tiered royalties based on net sales after product launch, bringing the total potential value of the transaction to USD 3.054 billion. JuneFor more information on popular BD transactions among enterprises, please refer to the table below:
This report is released regularly at the beginning of each month. Stay tuned.
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