Today, China’s biopharmaceutical industry is awaking and rapidly emerging as a valuable contributor to the global healthcare industry, not only with its accelerating innovation activities but also with its quality standards and regulatory compliances that meet local NMPA and FDA and EU requirements.
The Chinese biopharmaceutical domain, providing participating members with a global platform for innovation, is propelled by China’s regulatory reforms, the establishment of bio clusters, talent returning from overseas, and the widening funding from the country’s capital market. Amongst the accomplished firms, Sinotherapeutics Inc. (SinoT) is regarded as the archetype of China’s biopharmaceutical industry. The company rises above its peers and competitors by offering drug formulation and analytical development services that render its clients to attain fast-track drug development results in a cost-effective manner while ensuring the highest levels of quality and regulatory compliances adhering to international standards.
Under the able stewardship of Dr Jason Wan, founder and CEO of SinoT, the company has grown substantially and attained great successful track records over the last ten years, and consolidated its position in APAC’s market as a leader in formulation/analytical CRO/CMO businesses. Having worked with industry giants such as Pfizer, Merck, Roche, Schering-Plough, and Wuxi AppTec, Dr Wan and the company’s CTO, Dr Larry Fang, who has similar longstanding experiences in the biopharmaceutical industry, have supported the formulation and analytical development for over a hundred molecules in early development stages and in clinical sample manufacturing.
SinoT’s R&D center and manufacturing facility, Haimen Pharma (wholly-owned), are located in the ‘Drug Valley’ of Shanghai, and Jiang Xu province (two hours away from Shanghai), respectively, and they have a combined 250 highly-skilled staff and advanced formulation equipment trains and analytical instruments. Both locations have passed NMPA, FDA, and clients’ on-site audits many times. SinoThas well-established tech platforms – hot-melt extrusion (HME) & Spray Dryer/Fluid-bed, organic solvent coating, all kinds of conventional and specialty sustained drug release dosage forms, Xcelodose for powder-in-capsules et al., and thus position it well to meet conventional and or specialty dosage from requirements of its clients, whether it is for an exploratory study, or for cGMP manufacture for clinical supplies, and or for commercial production.
“We have extensive experiences in dealing with all sorts of development issues facing early drug discovery. Ergo, we are highly proficient in assisting our clients in attaining fast-cycle product department results, pertaining especially to difficult molecules, while ensuring international quality & regulatory compliances and cost-effectiveness,” says Dr Wan.
On multiple occasions, SinoT has demonstrated its proficiency not only in carrying out conventional but also in challenging formulation developments successfully, such as enhancing solubility and in-vivo exposure for poorly soluble NCE compounds and preparing clinical samples for phase I-III clinical trials and regulatory dossier for filing – all with international quality standards and regulatory compliances, and at unmatched speed.
For any given project, SinoT will have a designated project leader and team, who will conduct a comprehensive discussion with the client, identifying the impetus for all possible developmental issues, and then provide recommendations to get concurrence from clients, and carry out follow-on development activities till the completion of the projects, with many pre-arranged in between discussions with clients.
Leveraging SinoT’s team of experts and unique infrastructure setup, SinoT has attained a great track record for developing value-added formulations with successes, such as enhancing solubility of otherwise poorly soluble compounds and thus achieving much enhanced in vivo exposure results for many compounds for its clients. The company is very proficient in making solubility-enhancing formulations, such as micro-/nano- particles, micro-emulations, and solid dispersions using HME processes or spray dry processes. In regard to HME, SinoT has equipment trains covering 12mm, 18mm, and 27mm holt-melt extruders, fulfilling any requirements of its customers.
We deliver value-added work/solution in a timely and cost-effective manner and meet the quality and regulatory requirements for global markets, including FDA, EU, and NMPA (China)
A case study wherein the company assisted its client in improving the solubility and in vivo exposure of their compounds stands testimony to the company’s capabilities.
The client had developed an immediate release dosage that suffered poor solubility and did not reach the desired dose-escalation outcome required for phase-I clinical trials. After taking orders from the client for reformulation support, SinoT produced solid dispersion for the compound, and the reformulated product resulted in a 10X increase in in-vivo exposure. The significantly enhanced in vivo exposure allows much-reduced dose requirement for the compound – from the originally anticipated 100mg to 5mg – saving hugely on API consumption and associated costs. Deploying similar technical capabilities and capacities, SinoT has successfully delivered tens of IND, 5 NDA, and 6 ANDA registration batches for its customers.
Due to its customer-centric approaches and its strong and attenable technical and manufacturing capabilities and capacities, Sinotherapeutics Inc. is highly differentiated from its peers and on route to leading the wave of innovation in China’s biopharmaceutical industry.