Duvelisib is for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after at least two prior systemic therapies.

SKLB1028 is a novel multi-target protein kinase inhibitor. Its major molecular targets include FLT3, EGFR, Abl, Fyn, Hck, Lck, Lyn, Ret and Yes. Pharmacology experiments at pre-clinical trial indicated exceptional inhibiting activity and good tolerance in various tumor treatments such as leukemia, non-small cell lung cancer, and in particular, acute myeloid leukemia (“AML”) with FLT3-ITD mutation.

SYHA121-28 is a Class 1 innovative drug developed by the Group as a new multi-target tyrosine kinase inhibitor that can inhibits EGFR, VEGFR and RET and its signal transmission within the cell. In the animal test, the drug showed positive therapeutic effect for esophageal, thyroid and gastric cancers. It is intended to be used for the treatment of gastrointestinal tumors, such as esophageal and gastric cancers

SYSA1801 is novel (first-in-class) anti-Claudin 18.2 monoclonal antibody-drug conjugate. Preclinical in vitro and in vivo animal studies have demonstrated that the Product can effectively target tumor cells through anti-Claudin 18.2 antibody and trigger endocytosis, bringing the small molecule toxin into tumor cells to achieve anti-tumor effects. The preclinical studies have shown that the Product has excellent in vivo and in vitro activity and good safety for pancreatic cancer, providing a promising prospect of demonstrating good efficacy in clinical trials.

SYHA1803 is a new type of small-molecule kinase inhibitor and currently there is no product of the same target available in the global market. The clinical indications approved for the Product include the treatment of intrahepatic cholangiocarcinoma and urothelial carcinoma. The pre-clinical studies indicated that the Product has an outstanding efficacy in respect of in vitro enzyme, cell activity and in vivo anti-tumor, and the characteristics of good safety and pharmacokinetics, providing a promising prospect of demonstrating good efficacy for the treatment of tumors in the clinical trials and bringing hope to those patients suffering from intrahepatic cholangiocarcinoma or urothelial carcinoma but without medication.

SYHA1807 is a new type of small-molecule kinase inhibitor and currently there is no product of the same type available in the global market. The clinical indication approved is for the treatment of small-cell lung cancer. The pre-clinical studies indicated that the Product has an outstanding efficacy in respect of in vitro and in vivo anti-tumor activity and good safety, providing a promising prospect of demonstrating good efficacy for the treatment of small-cell lung cancer in the clinical trials.

The Product is a multi-target inhibitor. The clinical indication for this approval is unresectable locally advanced or metastatic solid tumors, which include thyroid cancer, non-small cell lung cancer, gastric cancer (gastroesophageal junction cancer), colorectal cancer, pancreatic cancer and soft tissue sarcoma. The pre-clinical studies have shown that the Product has good efficacy on a number of tumors (including thyroid cancer, non-small cell lung cancer and gastric cancer) by inhibiting a variety of kinases with its high activity, and also has good safety as well as pharmacokinetic characteristics, providing a promising prospect of demonstrating good efficacy in the clinical trials.

The clinical indication approval is relapsed or advanced solid tumors, including high grade glioma, brain metastasis, kidney cancer, colorectal cancer, thyroid cancer, lung cancer, gastric cancer and giant cell tumor of tendon sheath. The pre-clinical studies have shown that the Product has good efficacy on a number of tumors (including glioma, kidney cancer, colorectal cancer) by inhibiting a variety of kinases with its high activity, and also has good safety as well as pharmacokinetic characteristics, providing a promising prospect of demonstrating good efficacy in the clinical trials.

The Product is a BTK inhibitor. The clinical indication for this approval is relapsed or refractory B-cell lymphoma, including but not limited to mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), waldenstrom’s macroglobulinemia (WM), marginal zone lymphoma (MZL), follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). The pre-clinical studies have shown that as a selective BTK inhibitor, the Product has a better efficacy in the treatment of B-cell malignancies and good safety as well as pharmacokinetic characteristics, providing a promising prospect of demonstrating good anti-tumor efficacy in the clinical trials.

As a highly selective cyclin-dependent protein kinase 9 (CDK9) inhibitor, SYHX1903 has great potential for the CDK9-targeted treatment of hematological malignancies and solid tumors. The indication for this clinical trial approval is hematological malignancies. Clinical trial application for advanced solid tumor indications will be filed at a later stage. The pre-clinical studies have shown that as a highly selective CDK9 inhibitor, the Product has significant efficacy in the treatment of hematological malignancies and solid tumors, good safety as well as pharmacokinetic characteristics, providing a promising prospect of demonstrating good anti-tumor efficacy in the clinical trials.

The Product is a Class 1 innovative chemical drug. As a highly selective PRMT5 inhibitor, the Product can be used alone or in combination with other drugs for the treatment of a variety of tumors. The indications approved are advanced malignant solid tumors and relapsed/refractory hematologic tumors. The pre-clinical studies have shown that the Product has significant efficacy in acute myeloid leukemia (AML), pancreatic cancer, melanoma and adenoid cystic carcinoma (ACC), as well as good safety and pharmacokinetic characteristics, providing a promising clinical development value.

NBL-015 is a fully human anti-Claudin 18.2 monoclonal antibody for treating advanced solid tumors with positive Claudin 18.2 expression, including pancreatic cancer and gastric cancer (including cancer of the gastroesophageal junction). NBL-015 has been previously granted orphan-drug designation for the treatment of pancreatic cancer and gastric cancer by the U.S. Food and Drug Administration (FDA), and its Investigational New Drug Application (IND) has also been approved by the U.S. FDA.

KN026 is a HER2-targeted bispecific antibody drug. Multiple phase I/II clinical trials of KN026 are being conducted in China and the U.S. to evaluate the potential for the treatment of breast cancer with medium/low or positive expression of HER2, advanced HER2-positive gastric cancer and gastroesophageal junction cancer, and other HER2-positive solid tumors.

The design of the Product adopts unique drug loading and release technology to ensure the nanoparticles can be effectively enriched in the tumor and the drug can be released reasonably after administration, thereby increasing the bioavailability of the drug in the tumor and leading to significant improvement in efficacy and safety. The rational design of the Product can also avoid skin toxicity and infusion-related reactions which are common in nanodrugs. Current clinical studies demonstrated that the Product has a significant improvement in efficacy in the treatment of ovarian cancer, head and neck squamous cell carcinoma, pancreatic cancer, breast cancer, small cell lung cancer, NKT cell lymphoma, soft tissue sarcoma and other tumors.

The Product is a class 2 chemical drug and the approved clinical indication is breast cancer. The pre-clinical studies indicated that the Product achieved anti-cancer effect through dual mechanism of inhibiting the mitosis of tumor cells and inhibiting the replication of angiogenic endothelial in tumor, and has outstanding in vivo efficacy with characteristics of good safety and pharmacokinetics, providing a promising prospect of demonstrating good efficacy for the treatment of breast cancer in the clinical studies.

The Product employs innovative human albumin encapsulation technology to deliver docetaxel in nanoparticles into patients. With this technology, docetaxel (albumin-bound) will eliminate the need for premedication that is required for all currently marketed docetaxel products, reduce the chance of infusion related hypersensitivity and improve patient compliance. In preclinical studies, docetaxel (albumin-bound) has demonstrated safety in several animal models and enhanced anti-tumor efficacy in several types of solid tumors.

The Product utilises special technology to encapsulate sirolimus into human serum albumin to overcome the shortcoming that oral formulation fails to deliver sufficient concentration of drug to target site, thus having the potential for treating a series of diseases caused by the mTOR signaling pathway. The Product has achieved administration of sirolimus by injection without hormone pretreatment and expanded the field of application of the drug. The clinical indication approved is for the treatment of solid tumors and hematological tumors. The preclinical study demonstrated that the Product has good anti-tumor activity in several models of solid tumors and hematological tumors, providing a promising prospect of demonstrating good anti-tumor efficacy in clinical trials.

SYHA1908 (the compound) is a new-generation taxane with high efficacy and low toxicity acting on the microtubule or tubulin system. Utilising human albumin as the carrier, the Product is independently developed by the Group to achieve effective delivery of the new-generation taxane in the body. The compound has no cytotoxicity towards normal tissue, but it can be converted into active substance by enzymes in the tumor microenvironment to activate anti-tumor effect, thus having a significantly improved safety window.

Cisplatin is a first-line drug for the treatment of several solid tumors, but its clinical application is limited by its severe adverse effects such as nephrotoxicity and neurotoxicity. The Group independently developed the Product using block copolymer as a carrier to achieve several unique advantages, including: (i) high drug loading capacity of cisplatin; (ii) lower toxic side effects by reduced accumulation of drugs in normal tissues; and (iii) preferential tumor accumulation attributable to the nanoscale size of cisplatin micelle, which is favourable for enhancing the therapeutic index.

The Product is a Class 1 innovative chemical drug developed by the Group with various patent applications submitted. The Product is a selective NTRK and ROS1 dual inhibitor. The indications for this clinical trial approval is solid tumor with NTRK or ROS1 gene rearrangement/fusion and positive resistance mutations. The pre-clinical studies have shown that the Product has excellent in vivo and in vitro activity and good safety, providing a promising clinical development value.

The clinical indication approved for the Product is diabetic neuropathy. The pre-clinical studies indicated that the Product can protect nerve cells by reversing pathological changes in the disease, and has outstanding in vivo efficacy with characteristics of good safety and pharmacokinetics, providing a promising prospect of demonstrating good efficacy for the treatment of diabetic neuropathy in the clinical studies.

SYHA1805 is a new type of small-molecule agonist and currently there is no product of the same type available in the global market. The clinical indication for this approval is treatment of nonalcoholic steatohepatitis (NASH). The pre-clinical studies have shown that the Product has a high selectivity of efficacy targets, can significantly ameliorate liver fibrosis and has excellent in vivo and in vitro activities as well as good safety, providing a promising prospect of demonstrating good efficacy in the clinical trials.

ALMB-0166 is a first-in-class humanized monoclonal antibody antagonist for novel target hemichannel connexin 43 membrane protein, which is independently developed by AlaMab Therapeutics Inc. (“AlaMab”), a subsidiary of the Company, for the treatment of acute spinal cord injury, stroke, osteoarthritis and other serious neurological diseases. ALMB-0166 has been granted orphan-drug designation by the U.S. FDA in 2018 for the treatment of acute spinal cord injury, and dosing in a Phase I clinical trial for the same indication in Australia has been completed with excellent safety and tolerability revealed.

As a dual-target inhibitor, SYHX1901 shows a relatively strong inhibitory activity with all subtypes of JAK and SyK kinases and has the potential to develop broad-spectrum treatment for autoimmune diseases. The clinical indications for this approval are rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). The pre-clinical studies have shown that the Product has a high selectivity of efficacy targets, can significantly ameliorate SLE skin lesions and lower the arthritis index score, and has excellent in vivo and in vitro activities as well as good safety, providing a promising prospect of demonstrating good efficacy on rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) in the clinical trials.

CM326 is a Class 1 innovative drug researched and developed by Chengdu Keymed with the new mechanism of action and global independent intellectual property rights targeting thymic stromal lymphopoietin (TSLP), and is the first drug developed for this target that is under clinical study in China.

NBL-012, a fully human antibody drug for treating chronic inflammatory diseases such as psoriasis, hidradenitis suppurativa (HS), inflammatory bowel disease (IBD) and other autoimmune diseases. As a fully human IgG4 antibody, NBL-012 should carry fewer risks of immunogenicity liability and undesirable Fc-mediated tissue damage. The development of NBL-012 will bring new and effective treatment options to patients with autoimmune diseases around the world.The Phase I clinical trials will evaluate the safety and tolerability and pharmacokinetic profile of NBL-012.

The Product is indicated for the treatment of patients with invasive fungal infections, patients where renal impairment or drug toxicity precludes the use of effective dose of amphotericin B or patients fail in prior amphotericin B deoxycholate treatment. Comparing with amphotericin B for injection used in clinical practice in China, the Product could significantly decrease nephrotoxicity and increase dosage, thus enhancing the therapeutic index. The approval of the Product will enable more patients to have chances to get treated or cured, hence having a better survival prognosis.

Clinically, alprostadil is mainly used for the treatment of chronic arterial stenosis and the associated cold extremities, pain and ulceration. Compared with the regular injection formulation available in the market, the alprostadil liposome injection developed by CSPC has distinct advantages in terms of its efficacy, stability and reduced side-effects.

Mingfule (rhTNK-tPA), a recombinant protein produced by using mammalian cells and genetic engineering technology, was independently developed by CSPC Recomgen and obtained marketing approval from NMPA in January 2015 for thrombolysis treatment in patients with acute myocardial infarction. Mingfule is a thirdgeneration rt-PA product, being a mutant of rt-PA: asparagine at locus 103 substitutes for threonine (“T”), glutamine at locus 117 substitutes for asparagine (“N”), and 4 alanines at loci 296-299 substitute for lysine, histidine and 2 arginines (“K”), respectively.

SYS6006 is a mRNA vaccine independently developed by the Group against SARS-CoV-2 virus mutant strains. Core mutations of prevalent variants have been specifically incorporated into antigen design during the development of the Product. Preclinical studies demonstrated the Product can generate high neutralizing activity against the prevalent variants (including Omicron and Delta strains), and is capable of providing protection through humoral and cellular immunity and inducing long-term memory B cells against SARSCoV-2 virus. Preclinical studies also showed good safety profile of the product.