Today's Drug Approvals: Hengrui, Johnson & Johnson Among Key Players

On November 12, the official website of the National Medical Products Administration (NMPA) announced that Hengrui Pharma's injectable Remimazolam Tosilate has received a new indication, and its Tafluprost Eye Drops have also been approved for marketing, successfully achieving the first generic version of this product in China; additionally, Johnson & Johnson's Daratumumab and Hunan Zhengtai Jinhu Pharmaceutical Co.,Ltd.'s Tenofovir Alafenamide Fumarate Tablets were also approved simultaneously.

Among them, tafluprost ophthalmic solution is an anti-glaucoma drug widely used in clinical practice; daratumumab injection is the first drug approved in China to target the CD38 antibody, mainly used for the treatment of myeloma patients; tenofovir alafenamide fumarate is the only new hepatitis B drug approved by the FDA in nearly 10 years, and is known as a "wonder drug" for hepatitis B.

Screenshot from NMPA

1. Remimazolam Tosilate for Injection

Remimazolam tosylate (Ruibeining) is a modification by Hengrui Pharma based on midazolam, with an added methyl propionate side chain.Acts directly on GABAa receptors to exert sedative effects.Clinical studies have shown that: In the process of gastroscopy and colonoscopy diagnosis and treatment, the sedation success rate of Remimazolam Tosilate is equivalent to Propofol, and recovery is faster. In addition, the incidence of hypotension and respiratory depression with Remimazolam Tosilate is significantly lower than with Propofol, with no serious adverse reactions occurring, demonstrating better safety.

In December 2019, the NMPA officially approved the sedation indication of Remimazolam Tosilate for gastroscopy; in June 2020, the second sedation indication for colonoscopy diagnosis and treatment was approved for marketing; today, Remimazolam Tosilate has achieved its third indication.

It is worth mentioning that Hengrui Pharma has submitted multiple marketing applications for Remimazolam Tosilate. With the continuous approval of new indications, the drug's future sales peak is expected to reach 2 billion yuan. However, Remimazolam Tosilate currently faces competition from Renfu Pharma’s Remimazolam Benzenesulfonate, which was approved in China in July 2020 for sedation during colonoscopy.

2. Tafluprost Eye Drops

It is reported that Tafluprost, a prostaglandin analog developed by Santen Pharmaceutical Co., Ltd. of Japan, is a selective FP prostaglandin receptor agonist. It can reduce intraocular pressure by increasing the aqueous humor outflow through the uveoscleral pathway and is used to lower elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension.

In October 2008, tafluprost ophthalmic solution was approved for marketing in Japan. In July 2015, it was officially approved for marketing in China, and in 2019, it entered the national medical insurance negotiation directory, becoming a widely used antiglaucoma drug in clinical practice. Today, the first generic version of tafluprost ophthalmic solution has also been successfully launched in China.

Data from MiNeiNet shows that in recent years, the terminal sales of tafluprost in China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) have continued to increase, with sales exceeding 30 million yuan in the first half of 2021.An increase of 299.38% year-on-year。

3. Daratumumab

Johnson & Johnson's Daratumumab is the world's first approved CD38-mediated, a cytolytic antibody drug with broad-spectrum killing activity, can specifically target and bind to the highly expressed transmembrane ectoenzyme CD38 molecule on the surface of multiple myeloma and various solid tumor cells. It induces rapid tumor cell death through multiple immune-mediated mechanisms. Additionally, daratumumab has been shown to target immunosuppressive cells within the tumor microenvironment, thereby exhibiting immunomodulatory activity.

In July 2019, daratumumab was conditionally approved by the NMPA for the first time and launched in China. It was indicated as monotherapy for adult patients with relapsed and refractory multiple myeloma who had previously received treatments including proteasome inhibitors (PI) and immunomodulatory agents and experienced disease progression during their last treatment. In April 2021, daratumumab was approved in China for its second indication: in combination with lenalidomide and dexamethasone or in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who had received at least one prior therapy.

4. Tenofovir Alafenamide Fumarate Tablets

Tenofovir Alafenamide Fumarate Tablets, developed by Gilead, target the liver and require only one-tenth the dosage of Tenofovir Disoproxil, thereby reducing the incidence of side effects such as renal impairment and decreased bone density. In 2018, Tenofovir Alafenamide Fumarate Tablets were approved for marketing in China and are used to treat chronic hepatitis B in adults and adolescents (aged 12 years and above, weighing at least 35 kg).

To date, there is no antiviral drug that can completely cure hepatitis B, but antiviral drugs can suppress the replication of the hepatitis B virus, thereby halting the progression of the disease, reversing liver cirrhosis, and reducing the incidence of liver cancer.Tenofovir Alafenamide Fumarate is the only new hepatitis B drug approved by the FDA in nearly 10 years, and is hailed as a "miracle drug" for hepatitis B.

As of now, the generic versions of Tenofovir Alafenamide Fumarate Tablets produced by Chengdu Bright Future Pharmaceutical, Qilu Pharmaceutical, Qingfeng Pharmaceutical, and Hunan Zhengtai Jinhu Pharmaceutical Co., Ltd. have been approved for marketing in China.