The 7th China International Import Expo, which officially opened on November 5th, is probably one of the hottest topics in the past two days.Including giants such as Eli Lilly, Pfizer, AstraZeneca, Novo Nordisk, Sanofi, Johnson & Johnson, and Roche, more than 260 companies from around the world have brought their innovative pharmaceutical and medical products. Many of these are either global debuts or exclusive, rare disease drugs and products that have not yet been approved for marketing worldwide.For exampleGilead SciencesInnovative Drug Seladelpar for Primary Biliary Cholangitis (PBC), Sanofi'sInnovative Hemophilia Drug: Fitusiran Sodium Injection、Roche'sPI3Kα Inhibitor Inavolisib、Lunsumio (Mosunetuzumab), an innovative CD20/CD3 bispecific antibody for the treatment of B-cell lymphoma, as well as Johnson & Johnson'sRybrevant®, a bispecific antibody for the treatment of adult non-small cell lung cancerAndZebec® Compound for the Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Canceretc.Nowadays, the Chinese market has almost become a battleground for multinational pharmaceutical companies. However, the logic of the local market is changing with adjustments in policy regulation and industry competition. Therefore, accelerating the entry of innovative drugs into the Chinese market has become an important means for multinational pharmaceutical companies to seize their share of the market.At this year's CIIE, many multinational pharmaceutical companies have brought their "crown jewels." There are numerous first-time products, some of which are the first in China or even globally. Some have already been approved for marketing in China, while others are planned to gradually enter the Chinese market in the future.Gilead Sciences' treatment for primary biliary cholangitis, Seladelpar, is being exhibited in China for the first time.AlsoAn innovative drug for rare diseases that has not yet been approved worldwide, which received accelerated approval from the U.S. Food and Drug Administration in August 2024.Xinkangjie learned that theSeladelpar in March this yearGilead Sciences' $4.3 Billion Heavyweight Acquisition, its new drug application has been in AugustAccepted by the U.S. FDA and Granted Priority Review, for the treatment of primary biliary cholangitis (including pruritus) in adults with inadequate response or intolerance to ursodeoxycholic acid (UDCA), without cirrhosis or with compensated cirrhosis (Child-Pugh A). In addition, the relevant institutions of the UK MHRA and the European EMA have also accepted the drug's marketing review.In addition, Gilead SciencesLenacapavir for HIV Long-Acting Injectable TherapyThere are also new developments. The drug isThe world's first approved HIV capsid inhibitor drug, is also a long-acting HIV treatment regimen that requires dosing only twice a year. It has currently been approved in the EU and the United States for use in combination with other antiretroviral drugs to treat multidrug-resistant HIV-1 adult patients who have previously received multiple treatment regimens.In June this year, the interim results of a Phase III clinical trial of Lenacapavir disclosed by Gilead Sciences showed,The drug's effectiveness rate for pre-exposure prophylaxis (PrEP) in women reaches 100%., and is superior to Gilead Sciences' existing oral anti-HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate tablets). In September 2023, the marketing application for the 5.1 class new drug lenacapavir (lenacapavir) tablets submitted by Gilead Sciences to the Center for Drug Evaluation of China's National Medical Products Administration has been accepted.It is reported that,By the end of 2027, Gilead Sciences is expected to receive approval in China for four potential oncology indications, including three breast cancer indications and one non-small cell lung cancer indication.May this yearSanofi's innovative hemophilia drug, Fitusiran Sodium Injection, has been accepted for marketing application in China.This is also an innovative drug for a rare disease, and it is the world's first and only siRNA-based non-factor therapy for hemophilia. At this year’s CIIE, Sanofi showcased its global R&D pipeline, which includes this drug among 12 potential blockbuster products.Dupilumab Injection (Dupixent®)This is also the star product exhibited by Sanofi this time, boasting four "first and only" titles: the first and only biologic approved for moderate to severe atopic dermatitis across all age groups (6 months and above); the first and only biologic approved for adult moderate to severe prurigo nodularis; the first and only biologic suitable for type 2 asthma and OCS-dependent asthma patients that targets and inhibits both IL-4 and IL-13 pathways; and the first and only biologic for treating chronic obstructive pulmonary disease, revolutionizing the treatment of type 2 inflammatory diseases.In September this year, Dupilumab Injection (Dupixent®) was approved in China for adult patients with chronic obstructive pulmonary disease (COPD) who have elevated eosinophils and are not well controlled, and it was approved earlier than the U.S. FDA.Including Sanofi, Johnson & Johnson, Novo Nordisk, Roche, and AstraZeneca are all multinational pharmaceutical companies that have "fully attended" all seven editions of the CIIE.Johnson & JohnsonThis year, we have brought two "world premieres" and more than 20 "China premieres and first launches" of innovative pharmaceuticals and medical device products, includingRybrevant, the world's first approved EGFR/MET bispecific antibody for the treatment of non-small cell lung cancer.In addition, there are two innovative drugs for multiple myeloma, one isThe World’s First T-Cell Redirecting Bispecific Antibody Talvey, which can simultaneously bind to the CD3 receptor complex on T cells and GPRC5D on plasma cells; one isChina's First Launch of the World’s First and Only Ready-to-Use Bispecific Antibody Talikor。RocheThis time, it also brought more than 30 innovative products that have been launched and are about to be launched in China, includingThe world's first fully humanized anti-ST2 monoclonal antibody Astegolimab, and three of them are global innovative products that will be approved for the Chinese market.Specifically, these include: China's first and only PI3Kα inhibitor, Inavolisib; the first innovative CD20/CD3 bispecific antibody drug for the treatment of B-cell lymphoma to be launched globally, Lunsumio (Mosunetuzumab); and the world’s first and only drug approved for both relapsing multiple sclerosis and primary progressive multiple sclerosis, Ocrevus (Ocrelizumab).Showdown Between Two Major GLP-1 Blockbuster DrugsThe two major GLP-1 blockbuster drugs, Novo Nordisk's Semaglutide and Eli Lilly's Tirzepatide, also faced off at this year's CIIE.Novo Nordisk showcased 15 innovative drugs across multiple disease areas and 5 injection devices at this year's exhibition. Among them, 4 innovative drugs were recently approved for marketing in China this year, including the world’s first and currently only GLP-1 receptor agonist oral tablet, semaglutide (brand name: Rybelsus®), as well as the world’s first GLP-1 weekly formulation injection, semaglutide (brand name: Wegovy®), for long-term weight management.The latest data shows,Different formulations of semaglutide have contributed up to $20.3 billion in revenue to Novo Nordisk in the first three quarters of this year, marking a year-on-year increase of over 20%.As an important competitor of semaglutide, Eli Lilly also highlighted its GIP/GLP-1 receptor agonist tirzepatide injection (Mounjaro®) for type 2 diabetes and long-term weight management at this CIIE. Data shows,The total sales of Eli Lilly's tirzepatide-related products in the first three quarters of this year were approximately US$11.028 billion, and the estimated annual sales are expected to exceed US$16 billion.This year, these two drugs have also been successively approved for marketing in the Chinese market. In May, Eli Lilly's tirzepatide was officially approved in China for adults with type 2 diabetes, and then in July it was approved for long-term weight management indications. Additionally, Novo Nordisk's semaglutide injection (brand name: Wegovy®) had its marketing application approved by the Chinese regulatory authority in June.Xin Kangjie learned that, apart from Novo Nordisk and Eli Lilly,Boehringer IngelheimThe GCG/GLP-1 receptor dual agonist survodutide is also in phase III clinical trials, andThe company's relevant person in charge once revealed to the media that they hope the GLP-1 drug can enter the Chinese market within the next three to four years.AstraZeneca is also collaborating with the innovative Chinese pharmaceutical company Eternity Biopharma to co-develop an oral GLP-1 drug, ECC5004 (also known as AZD5004), for the treatment of obesity, type 2 diabetes, and other cardiometabolic diseases. Roche and Amgen also have related GLP-1 drug pipelines in development.It is worth mentioning that, in addition to semaglutide, Novo Nordisk also has another blockbuster drug——Icodec Insulin Injection (NovoCycle®)Also received approval from the Chinese regulatory authority in June for the treatment of adult Type 2 diabetes. This is alsoThe world's first and only approved once-weekly insulinIn 2020, Novo Nordisk launched the "China InnoCreation" program, incorporating China into its global synchronized R&D system. This drug is the first product to emerge from that initiative, achieving simultaneous clinical trials in China, the EU, and the U.S., as well as synchronized submission of marketing applications. It has already been approved this year in the EU, Switzerland, Canada, and Australia.At Eli Lilly, Alzheimer's disease, as one of its key research areas, was also showcased at the CIIE. In July this year, Eli Lilly's new drug donanemab-azbt (brand name Kisunla) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of early-stage Alzheimer's disease (AD) patients with mild cognitive impairment.In the Chinese market, the new drug application for donanemab was granted priority review by the CDE in November 2023, intended for the treatment of early Alzheimer's disease. However, a competing product from Japanese pharmaceutical company Eisai, lecanemab, has already been officially launched in China in June 2024.MNCs Increase Investment in the Chinese MarketAt this year's CIIE,Novartis' Innovative Drug Combination for IgA Nephropathy Makes Debut, including the world's firstSmall Molecule Complement Factor B Inhibitor Iptacopan(Ipocapanzine Hydrochloride Capsules) andOral Endothelin A Receptor Antagonist Atrasentan(Atrasentan) has also drawn market attention.It was reported that in January this year, Novartis announced the acquisition of SinnoPharm, a local pharmaceutical company in China, to strengthen its presence in the renal disease sector. The core assets of SinnoPharm include two drugs for the treatment of IgA nephropathy still in clinical development — atrasentan and zigakibart (BION-1301). This marks the first showcase of Novartis' renal disease portfolio at the CIIE since the acquisition.In addition, GlaxoSmithKline (GSK) has also brought many heavy-weight products, such as GSKThe First Long-Acting HIV Pre-Exposure Prophylaxis Drug: Cabotegravir Injection (Apretude), which was approved for marketing by the China National Medical Products Administration this July; as well as GSK's "star" products Shingrix (Recombinant Zoster Vaccine), Cervarix (Bivalent Human Papillomavirus Adsorbed Vaccine), Nucala (Mepolizumab), etc.Haleon, the consumer health company spun off from GSK, also brought 17 new products to this year's CIIE, five of which are global premieres.Takeda's TAK-279 for the treatment of moderate to severe plaque psoriasis in adults and TAK-861 for narcolepsy type 1 also made their debut at this year's CIIE, along withBBM-H901 Injection, the first recombinant adeno-associated virus (AAV) gene therapy drug in China to have successfully submitted a new drug application for marketing authorization。In addition, multinational pharmaceutical giants such as Pfizer, AstraZeneca, and Boehringer Ingelheim also showcased products from various fields at the CIIE. For example, Boehringer Ingelheim's Spevigo®, the world’s first targeted therapy for generalized pustular psoriasis. This drug is a humanized monoclonal antibody that targets the IL-36 receptor and was launched in China in the first half of 2023.Xinkejie learned that due to the fact that many innovative drugs and device products had successfully moved towards clinical application through the CIIE, and even accelerated their entry into the Chinese market, transforming from exhibits into commercial products.Moreover, with the successive introduction of favorable review and approval systems for innovative drugs in China, an increasing number of multinational pharmaceutical companies are also beginning to synchronize the launch of key products in the Chinese market, enhancing their competitive edge in this important market. As a result, many first-launch products have emerged this year, and these products are also expected to gradually enter the Chinese market in the future.Xin Kangjie has compiled information from multiple sources and organized some of the major innovative products showcased by multinational pharmaceutical companies at the 2024 CIIE.
（2024Products showcased by some multinational pharmaceutical companies at the CIIE, Source: Corporate and media reports)
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