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First Generic Just Approved, Third Filing for Market Authorization!

On May 13, the CDE website showed that the third generic version of abemaciclib tablets had submitted a market authorization application, from Shandong Bionuo. Previously, Qilu Pharmaceutical and Jiangxi Kerui Pharmaceutical (a subsidiary of Qingfeng Pharmaceutical) had submitted market authorization applications for abemaciclib tablets in December 2024 and January 2025, respectively. Among them, Kerui Pharmaceutical’s abemaciclib tablets received approval on May 6, becoming the first domestic generic. Abemaciclib is a CDK4/6 inhibitor developed by Eli Lilly. It induces senescence and apoptosis of breast cancer cells by inhibiting cyclin D. The abemaciclib tablet was first approved in the United States in September 2017 and was approved in China in December 2020. According to Lilly’s 2025 annual report, global sales of abemaciclib reached $5.723 billion. In China, data from Mosheng Pharma shows that abemaciclib’s sales in the domestic all-terminal hospital market exceeded RMB 800 million in 2025. Behind this stable market growth ...
- Source: drugdu
- 49
- May 15, 2026
A $15.2 billion deal, the top player blows the show!

At a time when the industry is repeatedly plagued by anxiety about going global, Hengrui has made a stunning move with a deal worth tens of billions of US dollars! On May 12, Hengrui Medicine and Bristol-Myers Squibb (BMS) announced that they have entered into a global strategic collaboration and licensing agreement to jointly advance 13 early-stage projects covering oncology, hematology and immunology, with a potential total transaction value of approximately US$15.2 billion. The significance of this collaboration goes far beyond the monetary amount; the true core of this “deep-water bomb” lies in the dual innovations in the cooperation model and payment structure. This agreement is not the typical one-off deal for a single pipeline in the industry, but rather it directly extends and broadens the scope of cooperation—Hengrui has the option to jointly develop specific projects and has the opportunity to jointly carry out specific commercialization activities with BMS ...
- Source: drugdu
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- May 15, 2026
//news.yaozh.com/archive/48019.html Abesilli tablets

Abesilli tablets: The first imitation breakthrough on the CDK4/6 track. Abeciclib, an original CDK4/6 inhibitor developed by Eli Lilly, was approved by the FDA in 2017 and entered the Chinese market at the end of 2020. From a global perspective, abeciclib’s rise is a textbook example of a latecomer surpassing its predecessor. Pfizer’s palbociclib, as the first CDK4/6 inhibitor, long dominated the market in this field, but abeciclib, with its unique clinical advantages—a continuous dosing regimen (unlike other CDK4/6 inhibitors that require intermittent dosing) and the only approved indication in China for adjuvant therapy in early breast cancer—successfully wrested the baton from palbociclib. Abeciclib’s global sales surged from 8.8 billion yuan in 2021 to 17.3 billion yuan in 2023, and further exceeded 37.7 billion yuan in 2024, officially becoming the world’s best-selling CDK4/6 inhibitor. Returning to the Chinese market, abexicillin’s sales have also surged rapidly. Data shows that domestic sales ...
- Source: drugdu
- 36
- May 15, 2026
Gilead’s new HIV drug “exceeds expectations”

Gilead Sciences recently released its first-quarter financial results: total revenue increased by 4% year-over-year to $7 billion. Sales of its HIV product portfolio reached $5 billion, a 10% year-over-year increase. Among them, the long-acting PrEP injection Yeztugo (lenapavir), administered every six months, was the biggest highlight. Its quarterly revenue reached $166 million, a nearly 73% increase quarter-over-quarter, far exceeding market expectations. Gilead’s Chief Commercial Officer, Johanna Mercier, described the long-acting injection’s opening performance as an “unprecedented launch trajectory” and significantly raised its first full-year sales forecast from $800 million to $1 billion. Mercier further pointed out that the drug will see “steady and continuous sales growth” in the coming years, and the company is committed to expanding its use to all people who need HIV prevention. 01 Yeztugo sales “exceeded expectations” Yeztugo’s active ingredient, lenacapavir, is a first-in-class HIV capsid inhibitor. Its mechanism of action differs from traditional nucleoside reverse ...
- Source: drugdu
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- May 15, 2026
Lispro insulin receives EU approval, marking the first time domestically produced insulin has broken the European monopoly on original drugs.

From breaking into the market with a single product to expanding overseas with a matrix of products, Gan & Lee Pharmaceuticals has obtained EU approval for three insulin analogues in less than six months. This is not only an authoritative recognition of the company’s product quality and manufacturing process, but also signifies that insulin produced in China has reached a level comparable to original drugs. Gan & Lee Pharmaceuticals has become the first Chinese pharmaceutical company to obtain approval for three third-generation insulin products in the EU, breaking the long-standing monopoly of the European market by original drug giants. Beijing, China, May 14, 2026 – Gan & Lee Pharmaceuticals Inc. (hereinafter referred to as Gan & Lee Pharmaceuticals, stock code: 603087.SH) announced that its product, insulin lispro injection (EU trade name: Bysumlog® , China trade name: Suxiulin®1 ) , has officially received marketing approval from the European Commission (EC). This ...
- Source: drugdu
- 34
- May 15, 2026
Jinsai Pharmaceutical’s Fuxinqi Alimamab receives clinical approval for a new indication, focusing on the prevention of acute gout attacks in the early stages of uric acid-lowering therapy.

Recently, the clinical trial application for voricipamab injection (aqueous formulation), independently developed by Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as “Jinsai Pharmaceutical”), for “reducing the risk of acute attacks in gout patients in the initial stage of uric acid-lowering therapy” has been officially approved. This means that voricipamab is expected to provide a novel intervention for preventing acute attacks in gout patients at the critical stage of initiating uric acid-lowering therapy. If the clinical trial is successful, it may fill the gap in precision anti-inflammatory treatment for gout in my country. According to statistics, there are more than 177 million people with hyperuricemia and more than 30 million people with gout in China, and the incidence rate is trending younger [1] . Gout is a common inflammatory joint disease caused by the deposition of monosodium urate (MSU) crystals. Repeated gout attacks may lead to joint damage and multi-system ...
- Source: drugdu
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- May 15, 2026
Zhong Sheng Pharmaceutical’s innovative pediatric influenza drug application for market launch

Recently, ZS Pharmaceutical announced that the new drug application for Angravir granules, an innovative Class I drug developed by its subsidiary Guangdong ZS Ruicheng Biotechnology Co., Ltd. for the treatment of uncomplicated influenza A in children aged 2 to 11 years, has been formally accepted by the National Medical Products Administration (NMPA). Onradivir is a small RNA polymerase PB2 protein inhibitor. It can bind to the PB2 subunit by acting as a “cap” structure analog, thereby inhibiting the normal initiation of the RNA polymerase complex replication function. This inhibits multiple functions of the viral life cycle genome, such as transcription and replication, thus achieving an anti-influenza A virus effect. On May 20, 2025, ondiravir tablets were approved by the National Medical Products Administration for the treatment of adult patients with uncomplicated influenza A. Ondiravir is the world’s first innovative drug targeting the PB2 subunit of influenza A virus RNA polymerase, ...
- Source: drugdu
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- May 15, 2026
【EXPERT Q&A】What are the characteristics of medical device clinical trials compared to drug clinical trials? What are the differences between the two?

Drugdu.com expert’s response: Characteristics of Medical Device Clinical Trials 1. Extreme Product Diversity Active devices, passive implants, in vitro diagnostic (IVD) reagents, software, imaging equipment… each category requires nearly completely different trial protocols, endpoint definitions, and operational procedures. 2. Results Are Highly Operator-Dependent This is the most prominent feature of device trials. Especially for surgical and implantable devices: the same product operated by different surgeons can yield drastically different outcomes. Therefore, the technical proficiency, training, and consistency of investigators are critical. You could say the trial results are co-determined by “the doctor + the device.” 3. More Flexible but Often Simpler Designs Common designs include parallel, paired, crossover, and single-arm. But many devices lack suitable controls, cannot be blinded (surgical devices/large equipment are very hard to blind), or are ethically unsuitable for randomization — so a large proportion are single-arm/single-group trials. Protocols are typically much “thinner” than drug trials. 4. ...
- Source: drugdu
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- May 15, 2026
Juventas Biotech’s third new drug application! The new drug application for YuanRuida, used to treat childhood acute lymphoblastic leukemia, has been accepted

On May 11 , 2026 , Juventas Biotechnology Co., Ltd. (hereinafter referred to as ” Juventas Biotechnology ” ) announced that the National Medical Products Administration ( NMPA ) has formally accepted its New Drug Application ( NDA ) for its core product , YuanRuida® (Nakiolensai Injection) , for the treatment of relapsed or refractory B- cell acute lymphoblastic leukemia ( r/r B-ALL ) in children. This is the third New Drug Application submitted by Juventas Biotechnology, a Chinese-developed CD19 CAR-T product , following the NMPA approvals for its two other New Drug Applications for the treatment of relapsed or refractory B- cell acute lymphoblastic leukemia in adults and relapsed or refractory large B- cell lymphoma in adults . This marks another significant milestone for Juventas Biotechnology in the research and development of innovative CAR-T cell drugs. YuanRuida® becomes the only CAR-T product capable of simultaneously covering adult acute lymphoblastic ...
- Source: drugdu
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- May 14, 2026
Xinhua Pharmaceutical obtains drug registration certificate for ambroxol oral solution, a cough and asthma reliever.

Recently, Xinhua Pharmaceutical’s Ambroxol Oral Solution was approved by the National Medical Products Administration and obtained the “Drug Registration Certificate”. Ambroxol hydrochloride oral solution is a compound preparation composed of ambroxol hydrochloride and clenbuterol hydrochloride, with a specification of 100ml: 150mg of ambroxol hydrochloride and 100μg of clenbuterol hydrochloride. Ambroxol hydrochloride is a mucolytic agent that increases the secretion of serous glands in the respiratory mucosa, reduces mucus secretion, lowers sputum viscosity, promotes the secretion of pulmonary surfactant, and increases bronchial ciliary movement, making sputum easier to cough up. Clenbuterol hydrochloride is a selective β-receptor agonist that relaxes bronchial smooth muscle, enhances ciliary movement, dissolves mucus, and promotes sputum expectoration. Ambroxol hydrochloride oral solution is used to treat cough, thick sputum, difficulty in expectoration, and wheezing caused by acute and chronic respiratory diseases (such as acute and chronic bronchitis, emphysema, etc.), and has a triple effect of relieving cough, expectoration, ...
- Source: drugdu
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- May 14, 2026

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