YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 336 drug applications between 20 August 2025 and 26 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 64 drug names.

2025/08/20 – 2025/08/26

Period
2025/08/20 to 2025/08/26, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
336
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
93

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

336filings, 90 of them generic

By application type

Application typeFilings
Supplement169
Generic90
New drug38
Import29
Unspecified5
Import re-registration5

By drug type

Drug typeFilings
Chemical drug235
TCM55
Therapeutic biologic41
Biologic2
Prophylactic biologic2
Unspecified1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sufentanil Citrate Injection410
2Fexofenadine Hydrochloride Tablets4110
3Magnesium Sulfate Injection327
4Memantine Hydrochloride OD Tablets312
5Polidocanol Injection3123
6Potassium Chloride Injection2210
7Apalutamide Tablets2218
8利伐沙班口崩片 · No verified English name214
9Lidocaine and Tetracaine Cream212
10左乙拉西坦微片 · No verified English name212

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

216 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1920
2NAPP PHARMACEUTICALS LIMITED910
3CSPC OUYI PHARMACEUTICAL CO., LTD.655
4AstraZeneca AB640
5Changchun Jin Sai Pharma Co., Ltd. romanized541
6Janssen-Cilag International NV520
7Jiangsu En Hua Pharma Co., Ltd. romanized524
8Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.410
9Sichuan Pharmaceutical Formulations Co., Ltd. romanized410
10Zhi En Bio Technology Co., Ltd. romanized414

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

106 this week

AcceptedDrugApplicants
2025/08/26Import · Class 1 AZD0486 · No verified English nameJXSL2500158 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/26Import · Class 1 AZD0486 · No verified English nameJXSL2500157 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/26Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2503131 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2025/08/26Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2503130 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2025/08/26Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2503129 Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2025/08/26Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2503127 Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized
2025/08/26Generic · Class 3 右酮洛芬氨丁三醇口服溶液 · No verified English nameCYHS2503126 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized
2025/08/26Generic · Class 3 Sulindac TabletsCYHS2503125 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/08/26Generic · Class 3 Vincriscristine Sulfate InjectionCYHS2503117 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2025/08/26Generic · Class 3 Simethicone Chewable TabletsCYHS2503116 Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized
2025/08/26Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2500154 Beijing Yi Cheng Pharmaceuticals Technology Co., Ltd. romanized
2025/08/26Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2500153 Beijing Yi Cheng Pharmaceuticals Technology Co., Ltd. romanized
2025/08/26Generic · Class 3 Sufentanil Citrate InjectionCYHL2500152 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/08/26Generic · Class 3 Sufentanil Citrate InjectionCYHL2500151 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/08/26Generic · Class 3 Sufentanil Citrate InjectionCYHL2500150 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/08/26Generic · Class 3 Sufentanil Citrate InjectionCYHL2500149 Jiangsu En Hua Pharma Co., Ltd. romanized
2025/08/26New drug · Class 1.1 痰火丸 · No verified English nameCXZL2500068 Shanghai Kai Bao Pharma Co., Ltd. romanized
2025/08/26New drug · Class 1 HBW-012462片 · No verified English nameCXHL2500889 Chengdu Hai Bo Wei Pharma Co., Ltd. romanized
2025/08/26New drug · Class 1 HBW-012462片 · No verified English nameCXHL2500888 Chengdu Hai Bo Wei Pharma Co., Ltd. romanized
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500237 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500236 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500235 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500234 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500233 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500232 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500231 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2500230 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/25Import · Class 2.4 英克司兰钠注射液 · No verified English nameJXHL2500229 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/08/25Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2503113 Hefei Hua Wei Pharma Co., Ltd. romanized
2025/08/25New drug · Class 1 SBK008注射液 · No verified English nameCXHL2500887 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized

76 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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