Sunshine Nohe CRO Project Special Session: Seeking Partners for Injectable, Transdermal, and Oral Drug Delivery Projects
SunNovo
Drug Research and Development Service Provider
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Beijing Sunshine Nohe Drug Research Co., Ltd. (SunNovo), listed on the STAR Market (Stock Code: 688621), is a comprehensive contract research organization (CRO) specializing in generic and innovative drug research. With technology services at its core, SunNovo is dedicated to advancing the development of China’s pharmaceutical industry by providing clients with end-to-end drug R&D services encompassing “preclinical + clinical + CDMO” stages. By integrating resources from drug discovery, pharmacology and efficacy studies, and pharmaceutical research to clinical trials, establishing bioanalytical testing teams, and consolidating manufacturing capabilities, SunNovo has successfully established a full-process CRO service model.
The company’s core business encompasses comprehensive R&D services covering pharmacology and efficacy evaluation, clinical research, CDMO, innovative drug development, generic drug development, and consistency evaluation. Its service portfolio primarily includes drug discovery, pharmacology and efficacy studies, pharmaceutical research, clinical research, and bioanalysis. The company is capable of providing end-to-end services such as full-cycle chemical drug R&D, generic drug consistency evaluation, drug metabolism analysis and evaluation, peptide drug R&D, clinical bioequivalence trials, Phase I–IV clinical studies, biological sample testing, regulatory submissions (for domestic and imported drugs), and international cooperation.
This issue’s link special brings you11SunNovo CRO Service Projects，RecruitmentEnterprises with R&D Needs, as detailed below:
1、Basic Information
Product Name: Ramelteon Tablets
English Name: Ramelteon
Product Name: Rozerem
Original Manufacturer: Takeda Pharmaceutical Co., Ltd.
Product Specification: 8 mg
Registration Category: Class 3
Ramelteon, approved by the FDA for marketing in the United States in September 2005 under the brand name Rozerem, is indicated for the treatment of sleep-onset insomnia and has demonstrated efficacy in both chronic and short-term insomnia. This agent selectively agonizes melatonin type 1 and type 2 receptors (MT1 and MT2), increasing slow-wave sleep (SWS) and rapid eye movement (REM) sleep, thereby alleviating insomnia. Ramelteon is the first non-addictive insomnia medication not classified as a controlled substance.
Ramelteon is rapidly absorbed, reaching peak plasma concentrations approximately 0.75 hours after oral administration on an empty stomach. Due to extensive first-pass metabolism, the absolute oral bioavailability of ramelteon is only 1.8%. In human serum, the in vitro protein binding rate of ramelteon is approximately 82% and is concentration-independent. Binding to albumin accounts for the majority of this binding, as 70% of the drug binds to human serum albumin. Metabolism primarily involves oxidation into hydroxy and carbonyl derivatives, with secondary metabolism producing glucuronide conjugates. CYP1A2 is the major isoenzyme involved in the hepatic metabolism of ramelteon. Following oral administration of radiolabeled ramelteon, 84% of the total radioactivity is excreted in urine and approximately 4% in feces, with a mean recovery rate of 88%. Less than 0.1% of the dose is excreted as the parent compound in urine and feces. Elimination is essentially complete within 96 hours after dosing. Due to the short elimination half-life of ramelteon (mean approximately 1 to 2.6 hours), once-daily repeated dosing does not result in significant accumulation.
For the treatment of sleep-onset insomnia
No Listed Companies in China
Overseas Marketing Status: In July 2005, ROZEREM tablets were approved in the United States for the treatment of "insomnia characterized by difficulty falling asleep." In Japan, it was approved for production and sales in April 2010 as a drug not classified under "psychotropic substances" or "Caution: Addiction," due to its efficacy in "improving difficulty falling asleep in patients with insomnia." The results of a re-evaluation were announced in June 2019, reaffirming its clinical utility.
Two companies in China have submitted clinical trial applications: Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. and Yuanyang Pharmaceutical Development (Guangzhou) Co., Ltd.
The List of Reference Listed Drugs for Generic Drugs (Batch 30) Released by the National Medical Products Administration is as follows:
Based on the above information, for the formulation and process development of ramelteon tablets, Rozerem, marketed by Takeda Pharmaceutical Company Limited in Japan, may be selected as the reference listed drug. The strength is 8 mg. The manufacturer of the reference listed drug is Takeda Pharmaceutical Company Limited, Drug Consultation Office, with the manufacturing address at 2-1-1 Nihonbashi Honcho, Chuo-ku, Tokyo 103-8668, Japan.
SunNovo possesses mature manufacturing processes for both the active pharmaceutical ingredient (API) and finished dosage forms of ramelteon. The pilot-scale technology transfer for the API has been completed, while the pilot-scale production for the finished dosage forms is imminent.
1. Basic Information
Product Name: Finerenone Tablets
English Name: Finerenone Tablets
Product Name: Kerendia (Kerendia)
Original Manufacturer: Bayer
Product Specifications: 10 mg and 20 mg
Registration Category: Class 4
2. Project Advantages
Finelenone Tablets (generic name: Finelenone, hereinafter referred to as Finelenone) are a novel non-steroidal selective mineralocorticoid receptor antagonist (MRA) developed by Bayer. It is indicated for adult patients with chronic kidney disease associated with type 2 diabetes mellitus (estimated glomerular filtration rate [eGFR] ≥25 to <75 mL/min/1.73 m², with albuminuria) to reduce the risk of sustained eGFR decline and end-stage renal disease.
Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist. MR can be activated by aldosterone and cortisol to regulate gene transcription, and its overactivation leads to fibrosis and inflammation. As a potent and selective MR antagonist, finerenone blocks MR-mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and non-epithelial (e.g., heart and blood vessels) tissues, with no affinity for androgen, progesterone, estrogen, or glucocorticoid receptors.
3. Clinical Indications
Reduce the Risk of End-Stage Renal Disease Associated with Type 2 Diabetes
4. Listing Status
Currently listed only as a reference drug in China, with Bayer as the marketing authorization holder; available in 10 mg and 20 mg strengths.
5. Domestic Filing Status
No companies have applied for an IPO.
6. Market Overview
7. Selection of Reference Listed Drug
Information on the List of Reference Listed Drugs Released by the NMPA:
In summary, Bayer’s originally developed marketed product, under the brand name Kerendia (Keshenda), was selected as the reference listed drug.
8. Patent Status
Compound Patent CN101641352B, with protection expiring on February 19, 2028; CN106795155A, covering the originator API synthesis route, with protection expiring in 2035.
9. R&D Progress
The pre-bioequivalence (pre-BE) study for Finerenone Tablets has been completed, with mature project experience.
1. Basic Information
Product Name: Acetaminophen and Ibuprofen Tablets
English Name: Ibuprofen and Acetaminophen Tablets
Product Name: Advil Dual Action With Acetaminophen
Original Manufacturer: GlaxoSmithKline Consumer Healthcare
Product Specifications: Acetaminophen 250mg, Ibuprofen 125mg
Registration Category: Class 3
2. Project Advantages
Acetaminophen is a commonly used aniline-class antipyretic and analgesic medication. It does not cause allergic reactions or cumulative toxicity in patients. Clinically, it is primarily used to treat headaches and fever, as well as to relieve mild to moderate pain. It is also indicated for the management of headache, fever, and general malaise associated with the common cold and viral infections, and serves as an effective analgesic. Vitamin C enhances the body's resistance to infectious diseases, promotes antibody formation, increases the phagocytic activity of white blood cells, and exhibits anti-inflammatory and anti-allergic effects. Furthermore, it boosts the body's resistance to viruses and its capacity to detoxify harmful substances.
Ibuprofen is a commonly used antipyretic, analgesic, and anti-inflammatory drug. It is primarily indicated in clinical practice for fever reduction and for the relief of joint pain caused by high fever, neuralgia, dysmenorrhea, and pain associated with other conditions. Ibuprofen was jointly discovered by Dr. Stewart Adams and his team, along with chemist Dr. John Nicholson. It emerged from long-term research efforts aimed at developing a “super aspirin” for the treatment of rheumatoid arthritis. The designation of ibuprofen as a “super aspirin” signifies that it offers comparable efficacy to other drugs available at the time, but with an improved safety profile.
3. Clinical Indications
Antipyretic, Analgesic, and Anti-inflammatory.
4. Marketing Authorization Status in China and Abroad
Currently, one domestic company (Guangzhou Nanxin) has listed a compound ibuprofen tablet on the market, with each tablet containing 400 mg of ibuprofen and 325 mg of acetaminophen.
5. Domestic Registration Status
Currently, two companies in China have submitted applications: Shandong Langnuo and Changchun Lanjiang. Both have applied for the specification of 250 mg acetaminophen and 125 mg ibuprofen.
6. Market Sales Performance
Acetaminophen and Ibuprofen Tablets have not yet been launched in China, so there is no sales data available. Ibuprofen Tablets are an OTC product. The following presents partial sample hospital data from our company’s database:
7. Selection of Reference Listed Drugs
NMPA-Released Reference Listed Drug Catalog Information
In summary, in accordance with the requirements of current regulatory guidelines, the original innovator product marketed by GlaxoSmithKline Consumer Healthcare in the United States, under the brand name Advil Dual Action With Acetaminophen (containing 250 mg acetaminophen and 125 mg ibuprofen), is selected as the reference listed drug.
8. Patent Status
No patent restrictions.
9. R&D Progress
Prescription process development is underway.
1. Basic Information
Product Name: Ibuprofen and Phenylephrine Hydrochloride Tablets
English Name: Ibuprofen and Phenylephrine Hydrochloride Tablets
Product Name: Advil Congestion Relief
Original Manufacturer: GlaxoSmithKline Consumer He
Product Specifications: Ibuprofen 200 mg, Phenylephrine Hydrochloride 10 mg
Registration Category: Class 3
2. Project Advantages
Anti-cold medications constitute a vast family and represent the largest category of pharmaceuticals. Based on the different types of vasoconstrictors they contain, anti-cold medications can be classified into three generations:First-generation phenylpropanolamine-based anti-cold medications: Prior to 2000, anti-cold medications both domestically and internationally were predominantly based on phenylpropanolamine (norephedrine, PPA).Second-generation pseudoephedrine-based anti-cold medications: Following the discontinuation of phenylpropanolamine-containing anti-cold medications starting in 2000, countries successively adopted pseudoephedrine to formulate new anti-cold medications.Third-generation phenylephrine-based anti-cold medications: U.S. studies have confirmed the efficacy of oral phenylephrine in vasoconstriction and relief of nasal congestion, thereby establishing its role in anti-cold medications. The original branded product of Ibuprofen and Phenylephrine Tablets was approved by the FDA for market launch in May 2010, having been successfully developed by Pfizer Inc. in the United States. Currently, this product is marketed as an over-the-counter (OTC) drug by GSK as the license holder.
3. Listing Status
No Listed Companies in China
4. Domestic Registration Status
In China, only SunNovo has applied for clinical trials
5. Selection of Reference Listed Drugs
The List of Reference Listed Drugs for Generic Drugs (Batch 29) Released by the National Medical Products Administration is as follows:
Based on the above information, for the formulation and process development of Ibuprofen and Phenylephrine Hydrochloride Tablets, Advil Congestion Relief, marketed by GlaxoSmithKline Consumer Healthcare in the United States, may be selected as the reference listed drug, with a strength of 200 mg ibuprofen and 10 mg phenylephrine hydrochloride.
6. R&D Progress
SunNovo has a mature manufacturing process for Ibuprofen and Phenylephrine Hydrochloride Tablets and is currently preparing for clinical trials.
1. Basic Information
Product Name: Argatroban Injection
English Name: Argatroban Injection
Product Name: NOVASTAN
Original Manufacturer: Tanabe Mitsubishi Pharma Corporation
Product Specification: 2 mL:10 mg
Registration Category: Class 4
2. Project Advantages
Argatroban is an antithrombotic agent developed and synthesized by Mitsubishi Pharma Corporation (formerly Mitsubishi Chemical Corporation’s pharmaceutical division) in Japan. It was first launched in February 1990, initially indicated for the clinical treatment of peripheral arterial occlusive disease. Subsequently, its indications were expanded to include the treatment of acute cerebral thrombosis, adjunctive therapy during thrombolysis for myocardial infarction, and anticoagulation management in patients with antithrombin (AT) deficiency undergoing hemodialysis. In 2000, the U.S. Food and Drug Administration (FDA) approved injectable argatroban, a small-molecule antithrombotic drug developed by Glaxo Wellcome (now part of GSK) and Texas Biotechnology Corporation, for the treatment and prevention of thrombosis and heparin-induced immune thrombocytopenia (HIT), as well as for use in patients undergoing percutaneous coronary intervention (PCI). Argatroban was launched in South Korea in 2001. In December 2002, Mitsubishi Pharma officially introduced argatroban to the Chinese market under the brand name Novastan, with a specification of 2 mL:10 mg.
3. Listing Status
Currently, there are 26 marketed products in China, including one reference listed drug and 23 that have passed the consistency evaluation. This product has been included in the centralized procurement program. Partial marketing status is as follows:
4. Domestic Filing Status
Currently, seven domestic companies have filed for IPOs, including Hunan Hengsheng, Zhejiang Huahai, and Huaxia Shengsheng.
5. Market Overview
6. Selection of Reference Listed Drugs
NMPA-Released List of Reference Listed Drugs:
In summary, the original drug marketed in China by Mitsubishi Tanabe Pharma Corporation, with the brand name NOVASTAN (Nuobaositai), was selected as the reference listed drug.
7. Patent Status
No patent restrictions.
8. R&D Progress
SunNovo possesses a mature manufacturing process for Argatroban Injection, has obtained the production approval, and is available for out-licensing.
1. Basic Information
Product Name: Dutasteride Soft Capsules
English Name: Dutasteride Soft Capsules
Product Name: Avodart (Anfuda)
Original Manufacturer: GlaxoSmithKline (Ireland) Ltd.
Product Specification: 0.5 mg
Registration Category: Class 4
Patent Status: No Patent Restrictions
2. Project Advantages
Dutasteride (Avodart, GlaxoSmithKline) is a second-generation 5α-reductase inhibitor and the first and only drug currently available that simultaneously inhibits both type I and type II 5α-reductase. Approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States in 2001, it is indicated for the treatment of benign prostatic hyperplasia (BPH). Long-term administration reduces prostate volume; therefore, the FDA has approved its use to reduce the risk of acute urinary retention and related surgical interventions. It is marketed under the brand name Avolvet in Europe.
On April 11, 2011, the State Food and Drug Administration approved the import marketing application for dutasteride soft capsules (brand name: Avodart; strength: 0.5 mg) manufactured by Laboratoire GlaxoSmithKline of France, with the Import Drug Registration Certificate Number H20110205.
3. Clinical Indications
Treatment of Benign Prostatic Hyperplasia.
4. Listing Status
Currently, six companies in China have this product listed: one as a reference drug and five having passed the generic quality consistency evaluation. This product has been included in the centralized procurement program.
5. Domestic Application Status
Currently, there are no new applicant enterprises.
6. Selection of Reference Listed Drugs
Information on the Reference Listed Drug Catalog Published by the NMPA:
In summary, the original drug marketed in China by GlaxoSmithKline (Ireland) Ltd., under the brand name Avodart (安福达), is selected as the reference listed drug.
7. R&D Progress
SunNovo has a mature preparation process for dutasteride soft capsules, has obtained the production approval, and is available for external transfer.
1. Basic Information
Product Name: Doxycycline Hyclate Tablets
English Name: Doxycycline Hyclate Tablets
Product Name: Vibramycin
Original Manufacturer: Pfizer Japan Inc.
Product Specification: 0.1g
Registration Category: Class 3
2. Project Advantages
Doxycycline is a tetracycline antibiotic commonly used to treat various infections. It is a broad-spectrum antibiotic and bacteriostatic agent. Doxycycline possesses antiprotozoal properties and is an effective inhibitor of matrix metalloproteinases (MMPs) in vivo. Doxycycline is frequently used to treat Lyme disease, chronic prostatitis, sinusitis, pelvic inflammatory disease, acne, rosacea, and rickettsial infections, as well as for the prophylaxis and treatment of anthrax (caused by Bacillus anthracis). It is also effective against Yersinia pestis. Its therapeutic effects are associated with the inhibition of collagen synthesis by doxycycline.
3. Clinical Indications
Superficial skin infections, deep skin infections, lymphangitis and lymphadenitis, chronic pyoderma, secondary infections of traumatic wounds, burns, and surgical incisions, mastitis, osteomyelitis, laryngopharyngitis, tonsillitis, acute bronchitis, pneumonia, and other infections caused by these conditions.
4. Listing Status
Currently, there are 61 marketed products in China, with only Jiangsu Lianhuan having passed the consistency evaluation. The marketing status of some products is as follows:
5. Domestic Application Status
Currently, two companies in China have submitted applications: Teyi Pharmaceutical has applied for consistency evaluation, and Zhejiang Saimo has applied for market approval.
6. Market Overview
7. Selection of Reference Listed Drug
Information on the List of Reference Listed Drugs Released by the NMPA:
In summary, Pfizer Japan Inc.’s original drug marketed in Japan, under the brand name Vibramycin, was selected as the reference listed drug.
8. Patent Status
No patent restrictions.
9. R&D Progress
Adapalene and Benzoyl Peroxide Gel is undergoing pilot-scale production, with mature project experience.
1. Basic Information
Product Name: Nemonoxacin Malate Capsules
English Name: Nemonoxacin Malate Capsules
Product Name: Taijiexin
Original Manufacturer: Xinchang Pharmaceutical Factory, Zhejiang Medicine Co., Ltd.
Product Specification: 0.25g
Registration Category: Class 4
2. Project Advantages
Nemonoxacin (TG-873870) exhibits broad-spectrum in vitro antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, and atypical pathogens, including penicillin-resistant and quinolone-resistant Streptococcus pneumoniae. It is also effective against methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus, and multidrug-resistant pathogens. The presence of an additional methyl group at the C-8 position of nemonoxacin, compared to conventional quinolones, enables binding to both topoisomerase IV and II, thereby broadening its antibacterial spectrum and reducing the induction of resistance.
Nemonoxacin is a novel C-6 non-fluorinated quinolone developed by TaiGen Biotechnology (Taiwan) under license from Procter & Gamble (P&G) Pharmaceuticals. TaiGen has authorized Zhejiang Medicine Co., Ltd. to manufacture and market the drug in mainland China. The currently used formulation is nemonoxacin malate. Compared with conventional quinolone antibiotics, nemonoxacin exhibits higher antibacterial activity against Gram-positive cocci.
3. Clinical Indications
Anti-Bacterial Infection
4. Listing Status
Currently, only one company has marketed nemonoxacin malate capsules in China: Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory (originator), with a strength of 0.25 g (calculated as C20H25N3O4). The marketing status is as follows:
5. Domestic Filing Status
No generic drug marketing applications have been filed by any companies.
In January 2023, Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory (originator) submitted an application for clinical trials.
In June 2023, the Phase III clinical trial for the treatment of uncomplicated urinary tract infections was ongoing.
6. Market Overview
Sales data for Nemonoxacin Malate Capsules are as follows:
7. Selection of Reference Listed Drug
NMPA-Released List of Reference Listed Drugs:
In summary, the domestically marketed nemonoxacin malate capsules of the originator drug (Marketing Authorization Holder: Xinchang Pharmaceutical Factory of Zhejiang Medicine Co., Ltd.; brand name: Taijiexin) may be selected as the reference listed drug.
8. Patent Status
9. R&D Progress
SunNovo is currently conducting laboratory formulation and process research.
1. Basic Information
Product Name: Adapalene and Benzoyl Peroxide Gel
English Name: Adapalene and Benzoyl Peroxide Gel
Product Name: Epiduo
Original Manufacturer: Laboratoires Galderma S.A.
Product Specifications: 0.1%, 2.5% (15 g)
Registration Category: Class 3 → Class 4
2. Project Advantages
Adapalene is a third-generation retinoid and a naphthoic acid derivative. It exhibits specific affinity for retinoic acid nuclear receptors. Unlike first-generation retinoids such as tretinoin and isotretinoin, adapalene does not bind to cellular retinoic acid-binding proteins, resulting in lower skin irritation compared to earlier retinoid formulations. Furthermore, its superior stability eliminates the limitation of nighttime-only application associated with tretinoin, which is photosensitive and requires protection from light.Benzoyl peroxide (BPO) is a benzoic acid derivative with broad-spectrum antibacterial activity, particularly against anaerobic infections. It demonstrates antibacterial efficacy against Cutibacterium acnes (formerly Propionibacterium acnes) and Staphylococcus epidermidis, and also possesses keratolytic properties. Its most notable characteristic is the lack of development of bacterial resistance. According to research findings from the original patent CN101541320B, BPO can enhance the efficacy of adapalene. Combination therapy with adapalene and BPO successfully reduces acne lesions and improves clinical symptoms in patients while maintaining comparable skin tolerability. This combined approach demonstrates significantly superior therapeutic efficacy compared to monotherapy with either adapalene or BPO alone.
3. Clinical Indications
Topical Treatment of Acne Vulgaris
4. Listing Status
No adapalene/benzoyl peroxide gel is currently marketed in China. Monotherapy formulations, including adapalene gel and benzoyl peroxide gel, are available on the market, with the following marketing status:
5. Domestic Application Status
Currently, there are two applicants for market approval in China: the originator Galderma and Suzhou Gaomai.
In January 2023, the originator Galderma filed for marketing approval, with approval expected by late 2024 or early 2025.
6. Market Overview
As the adapalene/benzoyl peroxide gel has not yet been launched in China, there are currently no sales data available for the combination product.
Sales data for adapalene gel monotherapy and benzoyl peroxide gel monotherapy are as follows:
7. Selection of Reference Listed Drugs
NMPA-Released List of Reference Listed Drugs:
In summary, select the original branded drug marketed by Laboratoires Galderma S.A., under the trade name: Epiduo.
8. Patent Status
No patent restrictions.
9. R&D Progress
Adapalene and Benzoyl Peroxide Gel is undergoing pilot-scale production, with mature project experience.
1. Basic Information
Product Name: Dotinurad Tablets
English Name: Dotinurad Tablets
Product Name: URECE
Original Manufacturer: Fuji Yakuhin Co., Ltd.
Product Specifications: 0.5 mg, 1 mg, 2 mg
Registration Category: Class 3
2. Project Advantages
Dotinurad Tablets (generic name: dotinurad) are a selective URAT1 inhibitor developed by Fuji Yakuhin Co., Ltd. As a Selective Urate Reabsorption Inhibitor (SURI), the drug is designed to minimize hepatic toxicity (such as mitochondrial toxicity) and drug interactions caused by CYP2C9 inhibition.
Development of dotinurad tablets began in 2009. Clinical trials for patients with gout and hyperuricemia were conducted by Fuji Yakuhin Co., Ltd., while the Phase III trials were jointly conducted by Fuji Yakuhin Co., Ltd. and Mochida Pharmaceutical Co., Ltd. Following confirmation of the efficacy and safety of dotinurad tablets, an application was submitted for the indications “gout” and “hyperuricemia.” Marketing and manufacturing approval was granted on January 23, 2020, under the brand name URECE, available in strengths of 0.5 mg, 1 mg, and 2 mg. Persistent hyperuricemia can lead to gouty arthritis (gout) and result in a reduced quality of life. Furthermore, hyperuricemia is associated not only with gout but also with the risk of renal impairment and cardiovascular events. Therefore, lowering serum uric acid levels in patients with gout and hyperuricemia is of critical importance. In the management of gout and hyperuricemia, lifestyle modifications constitute the fundamental principle, and pharmacological therapy is equally important.
3. Clinical Indications
Gout, Hyperuricemia
4. Listing Status
Currently, there are no listed companies in China.
5. Domestic Application Status
The original innovator’s Phase III clinical trial in China has been completed, with market launch imminent (the strengths studied in the clinical trials were 1 mg and 2 mg).
6. Market Overview
Not yet marketed in China, so there is currently no sales data.
7. Selection of Reference Listed Drug
Information on the Reference Listed Drugs Catalog Released by the NMPA:
In summary, the original drug marketed in Japan by Fuji Yakuhin Co., Ltd., under the brand name URECE, was selected as the reference listed drug.
8. Patent Status
9. R&D Progress
Dotinurad API is undergoing pilot-scale preparation, while the formulation is in the laboratory research phase.
1. Project Advantages
Landiolol Hydrochloride for Injection is an injectable pharmaceutical formulation developed by Ono Pharmaceutical of Japan for the treatment of tachyarrhythmias. It is a novel ultra-short-acting beta-adrenergic receptor blocker. Beta-adrenergic receptor blockers are a class of widely used and important cardiovascular therapeutic agents. Due to their rapid onset of action, rapid metabolism, and swift disappearance of beta-blocking effects after discontinuation, ultra-short-acting beta-adrenergic receptor blockers play a crucial and irreplaceable role in the management of tachyarrhythmias.
2. Clinical Indications
1) Emergency treatment of the following tachyarrhythmias occurring during surgery: atrial fibrillation, atrial flutter, and sinus tachycardia;
2) Emergency treatment of tachyarrhythmias occurring during dynamic monitoring of the circulatory system after surgery: atrial fibrillation, atrial flutter, and sinus tachycardia;
3) Treatment of the following tachyarrhythmias in patients with cardiac insufficiency: atrial fibrillation, atrial flutter;
No originator products are marketed in China; only one generic drug is available.
3. Project Progress
SunNovo Completes Process Validation for Landiolol API; Formulation Process Validation Imminent.
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