Pipeline

April 29, 2019

Company	Drug/Device	Medical Condition	Status
Innovent Biologics, Inc. and Eli Lilly & Company	IBI318	advanced malignancies	Phase I trial initiated enrolling subjects in China
TC BioPharm	TCB002	Acute Myeloid Leukemia (AML)	Phase I trial initiated enrolling 9 subjects in Prague, Czech Republic
Innovent Biologics, Inc.	IBI302	wet age-related macular degeneration (wet AMD)	Phase I trial initiated enrolling 36 subjects
Vaxiion Therapeutics, Inc.	VAX014	non-muscle invasive bladder cancer (NMIBC)	Phase I trial initiated
Indalo Therapeutics	IDL-2965	nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF)	Phase I trial initiated
Galapagos NV, MorphoSys AG and Novartis Pharma AG	MOR106 in combination with topical corticosteroids	moderate to severe atopic dermatitis	Phase II trial initiated enrolling 60 subjects
Forbius	AVID100	EGFR-overexpressing Triple Negative Breast Cancer (TNBC)	Phase IIa trial initiated enrolling 100 subjects
Evofem Biosciences, Inc.	Amphora	sexually transmitted bacterial infections	Phase IIb trial initiated enrolling more than 850 female subjects who had been treated for chlamydia or gonorrhea in the preceding four months
TaiGen Biotechnology Company, Limited	Furaprevir in combination with Yimitasvir	chronic hepatitis C	Phase III trial initiated enrolling 360 subjects with both cirrhotic and non-cirrhotic genotype 1 in China
GlycoMimetics, Inc.	uproleselan	Acute Myeloid Leukemia (AML)	Phase III trial initiated enrolling 250 subjects with relapsed/refractory AML
Mallinckrodt, plc	Acthar Gel (Repository Corticotropin Injection)	Systemic Lupus Erythematosus (lupus, SLE)	Phase IV trial initiated enrolling 172 subjects with persistently active SLE
Beckman Coulter	Early Sepsis Indicator	sepsis	510(k) clearance granted by the FDA
TELA Bio, Inc.	Restella Reconstructive BioScaffolds	reconstructive surgery	510(k) clearance granted by the FDA
Repro-Med Systems, Inc.	HIgh-Flo Super26 Subcutaneous Needle Sets	subcutaneous infusion of medications	510(k) clearance granted by the FDA
Akorn, Inc.	Fluticasone Propionate Nasal Spray	temporary relief of hay fever and other upper respiratory allergies in adult and pediatric subjects 4 years of age and older	ANDA approval granted by the FDA
Akorn, Inc.	Loteprednol Etabonate Ophthalmic Suspension, 0.5%	post-operative inflammation following ocular surgery	ANDA approval granted by the FDA
Moleculin Biotech, Inc.	Annamycin	relapsed or refractory acute myeloid leukemia (AML)	Fast Track designation granted by the FDA
GENFIT	elafibranor	Primary Biliary Cholangitis (PBC) in adult subjects with inadequate response to ursodeoxycholic acid (UDCA)	Breakthrough Therapy designation granted by the FDA
Viela Bio	inebilizumab	neuromyelitis optica spectrum disorder (NMOSD	Breakthrough Therapy designation granted by the FDA
Knopp Biosciences, LLC	dexpramipexole	hypereosinophilic syndrome (HES)	Orphan Drug designation granted by the FDA
NeuroSigma, Inc.	Monarch eTNS System (Monarch)	attention deficit hyperactivity disorder (ADHD)	Clearance to market granted by the FDA
BAROnova, Inc.	TransPyloric Shuttle (TPS) Device	obesity	Approval granted by the FDA
Boston Scientific Corporation	LOTUS Edge Aortic Valve System	severe aortic stenosis	Approval granted by the FDA
AbbVie	SKYRIZI (risankizumab-rzaa)	moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy	Approval granted by the FDA
Merck	KEYTRUDA in combination with Inlyta (axitinib)	advanced renal cell carcinoma (RCC)	Approval granted by the FDA
Teva Pharmaceutical Industries Ltd.	generic naloxone hydrochloride nasal spray	opioid overdose	Approval granted by the FDA