Qilu Pharmaceutical Leads with 13 Approved Consistency Evaluation Filings in H1 2019 Amid Industry Surge

In 2019, the work on consistency evaluation achieved remarkable success. According to data from Menet, in 2018, there were 124 product approval documents that passed the consistency evaluation, involving 62 products; in the first half of 2019 (as of June 30), the number of product approval documents that passed the consistency evaluation reached 163, involving 87 products. Overall, the achievements of the first half of 2019 had already surpassed those of the entire year of 2018, which is no easy feat.

163 Approval Documents Passed Evaluation in the First Half of 2019, with Outstanding Performance in Three Major Categories

Table 1: Latest Status of Products That Have Passed the Consistency Evaluation

(Source: MENET MED China Drug Review Database 2.0)

Figure 1: Distribution by Category of Approved Drug Approvals in the First Half of 2019

According to statistics from Menet, among the 163 approval documents that passed the consistency evaluation in the first half of 2019, systemic anti-infective agents accounted for 48, cardiovascular system drugs for 30, and digestive system and metabolic drugs for 29.

In 2018, the total market size of chemical drugs at the terminal level of China’s public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—approached RMB 1.0325 trillion. Therapeutic categories with market sizes exceeding RMB 100 billion included systemic anti-infectives, digestive system and metabolic drugs, blood and hematopoietic system drugs, antineoplastic and immunomodulating agents, cardiovascular system drugs, and nervous system drugs. This indicates that, in the current consistency evaluation work, most pharmaceutical companies are focusing heavily on large markets and major products.

Systemic Anti-infective Agents: 48 approvals, 22 products

Table 2: Systemic Anti-infective Drugs That Passed the Evaluation in the First Half of 2019

(Source: Menet MED China Drug Review Database 2.0)

Among the 22 products that have passed the consistency evaluation, only 11 products—namely Pyrazinamide Tablets, Fluconazole Capsules, Lamivudine Tablets, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Rifampicin Capsules, Oseltamivir Phosphate Capsules, Tinidazole Tablets, Cefdinir Capsules, Cefixime Capsules, Cefadroxil Tablets, and Levofloxacin Tablets—have so far been approved for only one manufacturer each.

In 2018, at the terminal of public medical institutions in China, among the aforementioned 11 products that passed the consistency evaluation by a single manufacturer, Cefdinir Capsules and Cefixime Capsules achieved sales exceeding RMB 1 billion. Products with sales exceeding RMB 100 million included Fluconazole Capsules, Lamivudine Tablets, Rifampin Capsules, Oseltamivir Phosphate Capsules, Cefadroxil Tablets, and Levofloxacin Tablets.

Lamivudine and Tenofovir Disoproxil Tablets are classified as Class 3 generic drugs for registration purposes. Currently, Anhui Biocause Pharmaceutical Co., Ltd. is the only manufacturer approved for production in the domestic market, which is deemed to have passed the consistency evaluation.

Cardiovascular Drugs: 30 Approvals, 15 Products

Table 3: Cardiovascular System Drugs That Passed the Consistency Evaluation in the First Half of 2019

(Source: MENET MED China Drug Review Database 2.0)

Rosuvastatin Calcium Tablets, manufactured by Lek Pharmaceuticals d.d., a subsidiary of Sandoz under Novartis, became the first generic drug from a foreign pharmaceutical company to pass the consistency evaluation, sparking heated discussion in the industry.

Among the 15 products that have passed the consistency evaluation, only one manufacturer has obtained approval for each of the following: Isosorbide Mononitrate Tablets, Candesartan Cilexetil Tablets, Pitavastatin Calcium Tablets, Hydrochlorothiazide Tablets, Simvastatin Tablets, Benazepril Hydrochloride Tablets, Propranolol Hydrochloride Tablets, and Trimetazidine Hydrochloride Tablets.

In 2018, at the terminal of public medical institutions in China, among the aforementioned products with only one passing the evaluation, those with sales exceeding RMB 1 billion included Simvastatin Tablets, Benazepril Hydrochloride Tablets, and Trimetazidine Hydrochloride Tablets; those with sales exceeding RMB 100 million included Isosorbide Mononitrate Tablets and Candesartan Cilexetil Tablets.

Digestive System and Metabolic Drugs: 29 Approvals, 15 Products

Table 4: Digestive System and Metabolic Drugs That Passed Evaluation in the First Half of 2019

(Source: MENET MED China Drug Evaluation Database 2.0)

Among the 15 products that have passed the consistency evaluation, only one company has passed for each of the following: Acarbose Capsules, Acarbose Tablets, Hydrotalcite Chewable Tablets, Saxagliptin Tablets, Vildagliptin Tablets, Vitamin B2 Tablets, Ondansetron Hydrochloride Tablets, and Ranitidine Hydrochloride Capsules.

In 2018, at the terminal of public medical institutions in China, among the aforementioned products with only one passing the consistency evaluation, Acarbose Tablets had sales exceeding RMB 1 billion, while Acarbose Capsules and Ondansetron Hydrochloride Tablets each had sales exceeding RMB 100 million.

Strongest Strength! Top 8 Companies with Approved Evaluations Exposed

In the first half of 2019, 163 approval documents passed the consistency evaluation, covering 87 products. Data statistics from Menet show that there were 8 pharmaceutical companies (including subsidiaries) with more than 5 approved documents. Qilu Pharmaceutical, Fosun Pharmaceutical, and Kelun remain in the first tier, while Humanwell, China Resources, Salubris, and HEC CJ PHARM are accelerating their catch-up efforts.

Table 5: Pharmaceutical Companies (Including Subsidiaries) with More Than Five Approved Evaluations in the First Half of 2019

(Source: MENET MED China Drug Review Database 2.0)

Qilu PharmaceuticalIn the first half of 2019, the number of approval documents passing the consistency evaluation reached 13, involving nine major products. Among them, olanzapine orally disintegrating tablets, lenalidomide capsules, and ondansetron hydrochloride tablets currently have only one manufacturer each that has passed the evaluation.

Fosun PharmaceuticalIn the first half of 2019, the number of approval documents passing the evaluation reached 12, involving seven major products. Among them, only one enterprise has passed the evaluation for Pyrazinamide Tablets, Quetiapine Fumarate Tablets, and Rifampicin Capsules.

KelunIn the first half of 2019, the number of approval documents that passed the evaluation reached 11, involving seven major products. Among them, Metronidazole Tablets, Citalopram Hydrobromide Capsules, and Tinidazole Tablets currently have only one enterprise each that has passed the evaluation.

In the first half of 2019, the number of approval documents for generic drug consistency evaluation reached five each for the second-tier companies: Chia Tai Tianqing, Humanwell Healthcare, China Resources Pharmaceutical, Salubris, and HEC CJ PHARM.

Humanwell HealthcareAll five products passed the consistency evaluation in the first half of 2019, and currently only one enterprise has passed the evaluation for Vitamin B2 Tablets.

China Resources PharmaceuticalIn 2018, there was one approved document that passed the evaluation, namely Amlodipine Besylate Tablets. In the first half of 2019, five approved documents passed the evaluation, involving four products. As of now, China Resources Pharmaceutical has six approved documents that have passed the evaluation, covering five products. Among them, only one company has passed the evaluation for Aluminum Magnesium Carbonate Chewable Tablets, Mifepristone Tablets, and Terazosin Hydrochloride Tablets.

SalubrisAs of 2018, there were four approved documents, including Clopidogrel Bisulfate Tablets (two approvals) and Ticagrelor Tablets (two approvals). In the first half of 2019, the number of approved documents reached five, involving four products. To date, Salubris has obtained nine approved documents for six products, among which Desloratadine Tablets, Pitavastatin Calcium Tablets, Benazepril Hydrochloride Tablets, and Levetiracetam Extended-Release Tablets have only one company approved.

HECDrugIn 2018, four marketing approvals were granted following consistency evaluation, including one for Clarithromycin Sustained-Release Tablets, two for Clarithromycin Tablets, and one for Moxifloxacin Hydrochloride Tablets. In the first half of 2019, five marketing approvals were granted, covering three products. To date, HEC CJ PHARM has obtained nine marketing approvals through consistency evaluation, involving six products. Among these, only one enterprise has passed the consistency evaluation for Clarithromycin Sustained-Release Tablets, Clarithromycin Tablets, Oseltamivir Phosphate Capsules, and Levofloxacin Tablets.

Source: Menet Database

Note: The statistical date is based on the final status time of the CDE, and data statistics are as of July 29, 2019.

Original Title: 163 Approval Documents Passed Evaluation in the First Half of the Year, Achieving a Great Harvest! Qilu Pharmaceutical Leads, Humanwell and China Resources Surge Ahead...