China Healthcare:Big is better for consistency evaluation

Heart & brain drugs stunned 1st batch of consistency evaluation.

    On 29 Dec 2017, China’s FDA announced the first batch of 17 generic drug namesfor consistency evaluation on their quality and efficacy (仿制药质量和疗效一致性评价). Twelve of them were heart & brain medicines, among ten of which beinganti-hypertension drugs. The other five drugs were antibiotics, anti-psychotic drugs,anti-cancer and anti-viral for hepatitis and HIV. The latter anti-viral medicine fromChengdu Brilliant Pharma (成都倍特药业) was generic version of Tenofovir?(Disoproxil Fumarate) at 300mg, similar to Sinobiopharm’s (1177.HK, NR)Qingzhong.

    Sinobiopharm’s Tuotuo passed consistency evaluation.

    For HK-listed drug-maker, only one medicine was included into the list, namelySinobiopharm’s Tuotuo 托妥? (Rosuvastatin Calcium Tablets 瑞舒伐他汀钙片).

    This medicine, as a generic version of Crestor?, is well known to its cholesterollowering efficacy. Other heart and brain medicines on that list include genericversions of (1) Plavix? (Clopidogrel); (2) Monopril? (Fosinopril sodium); (3) Avapro?(Irbesartan HCl); (4) Zestril? or Prinivil? (Lisinopril); and (5) Cozaar? (Losartanpotassium). The generic version of Gefitinib Tablets (吉非替尼片) (anti-cancer)from a China A-share listed player had also been included into the list. It is worthnoting that, its tender price in 2017 stood at RMB1,680 per box (250mg) fromGuangxi Province, 29% discount to the original medicine (Iressa?) from AstraZeneca of RMB2,358 per box in Hubei and Sichuan Provinces.

    Consistency evaluation raises China drug-making standard.

    As cited by CFDA newsletter, consistent with government policy to provide qualitymedicine to Chinese masses, we see consistency evaluation will (1) improve themedicine production level from Chinese drug-makers, (2) guarantee drug safetyand effectiveness, (3) promote the sector’s technology upgrades; and (4) raisetheir global competitiveness. We expect more preferential selection of thoseChinese drug-makers whose medicines had passed the consistency evaluationduring central procurement from hospitals.

    Big is better for consistency evaluation.

    Note that, if there are more than three producers of the similar drug type (or drugstructure) getting qualified in consistency evaluation, those drug type or structurefailing to pass consistency evaluation shall not be selected in centralizedprocurement for hospitals. Moreover, we reckon that those medicines from biggerand reputed Chinese drug-makers would likely fulfill the consistency evaluationtests. Those HK-listed Chinese drug-makers with large capacities to produce qualitygeneric drugs include (1) Sinobiopharm; (2) CSPC (1093.HK, NR) and (3) FosunPharm (2196.HK, NR).