This week, the biopharmaceutical field saw several major advances: the Shengbai ® Gudao hearing aid was approved domestically; Wuwei Disinfection Drink Granules and Banxia Baizhu Gastrodia Decoction Granules were approved on the same day; Otsuka Pharmaceutical’s new ADHD drug SIMTRIYO® has been approved by the FDA, breaking a nearly 30-year gap in mechanisms. Additionally, Insilico Technologies ISM6331 and Huode Biotech’s hNPC01 both qualified for FDA fast track status; Hengrui SHR-4375 was designated as an orphan drug by the FDA; Jianda Biotech’s recombinant influenza vaccine JD02 has received FDA clinical approval. Welcome to learn more~

1. Shengbo ® Glasses Bone Guide Hearing Aid Approved for Domestic Launch

Recently, the Shengbo ® Glasses bone conduction hearing aid, independently developed by Shengtuo Medical Technology (Shanghai) Co., Ltd., was officially approved for Class II medical device registration by the National Medical Products Administration. It has brought a brand-new non-invasive solution to over 30 million domestic patients with unilateral hearing loss and conductive hearing loss, filling the gap in the domestic bone conduction hearing aid market that balances medical efficacy, non-invasive wearability, and visual concealment. According to data from the China Hearing Health Report, there has long been a significant supply-demand mismatch in adaptation schemes for unilateral and conductive hearing loss groups in China: implantable bone conduction devices require cranial surgical trauma and pose a risk of postoperative infection; Ordinary consumer-grade bone guide hearing earphones have not obtained Class II medical device certification, and their acoustic parameters do not meet clinical hearing compensation requirements, making them unsuitable for disease intervention; Traditional external bone conduction hearing aids have a highly recognizable appearance, which easily causes a sense of stigma among wearers and is very low public acceptance. The approved Shengbo ® strictly adheres to ISO international hearing device standards and domestic clinical validation requirements, adopts Europe’s high-end bone conduction vibration core technology, achieves medical-grade acoustic performance, with a maximum gain of 49dB and a full-charge battery life of up to 20 hours, with acoustic parameters fully meeting clinical hearing compensation standards. The product is launched in three major series: children’s, fashion, and business. Its appearance is identical to ordinary optical glasses, eliminating the psychological burden of wearing from a design perspective. It also supports flexible switching between single-sided and dual-sided wear, solving the common pain points of traditional bone conduction devices such as strong pressure when wearing and limited adaptability to different scenarios.

2. Two new traditional Chinese medicine drugs approved on the same day!

On July 23, the latest drug marketing authorization announcement from the National Medical Products Administration (NMPA) showed that Ruiyang Pharmaceutical’s classic formula preparation “Wuwei Xunxianyin Granules” and Sichuan Everbright Pharmaceutical’s “Banxia Baizhu Gastrodia Decoction Granules” were both approved for market launch. Among them, Wuwei Jinjian Drink originates from the authoritative Qing Dynasty medical text ‘Yizong Jinjian’ and is a core formula for clearing heat and detoxifying that has been used clinically for centuries. Ruiyang Pharmaceutical is the first company in China to be approved for this variety. Coupled with the recent launch of multiple proprietary Chinese medicines and the pipeline layout of more than ten new Chinese medicine drugs under development, this marks its official deep entry into the blue ocean market of classic Chinese medicine formulas exceeding 400 billion yuan. Another variety, Banxia Baizhu Tianma Decoction, originates from the Qing Dynasty’s “Medical Insights” and is mainly used to treat common conditions such as dizziness and headache caused by wind-phlegm disturbance syndrome. It has a broad clinical audience. Sichuan Everbright Pharmaceutical is the second domestic approved entity for this variety. According to the public review progress, Yiling Pharmaceutical’s product is still in the market application review stage, and the qualification process in the next track will become clearer. As of the approval of these two products, by 2026, a total of 19 classic Chinese medicine new drugs have been approved domestically, far surpassing the total implementation speed of the previous two years, continuously unleashing innovation momentum in traditional Chinese medicine.

3. Insilico Intelligence’s AI-driven pan-TEAD inhibitor ISM6331 received FDA Fast Track designation

Recently, Insilico Intelligent (03696.HK), a leading AI innovative drug listed on the Hong Kong Stock Exchange, announced that its potential best-in-class pan-TEAD inhibitor ISM6331, developed through AI-driven full chain, has officially received Fast Track Designation (FTD) from the U.S. FDA. Its indications cover adult patients with late-stage dermatoma who have progressed after anti-PD-1 antibody monotherapy or combination anti-CTLA-4 antibody immunotherapy. As one of the most urgent sectors for unmet medical needs in solid tumors, the overall 5-year survival rate for late-stage dermatoma is less than 10%. After advances in first-line immunotherapy and chemotherapy, there is still no approved standard treatment worldwide, and a large number of drug-resistant patients have no available medication. ISM6331 targeting the Hippo pathway, the TEAD family of core effector proteins is a core pipeline Pharma.AI Insilico Intelligence, leveraging its own end-to-end AI drug development platform, accelerating the entire process from target validation and molecular generation to druggability optimization. Preclinical data show that it maintains nanomolar high inhibitory activity against all four TEAD subtypes, with off-target toxicity control and tissue distribution performance significantly superior to global competitors in the same track, demonstrating a distinct differentiation advantage. After securing FDA Express Track qualification, ISM6331 will receive a series of accelerated regulatory supports: R&D teams can engage in high-frequency synchronized communication with FDA review departments, initiating rolling reviews without waiting for all documents to be completed. If subsequent Phase II clinical trials obtain statistically significant objective response rate endpoints, they can directly apply for priority review or even accelerated approval. The overall market launch process is expected to shorten by 1-2 years compared to conventional pathways, making it a landmark regulatory recognition node in the global AI-driven pharmaceutical pipeline for targeted solid tumors , opening up an efficient review pathway for subsequent clinical development of innovative drugs via the Hippo pathway.

4. Huode Biotech’s iPSC neuronal cell therapy dual-indication has been recognized in the FDA Fast Track

On July 29, Huode Biotech, a leading domestic original iPSC cell therapy company, announced that its self-developed human iPSC-derived neural precursor cell product hNPC01 has added two new indications—for hemorrhagic stroke and post-cranial brain injury motor dysfunction, which has been officially recognized under the U.S. FDA Fast Track designation. It offers accelerated regulatory benefits such as rolling Biologics License Application (BLA), priority review, and full-process guidance from the FDA’s dedicated clinical team, significantly shortening the product development and market launch cycles. Post-central nervous system injury and motor dysfunction remains a major clinical challenge worldwide. Current clinical interventions can only achieve limited functional compensation through rehabilitation training, and there are no causal-targeted therapies for repairing damaged neural circuits. Currently, China experiences over 1 million new hemorrhagic stroke cases annually, over 2 million new cases of cranial brain injury annually, and over 10 million existing sequel patients, resulting in a significant gap in clinical demand. As a global First-in-Class iPSC-derived neuronal product, hNPC01 can differentiate into mature functional neurons at the injury site after transplantation, reconstructing local neural connections and achieving fundamental restoration of motor function. Previously, this product had already obtained FDA Fast Track qualification for its ischemic stroke pipeline, and the two new indications have simultaneously received FDA IND approval. Currently, Huode Biotech has completed a global clinical layout for hNPC01 for three major central nervous system injury indications, becoming the world’s first cell therapy company to achieve multi-pipeline synchronized compliant advancement in this field. It is expected to be the first to fill the gap in central nervous system injury treatment and provide a new cure pathway for the vast number of patients worldwide with untreatable central nervous system injuries.

5. Jianda Bio’s new generation recombinant influenza vaccine received FDA clinical approval

Recently, Chinese innovative vaccine company Jianda Bio announced that its independently developed new generation recombinant protein trivalent influenza vaccine JD02 has officially received FDA clinical trial approval in the United States, becoming the first domestic pharmaceutical company to obtain U.S. clinical access in the field of recombinant protein influenza vaccines. This IND application process involved no major corrections and passed FDA review in one go, fully validating that its R&D system fully meets the highest global regulatory standards. For a long time, mainstream chicken embryo-cultured influenza vaccines have faced industry pain points such as lagging annual strain matching, frequent antigenic adaptive mutations during cultivation, and production cycles of 6-9 weeks. The global influenza vaccine industry is accelerating its iteration toward new-generation technological pathways such as recombinant proteins. JD02 uses the Sf9 insect cell expression system to produce recombinant hemagglutinin antigen, combined with a self-developed novel adjuvant system. Through antigen-conserved epitope targeted optimization, it greatly enhances immune response levels, more than doubling production efficiency compared to traditional processes, significantly enhances the ability to update and respond to annual circulating strains, and improves immune protection efficacy across all age groups, especially high-risk elderly populations.

According to disclosures, Jianda Biotech has completed nearly 100 million yuan in Pre-A round financing and is building a diversified product pipeline covering preventive and therapeutic vaccines. Subsequently, it will advance synchronized overseas clinical development of JD02 and accelerate commercialization through industry cooperation. Currently, the global recombinant protein influenza vaccine sector is still in development. Domestic R&D of similar products is accelerating but has yet to achieve mature commercialization. The approval for JD02’s overseas clinical trials marks that domestic innovative vaccine companies now possess the core strength to compete internationally in the next-generation influenza technology sector.

6. Prolo Pharmaceuticals: Levocarnitine oral solution obtained drug registration certificate

On July 28, ProPharma (000739. SZ) has issued an official announcement stating that its controlling subsidiary, Zhejiang Procangyu Pharmaceutical Co., Ltd., has officially received the “Drug Registration Certificate” for levocarnitine oral solution issued by the National Medical Products Administration. This marks the successful completion of the full R&D review process for this clinically essential metabolic product and the imminent start of commercialization, further enriching the company’s pipeline matrix in the fields of nephrology and rare disease metabolism. As the naturally occurring active form of L-carnitine in the human body, levocarnitine is the core carrier for transmembrane oxidative energy supply of fatty acids. The approved oral solution not only precisely covers approved indications: primary systemic carnitine deficiency and short-term and long-term full-cycle treatment of secondary carnitine deficiency caused by congenital metabolic abnormalities, but is also widely used clinically for endogenous carnitine supplementation interventions in chronic renal failure patients with long-term hemodialysis, adjunctive therapy for male infertility, and symptomatic support for children with hereditary metabolic defects , a highly clinically recognized niche and essential necessity. According to industry database statistics, there are currently fewer than 10 licensed companies for Lvocarnitine oral solution in China, and original products have long occupied over 60% of the high-end medical institution market, leaving significant room for improvement in patient medication accessibility. This time, Prolo Pharmaceutical’s product was developed entirely according to consistency evaluation standards. Once approved, it is considered as passing the consistency evaluation and directly obtaining the qualification to participate in national volume-based procurement. Relying on the company’s API formulation full industry chain cost advantages and nationwide commercialization network, after listing, it will rapidly expand to medical institutions at all levels, significantly reducing the long-term medication burden for rare metabolic diseases and hemodialysis patients, and bringing a new incremental performance curve to the company’s formulation segment.

7. World’s first new drug for “ADHD” approved for market

On July 24, Japan’s Otsuka Pharmaceutical announced that its globally pioneering neuropsychiatric drug SIMTRIYO® (generic name centanafadine) has been officially approved by the U.S. FDA. It is used to treat attention deficit hyperactivity disorder (ADHD) in adults and children aged 6 and above, weighing no less than 20 kg. It is the first newly approved first-in-class drug in the field of ADHD treatment in the past decade. Currently, there are over 70 million ADHD patients globally. Current clinical protocols mainly focus on stimulant drugs and mono- or bilateral-targeted non-stimulant drugs, but nearly 30% of patients still have insufficient response, poor tolerance, and unmet clinical needs due to insufficient comorbidities. SIMTRIYO is currently the world’s first and only approved triple reuptake inhibitor (NDSRI) containing norepinephrine, dopamine, and serotonin. By simultaneously enhancing the extracellular availability of three key neurotransmitters in the prefrontal cortex, it precisely matches the core pathological mechanism of ADHD multitransmitter regulatory imbalance, filling the previous gap where ADHD treatments only covered types 1-2 of neurotransmitters. This approval is based on four key Phase III clinical trial data covering all age groups: both adult and child/adolescent cohorts achieved primary efficacy endpoints, total ADHD symptom rating scores showed significantly better improvement than baseline compared to placebo, statistically significant symptom relief was observed in the earliest first week of dosing, overall tolerability was excellent, and no signs of serious cardiovascular adverse events that were previously alerted to ADHD drug warnings were observed. Currently, Otsuka Pharmaceutical is also advancing follow-up clinical development of SIMTRIYO for anxiety disorders and binge eating disorder in ADHD high comorbidity scenarios, further expanding the clinical value boundaries of this First-in-Class product.

8. Hengrui Medicine’s SHR-4375 injection for pancreatic cancer received orphan drug designation from the U.S. FDA

On July 28, according to the latest official announcement from Hengrui Medicine, its self-developed antibody-drug conjugate (ADC) SHR-4375 injection, which targets tissue factor (TF), for pancreatic cancer indication, has officially received orphan drug designation from the U.S. FDA, marking an acceleration of the global commercialization process of its pioneering domestic precision therapy pipeline. As the clinically recognized “king of cancers,” the global five-year overall survival rate for pancreatic cancer is less than 12%, with over 90% of patients diagnosed at advanced stages. The response rates to existing chemotherapy, targeted, and immunotherapy regimens are extremely low, and there is a significant gap in clinical demand. Clinical validation shows that over 90% of pancreatic cancer cells have high expression of tissue factor targets on their surface, making it a highly promising emerging target for ADC drug development. Currently, SHR-4375 is in the leading development tier in the global ADC pipeline for similar targets. According to publicly disclosed progress, the domestic clinical trial of SHR-4375 has advanced to Phase II, with enrollment for patients with core indications for advanced pancreatic cancer progressing in an orderly manner, with cumulative R&D investment reaching approximately 58.7 million yuan. After obtaining FDA orphan drug designation, products can enjoy up to 50% of clinical trial fee tax credits, full exemption from new drug marketing application fees, exclusive rights to the U.S. market for seven years after approval, and other special policy support. At the same time, they receive comprehensive guidance from the FDA for clinical development, significantly reducing R&D risks and costs. Industry analysts point out that this recognition will significantly accelerate the dual submission process between China and the US for SHR-4375, potentially filling the gap in precision treatment for advanced pancreatic cancer, and marking another important breakthrough for Hengrui’s self-developed ADC pipeline entering the global market.

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