ST Bailing Subsidiary's Inhaled BD77 Receives Clinical Trial Approval

Product / Tech
โดย 于单一法定中药材经分离纯化获得的小分子化·CN·Read original
Summary · why it matters

ST Bailing's wholly-owned subsidiary, Bailing Yuxiu Zhuhai Pharmaceutical Co., Ltd., has received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration. The clinical trial application for the innovative drug inhaled BD77 has been approved, allowing clinical trials for chronic obstructive pulmonary disease. Inhaled BD77 is a small-molecule chemical drug derived from a single statutory Chinese herbal medicine through separation and purification, with purity exceeding 98 percent. The Institute of Chinese Materia Medica at the China Academy of Chinese Medical Sciences completed its druggability research over 25 years. Pharmacological studies suggest it may act by activating endogenous inflammatory inhibitory factors and maintaining lung protease-antiprotease homeostasis, while pharmacodynamic studies show treatment-related effects in multiple pneumonia models. The total number of COPD patients in China is nearly 100 million, with about 1 million deaths each year. The company stated that this approval is an important staged research achievement, but the drug still needs to complete clinical trials and pass review and approval before it can be marketed. There is a risk that preclinical results may not translate into clinical benefit in humans, and recent performance will not be affected.

Impact on stocks 1

Others · 1 stocks

Theme Impact 1

Related news

Amgen Fair Value Target Rises to US$388.03 as Analysts Split on Pipeline Risks

Amgen's updated analyst model lifted its fair value price target to US$388.03 from a prior US$371.93, with the revenue growth assumption rising to 3.50% from 2.93%, the net profit margin assumption moving to 25.15% from 24.84%, the future P/E multiple changing to 25.1x from 24.6x, and the discount rate shifting to 7.96% from 7.70%. The revision reflects a split analyst view, with UBS, Argus, TD Cowen, Scotiabank and Oppenheimer raising their Amgen price targets into a US$420 to US$460 range on the strength of a strong product portfolio, Q2 beats and higher guidance. Wells Fargo and Piper Sandler lifted their targets to US$435, citing external survey work and prescription data they believe support higher long term sales potential for cholesterol and cardiovascular products such as Repatha and Lipfendra. On the bearish side, HSBC downgraded Amgen to Hold and cut its target to US$425 from US$445, saying the stock price now more closely matches its assessment of fair value with limited near term upside, while BMO Capital shifted to a neutral Market Perform stance even with a higher US$450 target, citing ongoing loss of exclusivity headwinds and a need for more clarity on the competitive profile and sales potential of MariTide.
Simply Wall St·6hRead more →

Edwards Lifesciences Targets $2 Billion TMTT Business by 2030 as CMS Expands TAVR Access

Edwards Lifesciences outlined a structural heart growth plan that targets more than US$2 billion in transcatheter mitral and tricuspid revenue by 2030, anchored by its PASCAL, EVOQUE, and Sapien M3 technologies. The plan sits alongside updated Medicare coverage that could enable 100 to 200 additional U.S. centers to perform TAVR procedures, reinforcing the company's transcatheter ecosystem. Edwards' broader narrative projects $8.5 billion in revenue and $2.2 billion in earnings by 2029, requiring 9.3% yearly revenue growth and an earnings increase of about $1.2 billion from $979.9 million today. Three fair value estimates from the Simply Wall St Community cluster between US$91.47 and US$100.96 per share, against a $100.96 fair value that implies 14% upside to the current price. The company still faces risks around margins, tariffs, and competitive pressure in international markets.
Simply Wall St·10hRead more →
impact 4

Novartis Shares Plunge 10% as Del-desiran Fails Late-Stage Trial

Novartis shares fell about 10% after the company said its experimental drug del-desiran failed to meet its primary goal in a late-stage trial for myotonic dystrophy type 1, marking its third clinical setback in a week. The earlier failures involved the cardiovascular drug pelacarsen and a pause of eight trials of the cell therapy rap-cel following three patient deaths. The decline erased roughly 24 billion Swiss francs, or about $29.6 billion, in market value and put Novartis on pace for one of its worst trading days in company history. Barclays had estimated peak annual sales of about $3.1 billion for del-desiran and assigned the drug a 60% probability of success after positive mid-stage results, and the failure raises questions about the $12 billion Avidity acquisition that brought the drug into Novartis' pipeline. Management reaffirmed its full-year financial guidance and maintained its target for 5% to 6% compound annual sales growth from 2025 through 2030, while the company reported successful late-stage results for remibrutinib in multiple sclerosis and expects more data later this year.