Launched Overseas or Under Marketing Application Review

Global
Global
Designated Asian Regions
Designated Asian Regions
Mainland China, HK SAR, Macao SAR and Taiwan
Mainland China, Hong Kong, Macao and Taiwan
China
China
Overseas
Overseas
Product Rights Authorized Region Indication Clinical Trial Approval Clinical Trial for Registration Marketing Application Marketed Major Marketed Regions
CN US EU JP
Diazepam Nasal Spray China Intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients with epilepsy six years of age and older
Tildrakizumab Solution for Injection
(Biological Agent)
China Moderate-to-severe plaque psoriasis

(HK)

(US)

(OU)

(JAP)
Methotrexate Injection, Pre-filled Syringe 中国 Severe recalcitrant disabling psoriasis and other autoimmune diseases
Adult rheumatoid arthritis
Methylthioninium Chloride Enteric-coated Sustained-release Tablets China An diagnostic agent to enhance visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy
Desidustat Tablets* China Anemia in patients with chronic kidney disease
Cyclosporine Eye Drops 0.09% China Increasing tear secretion in patients with keratoconjunctivitis sicca (dry eye)
Latanoprost Eye Drops China Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
PLENITY China
EU
An aid for weight management in adults with a BMI of 25-40 kg/m2 when used in conjunction with diet and exercise
Levetiracetam XR Tablet China Adjunctive therapy for the treatment of partial-onset seizures
BCG for Intravesical Instillation#
(Biological Agent)
China Non-invasive urothelial bladder carcinoma, including curative treatment of carcinoma in situ and prophylactic treatment of recurrence
PoNS China Chronic balance deficit due to mild-to-moderate traumatic brain injury

* In March 2022, New Drug Application of Desidustat Tablets was approval for marketing in India
# Taiwan is not included in the rights authorized region of BCG for Intravesical Instillation

Under R&D Stages

Global
Global
Designated Asian Regions
Designated Asian Regions
Mainland China, HK SAR, Macao SAR and Taiwan
Mainland China, Hong Kong, Macao and Taiwan
China
China
Overseas
Overseas

Product Rights Authorized Region Indication Pre-clinical Clinical Trial Approval Phase I Phase II Phase III Marketing Application
SDN – 037 China Eye pain and inflammation after cataract surgery
PDP – 716 China Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
CF101 China Psoriasis
ACT017
(Biological Agent)
China
Designated Asian Regions
Acute phase of ischemic stroke
CF102 China Hepatocellular carcinoma
Non-alcoholic fatty liver disease / non-alcoholic steatohepatitis
XF – 73 China
Designated Asian Regions
Prevention of post-surgical staphylococcal infections
Infectious diseases
BB2603 China
EU
Onychomycosis and tinea pedis
VXM01
(Biological Agent)
China
EU
Recurrent glioblastoma
VEGF/ANG2 Tetravalent Bispecific Antibody
(Biological Agent)
Global Intended to be used for ocular fundus neovascular diseases
Fully Human Anti-SA Hlα Antibody
(Biological Agent)
China Intended to be used to prevent disease progression in high-risk groups for SA colonization and treat pneumonia, bacteremia, and toxic shock caused by SA, especially MRSA
Fully Human Anti-HCMV Antibody
(Biological Agent)
China Intended to be used for prophylaxis of HCMV infection
Fully Human Anti-COVID-19 Antibody
(Biological Agent)
全球 Intended to be used for prevention and treatment of COVID-19 infection
Fully Human Anti-rabies Virus Antibody
(Biological Agent)
全球 Intended to be used for rapid passive immunization of patients bitten and scratched by rabies infected dogs or other animals susceptible to rabies infection
CMS — D001 Global Autoimmune diseases
CMS — D002 Global Gynecological diseases
CMS — D003 Global Cardio-cerebrovascular diseases
CMS — D004 Global Central nervous system diseases
CMS — D005 Global Metabolic diseases