【Today's hot spots】Many leading enterprises in the industry announced important plans for 2022, and 2021 ended successfully!

1. CStone Pharmaceuticals announced that the registered clinical study (GEMSTONE-201) of Suglizumab injection (trade name: Zejiemei) for the treatment of relapsed or refractory extranodal natural killer cell/T cell lymphoma (R/R ENKTL) reached the main research endpoint. In December 2021, NMPA approved the marketing of shuglimab for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer in combination with pemetrexed and carboplatin for patients with metastatic non-squamous non-small cell lung cancer with mutant mutations in epidermal growth factor receptor (EGFR) genes, and in combination with paclitaxel and carboplatin for patients with metastatic squamous non-small cell lung cancer. In addition, shugliltumab has undergone several registered clinical trials, including a Phase 2 registered clinical trial for lymphoma and four Phase 3 registered clinical trials for phase III, IV. non-small cell lung, gastric and esophageal cancers, respectively.

2. The Philippines has approved the recombinant two-component new crown pneumonia vaccine (CHO cells) developed by Ruike Biotech to carry out Phase II/III clinical research. The study was a global multicenter, randomized, double-blind, placebo-controlled study to further evaluate the efficacy, safety and immunogenicity of the ReCOV vaccine in adult subjects aged 18 years and older. At present, Reco Bio has submitted applications for Phase II/III clinical trials of ReCOV vaccines to many countries around the world, and the Philippines is the first country to approve Phase II/III clinical studies of ReCOV vaccines.

3. Sibiman Biotech announced that the US FDA granted C-CAR039 Advanced Regenerative Medicine Accreditation (RMAT) and fast-track qualification for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). C-CAR039 is a novel autologous bispecific CAR-T cell therapy that targets both CD19 and CD20 antigens, which can effectively remove CD19/CD20 single-positive or double-positive tumor cells in vivo and in vitro. Previously, a clinical trial initiated by researchers conducted in China demonstrated that C-CAR039 showed good safety and encouraging clinical efficacy in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-cell NHL), in addition, the company launched a Phase 1b/2 clinical trial of the therapy in the United States.

4. The latest news from the Pony test official micro, the rapid detection service of Pliny medical human helicobacter pylori is online. Pony Medical is medically relevant to the testing and can perform a rapid testing service for Human Helicobacter pylori through the Carbon 13 Breath Test. The carbon-13 breath test is non-traumatic, painless, and non-radioactive, providing customers with accurate Helicobacter pylori test results safely and quickly.

5. Microchip Bio released, and the phase II clinical trial of cydabenamine combined with tirelizumab in the first-line treatment of PD-L1 expression positive for local advanced or metastatic non-small cell lung cancer was approved. Chidamide (trade name "Epidaza") is a national class 1 original innovative drug, which is the world's first subtype selective histone deacetylase (HDAC) inhibitor, which can solve diseases such as malignant tumors that seriously threaten human health alone or in combination with other drugs. Tirelizumab (BGB-A317), a drug candidate developed by BeiGene's Immuno-Tumor Bio-Platform, is an investigated human-derived monoclonal antibody that belongs to a class of tumor immune drugs called immune checkpoint inhibitors that bind to the cell surface receptor PD-1.

6. According to the public information of the Drug Evaluation Center (CDE) of the State Drug Administration of China (NMPA), BeiGene BTK targeted protein degrader BGB-16673 has been approved for clinical trials in China, which is the second BTK-PROTAC approved in China and the third approved clinical in the world. BGB-16673 is BeiGene's first project developed based on its Chimeric Degradation Activating Compound (CDAC) technology platform. The preclinical model shows that the targeted degradation of BTK by BGB-16673 can overcome C481S resistance, which is expected to break through the problem of BTK inhibitor resistance. At the same time, BGB-16673 has good pharmacological properties, bioavailability, tolerability, as well as high selectivity, effectiveness and long half-life.

7. Kelun Pharmaceutical announced that the 1 class new drug KL340399 injection was approved for clinical trials, which is a new generation of small molecule STING agonists, and no drugs with the same target have been approved for marketing. STING, a transmembrane protein, is an important linker protein in the innate immune signaling pathway, which has the function of recognizing viral and bacterial infections and initiating the body's inherent defenses and immune responses. Activating the STING pathway can induce the expression and secretion of type I interferons and other pro-inflammatory factors, activate the inherent immune response, promote the anti-tumor immune response, and achieve the purpose of treating tumors.

8. Kangfeng Biologics, which focuses on minimally invasive treatment technology of cryoablation, submitted a prospectus on the Hong Kong Stock Exchange and prepared to be listed on the main board of Hong Kong. With its unique liquid nitrogen cryoablation technology, it focuses on two main therapeutic areas: (i) vascular interventional therapy for cardiovascular diseases such as atrial fibrillation and hypertension, and (ii) natural endoscopic surgery (NOTES) for urinary, respiratory and digestive diseases (e.g. bladder cancer, COPD, asthma, airway stenosis, gastric cancer and esophageal cancer). Confeng Bio's core products, the bladder cryoablation system and the endoscopic anastomosis clip, have demonstrated outstanding trial results in their respective clinical trials, and the company has launched six minimally invasive surgical consumables products, and the commercialization work has begun to bear fruit.

9. Ruizheng Gene (Suzhou) Co., Ltd. and N1 Life jointly announced a strategic cooperation, according to the agreement, the two sides will set up a joint venture in China - Lianan Jurui Life Science and Technology (Suzhou) Co., Ltd., focusing on the development of a new generation of drug delivery system to quickly promote the clinical transformation of drug candidates. Based on their respective technical advantages and strong resources, the two sides will cooperate to further develop drug delivery technology to achieve clinical transformation of products and ultimately benefit patients.

10. Beijing Darwin Cell Biotechnology Co., Ltd. announced the completion of the A+ round of financing of 130 million yuan. The financing was led by the Sub-Fund of the National Small and Medium-sized Enterprise Development Fund managed by Qingkong Ginkgo, and followed by Jinan Blue Sky Investment Co., Ltd. As a national high-tech enterprise, Beijing Darwin Cell Biotechnology Co., Ltd. has completed the breakthrough verification of clinical transformation in the second half of 2021 after 10 years of deep cultivation in the clinical transformation and application of stem cells, and has obtained a number of core patents at home and abroad. It has outstanding performance in three areas: hair follicle repair, joint repair, and nerve repair.

11. Biotechnology company Adagio Therapeutics has published three independent publications showing that its leading monoclonal antibody (mAb) ADG20 has neutralizing activity against the Omilon of SARS-CoV-2 and outlines initiatives to address current and future concerns about the SARS-CoV-2 variant. The company is evaluating phase 2/3 of ADG20's phase 2 clinical trials to prevent and treat the coronavirus worldwide. Adagio said it is communicating with the U.S. FDA about a potential regimen for its phase 2/3 global clinical trials, including increasing the dose of ADG20. The results of all three studies show that ADG20 is one of the few monoclonal antibodies with neutralizing activity against Omikeron in the later stages of clinical development or in the form of an Emergency Use Authorization (EUA).

12. Eli Lilly said at JPM 2022 that this year will usher in the approved GIP/GLP-1 dual agonist tirzepatide or take the dual brand route, which is adapted to type 2 diabetes and obesity respectively. The drug's first major obesity clinical trial, CONVERSE-1, is scheduled to release data in April, while a new class of drugs to treat type 2 diabetes is currently under review in the United States and the European Union. Previously, Novo Nordisk has divided the drug semaglutide for injection GLP-1 into 2 independent brands: Ozempic, a drug for diabetes, and Wegovy, a drug for obesity.

13 Moderna said at JPM 2022 that it has raised its covid-19 vaccine sales forecast to $18.5 billion from $17 billion in 2022. The company recently signed contracts with the United Kingdom, Switzerland and South Korea to provide COVID-19 vaccines this fall. Moderna CEO Stéphane Bancel also introduced the company's 2022 product strategy. The mRNA expert hopes to bring to market an annual pan-respiratory enhancement vaccine that protects against COVID, influenza and respiratory syncytial virus infections.

14. ABL Bio Corporation of South Korea announced a global exclusive cooperation and licensing agreement with Sanofi to jointly develop and commercialize ABL301. The ABL301 is a potential "first-in-class" bispecific antibody in the preclinical phase that targets α-synuclein and IGF1R to enhance the blood-brain barrier (BBB) penetration of the antibody for the treatment of Parkinson's disease and other potential indications. Preclinical studies have demonstrated that compared with monoclonal antibodies, Grabody-B can significantly improve the blood-brain barrier permeability of various therapeutic antibodies in rodents and non-human primates, with better efficacy or pharmacodynamic effect, and because of its superior blood-brain barrier penetration ability, ABL301 in Parkinson's disease mouse model, compared with α-synuclein monoclonal antibodies, showed better efficacy in reducing brain α-synuclein deposition.

15. AstraZeneca said that new preliminary data show that the Vaxzevria covid-19 vaccine has enhanced the antibody response to several new coronavirus variants after injecting a third dose. Trials have shown that Vaxzevria has enhanced immune response to COVID-19 beta, delta, alpha and gamma variants and is generally well tolerated. Another analysis of the test samples showed that antibody responses to the Omiljunn variant were also enhanced, the company said.