Xinda Biology
In November 2021, Cinda Biology announced the results of the phase Ib clinical study on the multiple administration of anti recombinant human anti vascular endothelial growth factor (VEGF)/anti complement fusion protein injection IBI302 in patients with neovascular age-related macular degeneration (nAMD). IBI302 is the world's first anti VEGF anti complement dual target drug. In the clinical research of fundus diseases, IBI302 has shown good safety and tolerance, and has achieved vision improvement effect. IBI302 is an innovative drug independently developed by Xinda Bio for the treatment of fundus diseases. As a Class 1 new drug, IBI302 has been supported by the major new drug creation project of the Ministry of Science and Technology of the People's Republic of China.
Structural diagram of IBI302 [1]
Age related macular degeneration (AMD) is a chronic progressive disease that involves the macular region of the retina and leads to central visual impairment. It is an important disease that causes blindness in the elderly at present, and the incidence increases with age. Symptoms of AMD include central vision loss, distortion and scotoma. AMD comes in two forms: dry and wet. Dry AMD accounts for nearly 85-90% of all cases. It occurs in the early stage of AMD and is caused by vitreous warts in the central macula of the retina. It usually does not seriously affect vision. Approximately 10-15% of dry AMD patients will develop wet AMD. Wet AMD occurs in the late stage of AMD, which is caused by abnormal blood vessels proliferating in the choroid at the back of the retina. These new blood vessels can cause bleeding or fluid leakage, leading to subretinal hemorrhage or retinal tissue swelling. The potential consequences are irreversible scar tissue and loss of vision. Although wet AMD only accounts for 10-15% of all AMD cases, it is the main cause of irreversible loss of central vision in AMD patients over 65 years old. The incidence of AMD in China is increasing year by year, and it has become the third leading cause of blindness in China. Risk factors include smoking, obesity, family history and race. In addition, inflammation mediated by abnormal complement activation is also considered to be an important cause of AMD.
At present, anti VEGF therapy is the standard treatment of nAMD. IBI302 is an anti VEGF and anti complement double target specific recombinant whole human fusion protein independently developed by Xinda Biopharmaceutical. The N-terminal can block VEGF mediated signal pathway, inhibit the survival and proliferation of vascular endothelial cells, thereby inhibiting angiogenesis, reducing vascular permeability and reducing vascular leakage; The C-terminal of IBI302 can specifically bind C3b and C4b, inhibit the activation of the classical complement pathway and bypass pathway, reduce the complement mediated inflammatory response, so as to achieve the treatment of AMD and inhibit the formation and progress of macular atrophy and fibrosis.
Ophthalmology
xerophthalmia
Cyclosporine A ophthalmic gel
The eye gel based on cyclosporine A is an innovative hydrogel preparation, which can spread faster and stay longer on the eye surface. At present, Phase III clinical trial is being conducted in China to evaluate the efficacy and safety of cyclosporine A ophthalmic gel in patients with moderate to severe dry eye.
RGN-259
Eye drops for the treatment of moderate to severe dry eye disease are therapeutic peptides (thymosin β 4) It has the characteristics of protecting cells and tissues and promoting repair and regeneration. RGN-259 has a new mechanism with dual effects of corneal repair and anti inflammation. Research shows that it has a rapid effect on a variety of signs and symptoms.
Cyclosporine A/Ribapet
The innovative combination ophthalmic gel with dual mechanisms of anti inflammation and tear film stabilization has better efficacy for patients with insufficient response to cyclosporine A. In the preclinical study, cyclosporine A/rebamipide ophthalmic gel has obvious effect on improving the signs and symptoms of dry eye in rabbits.
IC-265
An eye drop composed of highly selective and powerful Syk tyrosine kinase inhibitor, which has extensive anti-inflammatory effects and also shows extensive efficacy in reducing signs of allergic conjunctivitis.
wet age-related macular degeneration 
TAB014 (bevacizumab)
Clinically proven anti VEGF drugs. The WHO list of essential drugs also lists bevacizumab for the treatment of eye diseases. TAB014 was registered with the State Food and Drug Administration as a Class 1 new drug route for the indication of wet age-related macular degeneration in China.
PAN-90806
VEGFR2 inhibitor. It is an anti VEGF preparation using a new type of eye drops for the treatment of wet age-related macular degeneration and diabetic macular edema. PAN-90806 is a small molecule compound with the best physical and chemical properties, which can be used for external drug delivery.
Diabetic macular edema
ZK002)
It has a new mechanism of action to inhibit inflammation (i.e., anti-inflammatory effect) and vascular leakage (i.e., anti permeability effect), and its efficacy may be better than the existing main methods to treat diabetic macular edema. It also has anti angiogenesis and anti-inflammatory effects, and can be used as an ideal candidate drug for the treatment of pterygium.
myopia
ZKY001
Thymosin β 4. The corneal epithelial defect was treated by anti inflammation and stimulating epithelial cell migration. Compared with the widely used growth factor therapy that stimulates angiogenesis and may cause edema and inflammation, ZKY001 has better in vivo efficacy in reducing corneal edema and inhibiting abnormal angiogenesis in the eyes in preclinical animal models. It has good safety and tolerance.
Allergic conjunctivitis
IC-270
It is a fixed dose compound of IC-265 and antihistamines for the treatment of allergic conjunctivitis. Syk tyrosine kinase inhibitor of IC-265 can reduce redness and inflammation, while antihistamines can control itching. By combining these two ingredients, IC-270 has the potential to become a therapy for allergic conjunctivitis, which can not only treat itching, but also solve redness and inflammation related to allergic conjunctivitis.
Anti infection/anti-inflammatory, diagnostic and surgical use
NTC010
It is an eye drop used to prevent and treat inflammation and infection related to cataract surgery. NTC010 is a fixed combination of 0.5% levofloxacin (a broad-spectrum quinolone antibiotic) and 0.1% dexamethasone (a corticosteroid anti-inflammatory drug).
NTC014
The eye drops for the treatment of moderate to severe bacterial conjunctivitis indications are an innovative fixed dose combination of 0.5% levofloxacin and 0.5% ketorolac tromethamine.
Vitreomacular adhesions
Resolv ER
It is an intravitreal injection of liposome urea for the treatment of vitreomacular adhesion (VMT). Resolve ER is a urea solution encapsulated in liposomes. Liposomes are biodegradable and biocompatible carriers that can provide sustained release for a long time. By using Resolve ER, patients with vitreomacular adhesions can avoid invasive surgery and maintain vision.
Canonical organism
In order to meet the unmet needs in the treatment and management of ophthalmic diseases, Classic Bio is committed to developing the first or best ophthalmic treatment method of the same kind. In addition to the Biosynthetic Cornea Project (EB-301), a series of next-generation biotherapies for retinal diseases (EB-101, EB-102, EB-105 and EB-107) are currently being developed. EB-101 is the second generation of multivalent intravitreal injection drug, which is independently developed by Classic Biology and is used to treat nAMD and other retinal vascular diseases.
EB-101, EB-102 and EB-105 are in the pre clinical stage for wet AMD, diabetic macular edema (DME) and diabetic retinopathy (DR). EB-108 is a pre clinical asset of the first biological agent being developed for dry AMD. EB-109 is a new oral therapy in clinical stage, which is used to treat the blindness of rare children with Leber congenital amaurosis (LCA) or retinitis pigmentosa (RP) caused by RPE65 or LRAT gene mutation. EB-301 is a new type of clinical synthetic cornea originated from recombinant human collagen. EB-301 is designed to treat vision defects associated with corneal blindness because stable, noninfectious stromal lesions are suitable for anterior lamellar keratoplasty (ALK) as an alternative to donor corneas.
Dianjing Biological Ophthalmic Drug Pipeline (from the official website)
Newforth Biology
Newforce Biology focuses on in vivo gene therapy of ophthalmic diseases and is committed to developing new therapies for patients with ophthalmic diseases worldwide. As the first ophthalmic gene therapy company in China, with the help of the mature AAV gene therapy technology platform, Newfoss has established a wealth of product pipelines, including more than 10 ongoing research projects for various ophthalmic diseases such as optic nerve injury diseases and vascular retinopathy. It is committed to the R&D and industrialization of gene therapy drugs with adeno-associated virus as the carrier to explore and develop new therapies for patients with ophthalmic diseases worldwide. NR082 is the first ophthalmic in vivo gene therapy drug approved for clinical trials in China, and also the first Chinese ophthalmic in vivo gene therapy drug approved for clinical trials by the US FDA.
Newforce biological product pipeline (from the official website)