Pipeline

December 10, 2018

Company	Drug/Device	Medical Condition	Status
Innovent Biologics, Inc.	IBI101, a recombinant fully human anti-OX40 monoclonal antibody (mAb) drug candidate	Advanced solid tumors	FDA approved Investigational New Drug (IND) application and plans to initiate Phase I clinical trial based on results from China Phase I trial
Sunny Pharmtech, Inc. and Vitruvius Therapeutics, Inc.	Aminocaproic Acid Tablets 500 mg and 1000 mg tablets	Fibrinolysis	FDA approved Abbreviated New Drug Application (ANDA)
Vybion, Inc.	INT41	Huntington’s disease	FDA granted Orphan Drug designation
Ocular Therapeutix™, Inc.	RP-L201	DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg	Occular pain following eye surgery
Notal Vision, Ltd.	Notal Vision Home-based Optical Coherence Tomography (OCT) System	Home testing between doctor ntra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD)	FDA granted Breakthrough Device designation
Mirati Therapeutics, Inc.	MRTX849	Cancers driven by KRAS G12C mutations	FDA has cleared the company's Investigational New Drug (IND) application to initiate Phase I/II Trial
AbbVie	Rovalpituzumab Tesirine (Rova-T)	Second-line therapy for advanced small-cell lung cancer	Halted Phase III trial due to shorter overall survival in the Rova-T arm
Genentech, Inc.	Kadcyla® (ado-trastuzumab emtansine)	HER2-positive early Breast cancer (EBC)	Phase III KATHERINE trial met its primary end-point, significantly reducing risk of recurrence or death compared to Herceptin® (trastuzumab) as an adjuvant treatment
Global Blood Therapeutics	Voxelotor	Sickle cell disease in patients 12 and older	Interim analysis of its Phase III HOPE study showed patients experienced “rapid, robust and sustained improvements in hemoglobin levels and measures of hemolysis with a favorable safety and tolerability profile”
Seattle Genetics	Adcetris	Previously untreated systemic anaplastic large cell lymphoma	Granted approved by FDA
Novartis	ligelizumab (QGE031)	Chronic spontaneous urticartia (CSU) whose symptoms are inadequately controlled by H1-antihistamines	Taking it into Phase III trials after a mid-stage trial showed out-performed Xolair
Janssen Pharmaceutical	IMBRUVICA® (ibrutinib) plus rituximab	Chronic lymphocytic leukemia (CLL); small lymphocytic lymphoma (SLL)	Phase III trial results: significantly prolonged PFS compared to FCR in previously untreated patients aged 70 years or younger with CLL/SLL
Exelixis, Inc. and IPSEN	Cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) previously untreated advanced HCC	Previously untreated advanced hepatocellular carcinoma (HCC)	initiation of COSMIC-312, a Phase III pivotal trial of this med versus sorafenib