National Health Commission Releases 2024 Obesity Management Guidelines Featuring GLP-1 Therapies; Key Players Including Hengrui, Huadong, Merck, and AstraZeneca Advance Pipeline Assets

丨China's National Health Commission Issues "2024 Edition of Obesity Diagnosis and Treatment Guidelines"

10Month17On [Date], the National Health Commission issued "2024The 2023 Edition of the Obesity Diagnosis and Treatment Guidelines," which is the first authoritative guide for multidisciplinary obesity treatment in China, is significant for standardizing clinical diagnosis and treatment of obesity in the country and improving the homogeneity of obesity treatment across medical institutions.

The guidelines classify obesity into four categories. For a long time, the definition of obesity in China has been:BMIAchieve24 kg/m² and lower than28 kg/m² indicates overweight, reaching or exceeding28 kg/m² is obesity. However, this classification method is no longer suitable for the current obesity status of the population. Therefore, the new guidelines further subdivide obesity into four levels: mild, moderate, severe, and extremely severe, to facilitate clinical treatment according to specific conditions.

The new edition of the guidelines includes a section on pharmacotherapy: When individuals are overweight and have at least one weight-related comorbidity, such as abnormal blood glucose, lipids, or blood pressure, non-alcoholic fatty liver disease, obstructive sleep apnea syndrome, cancer, and other conditions, weight-loss medications may be used in combination for treatment.

Guidelines recommend5Weight loss drugs. In addition to the traditional Orlistat, there are Liraglutide, Benaglutide, Semaglutide, and Tirzepatide.4All products areGLP-1Class of drugs. (Jian Shi Ju)

丨Dizal's New Lung Cancer Drug Sunvozertinib Receives Fourth Breakthrough Therapy Designation

10Month13Dizal Pharmaceutical announced that the Center for Drug Evaluation of the National Medical Products Administration of China (CDE) to include its novel targeted lung cancer drug, Sunvozertinib (generic name: Sunvozertinib Tablets), as a breakthrough therapy for patients who have not received systemic treatment and carry the epidermal growth factor receptor (EGFR）20Exon Insertion Mutation (exon20ins) locally advanced or metastatic non-small cell lung cancer (NSCLC). With this latest designation as a breakthrough therapy, the product has now received4This breakthrough therapy designation. Public information shows that earlier, Sunvozertinib tablets second-line/Later-line TreatmentEGFR exon20ins NSCLCThe indications in China areNMPAIncluded in the breakthrough therapy category and in the United States beingFDAGranted Breakthrough Therapy Designation. (Dizal)

丨Apeiron's New Cancer Drug Approved for Clinical Trials

On October 14, Apeiron Therapeutics announced that the IND application for its second-generation MTA-cooperative PRMT5 inhibitor, GTA182, has been approved by the National Medical Products Administration of China. It is intended for development to treat MTAP-deficient solid tumors.Protein Arginine Methyltransferase 5 (PRMT5) inhibitors are an emerging class of anti-tumor drugs and are also considered one of the next promising "synthetic lethality" therapies following PARP inhibitors. They can form a "synthetic lethality" partnership with MTAP gene mutations.MTAP (methylthioadenosine phosphorylase) is co-deleted with the tumor suppressor gene CDKN2A in 10% to 15% of various types of cancer patients.(Apeiron)

丨RemeGen's ADC Drug Disitamab Vedotin Submits for Market Approval for Breast Cancer Indication

On October 15, the latest announcement on the CDE website showed that the marketing application for a new indication of Rongchang Bio's HER2-targeted antibody-drug conjugate (ADC) Disitamab Vedotin for Injection has been accepted.According to the CDE official website, the marketing application has been included in the priority review this September. It is applicable for HER2-positive (HER2 immunohistochemistry test result of 3+ or FISH+) advanced breast cancer patients with liver metastases who have previously received trastuzumab or its biosimilars and taxane drug treatments.Disitamab vedotin (RC48) is an ADC targeting HER2 developed by Rongchang Bio, and it has already been approved for two major indications in China: gastric cancer and urothelial carcinoma.(RemeGen)

丨Hengrui PD-1 Once Again Files for U.S. Market Listing

On October 15, Hengrui Medicine announced that the resubmitted Camrelizumab license application has been accepted by the FDA. The declared indication is Camrelizumab in combination with Apatinib for the first-line treatment of unresectable or metastatic liver cancer.Hengrui disclosed in the announcement that the combination of Camrelizumab and Apatinib provides the longest OS benefit for first-line treatment of advanced liver cancer.The latest results show that, compared to standard treatment, the median overall survival was significantly extended to 23.8 months with this combination regimen.This application marks the second attempt by Hengrui's "Double AI" combination to enter the U.S. market.In May this year, Hengrui Medicine announced:The FDA rejected the marketing application for this PD-1 combination regimen, citing production-related issues as the reason.(Hengrui Medicine)

丨HaiChuang Pharma's Oral Protein Degrader Approved for Clinical Trials

On October 15, Hua Cheng Pharmaceuticals announced that its Class 1 new drug HP568 tablets had received implied permission for clinical trials in China. The trials are planned to treat advanced breast cancer that is estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2- advanced breast cancer).HP568 is an orally available Proteolysis Targeting Chimera (PROTAC) drug independently developed by Hecan Pharma, designed to target and degrade ERα. It consists of three parts: a target protein ligand, an E3 ligase ligand, and a linker connecting the two ligands, and is intended for the treatment of ER+/HER2- advanced breast cancer.(HighTide Therapeutics)

丨Gensci Biotech's Class 1 New Cancer Drug Approved for Clinical Trials in the U.S.

On October 15, Changchun High-Tech announced that its subsidiary, GenSci, had received the FDA's IND approval for the GenSci122 tablet project.GenSci122 is a small-molecule KIF18A inhibitor with a novel structure independently developed by Jin Sai Pharmaceuticals, and it is also a new anti-tumor drug based on the "synthetic lethality" mechanism.In China, the clinical study application for GenSci122, filed under Registration Category 1, was accepted by the CDE at the end of September this year.KIF18A is a "synthetic lethal" target.KIF18A Inhibitors Induce Synthetic Lethality with Chromosomal Instability (CIN) and Whole Genome Doubling (WGD)+.According to the announcement by Changchun High-Tech, GenSci122 is an effective and selective KIF18A inhibitor, exhibiting antitumor characteristics that are significantly distinct from other cell cycle and anti-mitotic drug targets.(Gensci Biotech)

丨Hepalink Subcutaneous Injection Antibody Class 1 New Drug Proposed for Inclusion in Breakthrough Therapy Category

On October 15, the latest announcement on the CDE website revealed that Hoicel Pharmaceuticals' application for the Class 1 new drug HMI-115 is proposed to be included in the breakthrough therapy designation, indicated for the treatment of moderate to severe pain associated with endometriosis.Public information shows that HMI-115 is a novel monoclonal antibody targeting the prolactin receptor (PRLR), and Hope Medicine has global rights to this product.HMI-115 is a novel monoclonal antibody drug targeting PRLR.Studies show that the dysregulation of PRLR expression may be related to the pathogenesis of endometriosis, and drugs targeting prolactin and prolactin receptors may alleviate and control pain associated with this disease.In April 2019, Hope Medicine entered into a global exclusive licensing agreement with Bayer for the development and commercialization of HMI-115, a monoclonal antibody targeting PRLR. Hope Medicine is responsible for the global development and commercialization of this product across multiple indications.(Hope Medicine)

丨Huadong Medicine's Collaborative Development of ADC Cancer Drug Approved for Clinical Trials in China

On October 16, the latest announcement on the CDE official website revealed that HDP-101, a Class 1 new drug submitted by Heidelberg Pharma, has been approved for clinical trials. It is intended for the treatment of clonal hematological diseases positive for B-cell maturation antigen (BCMA), such as relapsed/refractory multiple myeloma.Public information shows that this is a BCMA-targeted antibody-drug conjugate (ADC) co-developed by Huadong Medicine.Public information shows that HDM2007 is an ADC targeting B-cell maturation antigen (BCMA).The product carries a synthetic mushroom toxin α-amanitin peptide derivative as its payload.Amanitin has a novel mechanism of action, inhibiting RNA polymerase II, effectively halting transcription and inducing apoptosis in tumor cells regardless of their proliferation status.(Huadong Medicine)

丨MicroCore Bio Cancer Class 1 New Drug Submits for Clinical Trial

On October 17, Chipscreen Biosciences announced that the CDE had accepted the clinical trial application for its Class 1 innovative drug CS231295 tablets for cancer treatment.According to the press release, CS231295 is a brain-penetrant small molecule multi-target protein kinase inhibitor independently developed by Chipscreen Biosciences. It can induce synthetic lethality in tumors carrying specific tumor suppressor gene defects.According to the press release from Chipscreen Biosciences, CS231295 can produce a synthetic lethal effect on tumors with specific tumor suppressor gene defects, offering targeted efficacy and providing a new treatment option for patients with such tumors.Meanwhile, CS231295 exhibits significant anti-tumor angiogenesis effects, achieving broad-spectrum anti-tumor activity.In the future, whether used as a single agent or in combination with other anti-tumor drugs, it is expected to provide differentiated and innovative treatment options for various types of tumors.(Chipscreen Biosciences)

丨Origincell's Dual-Target CAR-T Cell Therapy Approved for Clinical Trials

On October 17, the latest announcement on the CDE website revealed that OriCell Therapeutics' Class 1 new drug, OriC613 Injection, has been approved for clinical trials, intended for the development of treatment for advanced solid tumors.According to the press release from Origin Biosciences, this is their self-developed dual-target Claudin 18.2/MSLN autologous CAR-T cell therapy drug.The approval of OriC613's IND is another significant milestone for Apeiron Therapeutics in the development of new drugs.To address the On-Target/Off-Tumor toxicity issue in solid tumors, OriC613 employs an innovative dual-receptor logic-gating design strategy, which activates T cells only upon simultaneous recognition of two specific tumor antigens, and has already demonstrated strong data validation in preclinical studies.(Original Biotech)

丨Merck's New Pulmonary Hypertension Drug Submitted for Marketing Approval in China

On October 17, the official website of CDE announced that the marketing application for sotatercept injection submitted by Merck & Co. has been accepted.Public information shows that this is a "first-in-class" novel activin signaling inhibitor biologic, which has already been approved for marketing by the U.S. FDA in March this year for the treatment of pulmonary arterial hypertension (PAH).This therapy was previously rated by the industry media Evaluate as one of the potential blockbuster therapies of 2024.Sotatercept is a Type IIA activin receptor (ActRIIA) fusion protein.In preclinical studies, it can reverse the remodeling of the pulmonary artery wall and right ventricle.This product was also the key therapy that Merck acquired through the approximately $11.5 billion purchase of Acceleron Pharma in 2021.Previously, sotatercept had been granted Breakthrough Therapy Designation by the FDA for the treatment of pulmonary arterial hypertension.(MSD)

丨AstraZeneca's Cancer Immunotherapy Combination Submitted for Marketing Approval in China

On October 18, the latest announcement on the CDE website showed that the marketing applications of two new drugs from AstraZeneca were accepted, with specific indications yet to be disclosed.Durvalumab injection is a PD-L1 inhibitor, and tremelimumab is an anti-CTLA-4 monoclonal antibody.Based on the acceptance number, it can be inferred that the possible submission for marketing approval this time may be a combination therapy composed of these two drugs. This combination therapy was previously approved by regulatory agencies worldwide for first-line treatment of non-small cell lung cancer and first-line treatment of hepatocellular carcinoma.Durvalumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby interrupting tumor immune escape strategies and restoring suppressed immune responses.(AstraZeneca)

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