Novo Nordisk to Acquire Three Catalent Manufacturing Facilities for $11.7 Billion to Bolster Global GLP-1 Production Capacity

On December 14, 2024, Novo Nordisk announced that the acquisition of Catalent by Novo Holdings, as well as Novo Nordisk's subsequent acquisition of three production sites from Novo Holdings, have both received regulatory approval.

The acquisition is expected to have a low single-digit negative impact on Novo Nordisk's financial outlook for 2024, affect operating profit growth, and negatively impact free cash flow at an acquisition price of USD 11.7 billion. The ongoing share repurchase program of DKK 20 billion remains unaffected.

2024-12-13, AbbVie and Nimble announced a definitive agreement whereby AbbVie will acquire Nimble, including its lead asset, a preclinical oral peptide IL23R inhibitor for the treatment of psoriasis, as well as a series of other novel oral peptide candidates potentially targeting various autoimmune diseases.

In addition, AbbVie will also acquire Nimble's peptide synthesis, screening, and optimization platform, which uses proprietary technology to help rapidly discover and optimize candidate peptides for a range of targets.

2024-12-09, Protagonist Therapeutics announced the final results of its Phase II REVIVE study of the investigational drug Rusfertide in patients with polycythemia vera (PV).

Data show:

54% of patients achieved durable hematocrit (Hct) control (<45%) for over 2.5 years, reducing the use of phlebotomy, demonstrating good long-term tolerability, and improving patient-reported outcomes;

Rusfertide, as a supplement to therapeutic phlebotomy, can durably control Hct below the 45% threshold within 3 years, whether or not combined with cytoreductive therapy.

In all parts of the study, the average phlebotomy rate (EPHL) for patients was less than once per year, demonstrating a significant reduction in phlebotomy requirements associated with Rusfertide treatment;

Platelet levels increased and stabilized over time after Rusfertide treatment, while white blood cell counts remained stable throughout the study period.

In patients with moderate or severe symptoms at baseline, individual symptom scores for fatigue, early satiety, abdominal discomfort, reduced activity, attention problems, night sweats, and itching showed significant improvement from baseline to the end of Part 3;

26% of patients experienced serious adverse events (SAEs), most of which were related to underlying diseases and showed no obvious association with Rusfertide.

Among them, Rusfertide is a peptide drug that mimics the natural hormone hepcidin, currently in Phase III studies for the treatment of polycythemia vera. Protagonist Therapeutics has partnered with Takeda Pharmaceutical to develop and commercialize Rusfertide. According to the global collaboration and licensing agreement signed in 2024, Protagonist is mainly responsible for the development work prior to the NDA submission.

2024-12-10, Theratechnologies announced positive data from the Phase Ib dose-escalation trial of its investigational drug Sudocetaxel Zendusortide (TH1902) in patients with advanced ovarian cancer.

Data shows:

In the two weekly dosing regimens (Group A: 1.75 mg/kg and Group B: 2.5 mg/kg), no dose-limiting toxicity (DLT) was observed, demonstrating good tolerability.

In the 2.5 mg/kg dose group, three patients showed significant efficacy, with one case of complete regression of liver lesions, two cases of tumor volume reduction exceeding 25%, accompanied by a significant decrease in the CA-125 tumor marker.

Patients in the 2.5 mg/kg dose group had a longer average treatment duration (10.25 weeks on average, compared to 7.6 weeks in the 1.75 mg/kg dose group).

Among them, Sudocetaxel Zendusortide is a peptide-drug conjugate (PDC) targeting sortilin (SORT1). It combines a specific peptide with the chemotherapeutic drug docetaxel through a cleavable linker. Docetaxel is a well-established cytotoxic chemotherapy drug used to treat SORT1-associated advanced solid tumors. SORT1 is a "scavenger" receptor that is highly expressed in various tumors (such as ovarian cancer, triple-negative breast cancer, and pancreatic cancer) and is associated with poor prognosis and dyslipidemia, making it an important target for anticancer drug development.

FDA Grants Fast Track Designation to Sudocetaxel Zendusortide for SORT1-Positive Advanced Refractory Solid Tumors That Fail Standard Therapies. Theratetechnologies Plans to Leverage Its SORT1+ Technology™ Platform to Develop More Innovative Peptide-Drug Conjugates and Accelerate Partnership Efforts to Advance the Further Commercialization of Its Oncology Programs.

On December 10, 2024, Zealand Pharma announced the completion of the first subject dosing in the Phase IIb ZUPREME-1 trial of Petrelintide in overweight or obese patients.

ZUPREME-1 is a randomized, double-blind, placebo-controlled Phase IIb clinical trial designed to evaluate the efficacy of different doses of Petrelintide in patients who are obese or overweight with weight-related complications. The trial includes a screening period, a 16-week dose-escalation period with dose increases every 4 weeks, followed by a maintenance period until Week 42, and a follow-up period after treatment completion until Week 51. A total of 480 participants are planned to be recruited in the United States, Poland, and Romania. The primary endpoint is the percentage change in body weight from baseline to Week 28, including but not limited to changes in body weight, waist circumference, HbA1c, hsCRP, blood lipids, and blood glucose from baseline to Week 42. The trial will ensure gender balance, with no more than 60% of participants being of either sex.

Among them, Petrelintide is a long-acting islet amyloid polypeptide analog suitable for once-weekly subcutaneous administration. It exhibits chemical and physical stability at neutral pH, minimizing fibrillation and allowing co-formulation with other peptides. Islet amyloid polypeptide is produced in pancreatic β-cells and co-secreted with insulin in response to ingested nutrients. Current clinical or preclinical data indicate that petrelintide has weight-loss potential comparable to GLP-1 receptor agonists but with better tolerability, improving patient experience and enabling high-quality weight loss by preserving lean body mass.

2024-12-10, Lisata, which focuses on developing innovative therapies for advanced solid tumors and other severe diseases, announced the completion of patient enrollment in the Phase 1b/2a CENDIFOX trial. The trial is evaluating the safety and efficacy of Lisata’s iRGD cyclic peptide candidate Certepetide in combination with Folfirinox-based therapy for pancreatic cancer, colon cancer, and appendiceal cancer.

Among them, Certepetide is an investigational drug designed to selectively activate the C-end rule-mediated active transport mechanism in a tissue-specific manner, thereby enabling more efficient penetration and accumulation of systemically co-administered drugs within tissues. To date, in completed and ongoing oncology clinical trials aimed at enhancing the efficacy of standard-of-care chemotherapy for pancreatic cancer and exploring combination regimens of chemotherapy and immunotherapy for various solid tumors, Certepetide has demonstrated favorable safety, tolerability, and clinical activity. Beyond its potential in oncology, Certepetide’s unique mechanism of action holds exploratory potential in multiple non-oncology fields. Its ability to selectively target specific tissues may offer new therapeutic possibilities for a range of diseases. Certepetide has received Fast Track designation (United States) and Orphan Drug designation for pancreatic cancer (United States and European Union), as well as Orphan Drug designation for glioma, osteosarcoma, and cholangiocarcinoma (United States). Additionally, Certepetide has been granted Rare Pediatric Disease designation for osteosarcoma (United States).

On December 11, 2024, Huadong Medicine's subsidiary, Sinopharm Huadong, registered a clinical trial on the China National Drug Clinical Trial Registry Platform (CTR) for "Semaglutide Injection" for long-term weight management in adult patients based on reduced calorie diet and increased physical activity.

Among them, semaglutide is a long-acting GLP-1 analog that shares 94% homology with the amino acid sequence of natural GLP-1 and acts as a GLP-1 receptor agonist.

In April 2021, the semaglutide injection was approved in China for the treatment of type 2 diabetes (brand name: Novo Nordisk's Ozempic).

January 2024: Semaglutide tablets were approved for marketing in China for the treatment of type 2 diabetes, marking the first orally-administered GLP-1 receptor agonist to be approved in China (brand name: Novoheart, Rybelsus);

In June 2024, the semaglutide injection was approved in China for long-term weight management (brand name: Novo Nordisk's Wegovy).

On December 12, 2024, Novo Nordisk announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion on updating the label for Ozempic® (semaglutide injection). This recommendation was based on data from the FLOW renal outcomes trial.

Trial data show,

Compared with placebo, 1.0mg semaglutide significantly reduced the risk of kidney disease progression by 24%, as well as the risk of cardiovascular and renal death. In addition, the secondary endpoints in the trial showed an 18% reduction in the risk of major cardiovascular events and a 20% reduction in the risk of all-cause mortality.

On December 12, 2024, Gan & Lee Pharmaceuticals announced that it had received approval from the U.S. FDA to initiate a Phase II clinical trial of GZR18 injection. This trial will conduct a head-to-head comparison with Eli Lilly's tirzepatide. The relevant IND application number is 171618.

Among them, GZR18 is a long-acting GLP-1 RA that functions through a glucose concentration-dependent mechanism, enhancing insulin secretion and effectively reducing blood glucose levels. GZR18 is available in two administration methods: injection and oral. The GZR18 injection is a GLP-1RA based on fatty acid acylation design, with 94% homology to the human GLP-1 molecule. It is intended for glycemic control in adult patients with type 2 diabetes and weight management in obese or overweight patients. Currently, it is undergoing Phase II clinical trials in China, and the first subject has already been dosed. The GZR18 tablet utilizes reversible binding technology with the small-molecule absorption enhancer SNAC (N-[8-(2-hydroxybenzoyl) amino] caprylate). While ensuring safety and efficacy, this technology addresses issues such as low bioavailability and suboptimal effectiveness of orally administered peptide-based GLP-1 RAs, while also improving patient compliance. Its indication is for type 2 diabetes, and it has completed Phase I clinical trials.

On December 12, 2024, Shanghai Minwei Biotech registered a clinical trial for "MWN105 Injection" targeting type 2 diabetes, overweight, or obesity on the China Drug Clinical Trial Registration and Information Platform (CTR).

Among them, MWN105 injection is a GIP/GLP-1/FGF21 tri-target fusion protein, and its indications are mainly for overweight or obesity and type 2 diabetes.

On December 12, 2024, Shanghai Minwei Biotech registered a clinical trial for "MWN109 Injection" targeting type 2 diabetes, overweight, or obesity on the China Drug Clinical Trial Registration and Information Platform (CTR).

Among them, MWN109 Injection, developed by Shanghai Minwei Biotechnology, is a novel GIP/GLP-1/GCG tri-target peptide drug designed to improve metabolic conditions through multiple mechanisms. The drug's development is based on Minwei Biotechnology’s extensive experience in GLP-1 multi-target drug development, utilizing an internally established GPCR agonist screening platform and the RAF™ ultra-long-acting molecular development platform to discover and optimize candidate drugs through high-throughput screening.

On December 12, 2024, Grand Pharmaceutical registered a clinical trial on the China Drug Trial Registration and Information Disclosure Platform (CTR) for "Lutetium [177Lu] Edotreotide Injection" in patients with well-differentiated aggressive grade 2 and 3, somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors.

Among them, Lutetium [177Lu] Edotreotide (177Lu-edotreotide), also known as ITM-11, is a targeted therapeutic drug based on Radiopharmaceutical Conjugation Technology (RDC), mainly used for the treatment of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs). The drug conjugates carrier-free 177Lu with a somatostatin analog, leveraging its binding with somatostatin receptors (SSTR) highly expressed on the surface of GEP-NETs to achieve targeted killing of tumor cells. Compared with 177Lu radionuclide products containing carriers, carrier-free 177Lu has higher specific activity and purity, generates fewer long half-life impurities during production, and causes less radioactive contamination. Globally, this drug has entered Phase III clinical research, and it is also in Phase III clinical research in China. In addition, Lutetium [177Lu] Edotreotide has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), indicating its significant clinical value and potential in treating GEP-NETs.

2024-12-12, Revolo, dedicated to developing and providing therapies that restore immune system homeostasis, announced the latest preclinical data for '1104. The data shows that, in an allergen-driven atopic dermatitis (AD) model, subcutaneous administration effectively reduces key markers of skin inflammation and inflammatory mediators compared to intravenous administration, with excellent local tolerability.

Among them, '1104 is a first-in-class peptide involved in restoring immune homeostasis. Revolo has recently advanced '1104 through two Phase IIa trials: one in patients with eosinophilic esophagitis (EoE) and the other in allergen-sensitive patients, while also exploring its potential for other allergic conditions. Revolo plans to move a differentiated subcutaneous formulation into clinical studies for EoE and other Type 2 allergic diseases.

2024-12-12, PeptiDream, which focuses on the development of innovative macrocyclic peptide drugs, announced its second wholly-owned radiolabeled peptide candidate, PD-29875, for potential diagnosis and treatment of gastric cancer.

Among them, PD-29875 is a novel highly selective macrocyclic peptide-radioisotope (RI) conjugate that targets Claudin 18.2. Claudin is a member of the Claudin protein family and a component of tight junctions in epithelial tissues. CLDN18.2 is expressed in various solid tumors, including gastric cancer, pancreatic cancer, biliary tract cancer, genitourinary system cancer, colorectal cancer, etc.

2024-12-13, Bicycle, which focuses on pioneering novel differentiated therapies through its proprietary bicyclic peptide technology, presented the latest data on Zelenectide Pevedotin at the SABCS (San Antonio Breast Cancer Symposium) held in Texas, USA.

Including:

Latest Data on Enhanced Antitumor Activity of Zelenectide Pevedotin Monotherapy in Breast Cancer Patients with NECTIN4 Gene Amplification;

Topline Combination Data of Zelenectide Pevedotin with Pembrolizumab for Previously Untreated (First-Line) Cisplatin-Ineligible Metastatic Urothelial Carcinoma (mUC) Patients, Providing Enrollment and Timeline Updates from the Company’s Phase 2/3 Duravelo-2 Trial;

Topline Monotherapy Data for Zelenectide Pevedotin in Treating Non-Small Cell Lung Cancer (NSCLC) Patients with NECTIN4 Gene Amplification.

Among them, Zelenectide Pevedotin (also known as BT8009) is a high-selectivity investigational bicyclic peptide conjugate drug (BTC). It consists of a highly selective bicyclic peptide targeting Nectin-4, linked via a cleavable linker to the cell-penetrating toxin monomethyl auristatin E (MMAE). Compared with antibody-drug conjugates, BT8009 has a lower molecular weight and shorter plasma half-life, which may allow for rapid tumor penetration while minimizing exposure to healthy tissues (reducing exposure of healthy tissues and bystander toxicity). Bicyclic peptides represent a potential new treatment modality for cancer and other diseases.

On December 9, 2024, Fujian Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, registered a Phase I clinical study on the China Drug Clinical Trial Registration and Information Platform (CTR). The study aims to evaluate the gastric emptying delay effect of HRS9531 injection and its drug-drug interactions with metformin, atorvastatin, warfarin, and digoxin in healthy subjects.

Among them, HRS9531 is a novel GLP-1/GIP dual receptor agonist, which can enhance insulin secretion, suppress appetite, and improve insulin sensitivity by activating the GLP-1 and GIP receptor signaling pathways, thereby helping to lower blood glucose and reduce body weight.

On December 7, 2024, the CDE website showed that the marketing application for Novo Nordisk's "Icodec Insulin Semaglutide Injection" has been accepted.

Among them, the insulin icodec and semaglutide injection is a compound preparation that combines the dual advantages of insulin icodec and semaglutide. Insulin icodec, as a human insulin analog, mainly extends its half-life through reversible binding with albumin, achieving more stable blood glucose control. Semaglutide is a GLP-1 analog that promotes insulin secretion in a glucose concentration-dependent manner, inhibits glucagon secretion, delays gastric emptying to increase satiety, and suppresses appetite by inhibiting the hypothalamic feeding center, thereby achieving the effects of lowering blood sugar and reducing weight.

On December 7, 2024, the CDE official website showed that the clinical trial application for "HDM1005 Injection" from Sinopharm Huadong Pharmaceutical's Sino-American Huadong has been accepted.

Among them, DM1005 Injection is a long-acting GLP-1/GIP agonist independently developed by Huadong Medicine with global intellectual property rights, demonstrating significant efficacy. Preclinical studies have shown that HDM1005 can promote the production of cyclic adenosine monophosphate (cAMP) by activating GLP-1 and GIP receptors, increase insulin secretion, suppress appetite, delay gastric emptying, and improve lipid metabolism, offering effects in blood sugar reduction, weight loss, and the treatment of MASH. Meanwhile, current data indicate that HDM1005 has favorable drug-like properties and safety.

On December 11, 2024, the CDE official website showed that Neuraly's "DD01 Injection" has received the tacit approval for clinical trials from the CDE. It is intended for weight management in adult obese patients or overweight patients with one or more weight-related risk factors (such as hypertension, type 2 diabetes, or dyslipidemia, etc.).

Among them, DD01 injection is a long-acting GLP-1R/GCGR dual agonist, with drug targets being GCGR (glucagon receptor) and GLP-1R (glucagon-like peptide-1 receptor). The indications under research for DD01 injection include non-alcoholic steatohepatitis (NASH), obesity, and type 2 diabetes (T2D). The drug selectively activates the GLP-1 receptor and GCGR receptor, stimulating downstream pathways to produce biological effects such as lowering blood glucose, reducing body weight, decreasing liver fat, reducing serum cholesterol, and improving liver function.

On December 11, 2024, the CDE official website showed that the marketing application for Livzon Group's "Teicoplanin for Injection" has been accepted.

Among them, Teicoplanin (TEC) is a glycopeptide antibiotic used to treat infections caused by Gram-positive bacteria and is also utilized for treating MRSA (methicillin-resistant Staphylococcus aureus) infections. Compared with vancomycin, teicoplanin has equivalent efficacy but better tolerability and a lower risk of adverse reactions. A systematic review found that, compared with vancomycin, teicoplanin significantly reduces nephrotoxicity and the symptoms of red man syndrome. Teicoplanin is highly bound to plasma albumin and has a long elimination half-life, ranging from 83 to 163 hours. Due to its pharmacokinetic (PK) characteristics, there can be significant variation and fluctuation in teicoplanin concentrations when using fixed-dose regimens.

On December 12, 2024, the CDE official website showed that the clinical trial application for "ZX2021 Injection" by Jiangsu Zhongxin Pharmaceuticals had been accepted.

Among them, ZX2021 Injection, developed by Jiangsu Zhongxin Pharmaceutical, is an innovative biologic drug that belongs to the Fc-fusion GLP-1/GIP/GCG triple receptor agonist category. The main indications for this drug are type 2 diabetes, obesity, and overweight. ZX2021 has potential therapeutic effects on blood glucose control and weight management by activating glucagon-like peptide (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and glucagon (GCG) receptors.

In preclinical studies, ZX2021 demonstrated significant weight loss and glucose-lowering effects. Compared with the marketed single-target drug Dulaglutide, ZX2021 showed better weight loss and lipid-lowering effects at the same dose. In addition, ZX2021 is the sixth GLP-1R/GIPR/GCGR triple agonist to enter clinical trials globally and the second such drug in China.

2024-12-12, the CDE official website showed that the listing application for "Acetate Lanreotide Sustained-Release Injection (Pre-filled)" by Sichuan Huiyu Pharmaceutical has been accepted.

Among them, Lanreotide Acetate Sustained-Release Injection (Prefilled) is a somatostatin analog primarily used to treat acromegaly. This medication helps control and reduce the levels of growth hormone and insulin-like growth factor-1 (IGF-1) in the blood by mimicking the action of somatostatin, especially when these levels remain abnormal after surgery and radiotherapy. In addition, Lanreotide Acetate Sustained-Release Injection (Prefilled) also offers convenient administration due to its prefilled design, simplifying the usage process for patients.

On December 7, 2024, the CDE website showed that the marketing application for Novo Nordisk's "Icodec Insulin Semaglutide Injection" has been accepted.

Among them, the insulin icodec and semaglutide injection is a compound preparation that combines the dual advantages of insulin icodec and semaglutide. Insulin icodec, as a human insulin analog, primarily achieves more stable blood glucose control by reversibly binding to albumin, thereby prolonging its half-life. Semaglutide, on the other hand, is a GLP-1 analog that promotes insulin secretion in a glucose concentration-dependent manner, inhibits glucagon secretion, delays gastric emptying to increase satiety, and suppresses appetite by inhibiting the hypothalamic feeding center, thus achieving both glucose-lowering and weight-reducing effects.

On December 7, 2024, the CDE official website showed that the clinical trial application for "HDM1005 Injection" from Sinopharm Huadong Pharmaceutical's subsidiary, Sino-American Huadong, has been accepted.

Among them, DM1005 Injection, a long-acting GLP-1/GIP dual agonist independently developed by Huadong Medicine with global intellectual property rights, has demonstrated promising efficacy. Preclinical studies show that HDM1005 can promote the production of cyclic adenosine monophosphate (cAMP) by activating GLP-1 and GIP receptors, increase insulin secretion, suppress appetite, delay gastric emptying, and improve lipid metabolism, showing effects in lowering blood glucose, reducing weight, and treating MASH. Meanwhile, current data indicate that HDM1005 possesses good drug-like properties and safety.