YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 258 drug applications between 28 October 2022 and 3 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 38 drug names.

2022/10/28 – 2022/11/03

Period
2022/10/28 to 2022/11/03, 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
258
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
1

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

258filings, 48 of them generic

By application type

Application typeFilings
Supplement114
Generic48
New drug44
Import25
Import re-registration17
Unspecified10

By drug type

Drug typeFilings
Chemical drug189
Therapeutic biologic40
TCM26
Prophylactic biologic2
Biologic1

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Injection228
2Olaparib Tablets210
3Empagliflozin Tablets2118
4Urapidil Hydrochloride Injection216
5Ambroxol Hydrochloride Drops218
6Magnesium Sulfate Injection217
7羟乙基淀粉130/0.4氯化钠注射液 · No verified English name210
8Esomeprazole Magnesium Enteric-Coated Capsules214
9Dapagliflozin Tablets2184
10Norepinephrine Bitartrate Injection219

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

143 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1020
2Hubei Mei Lin Pharma Co., Ltd. romanized960
3Guangdong Dong Yang Guang Pharma Co., Ltd. romanized910
4Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized660
5Annora Pharma Private Limited620
6Shandong Han Fang Pharmaceutical Co., Ltd. romanized550
7Boehringer Ingelheim International GmbH530
8Anhui Mei Yu Pharmaceutical Co., Ltd. romanized530
9Qilu Pharmaceutical Co., Ltd.532
10Chengdu Shi Hai Tong Pharma Co., Ltd. romanized520

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

84 this week

AcceptedDrugApplicants
2022/11/03Generic · Class 3 Nimodipine Oral SolutionCYHS2201882 Shanghai Ao Quan Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2022/11/03New drug · Class 2.3 阿利沙坦酯氨氯地平片 · No verified English nameCXHS2200061 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/03New drug · Class 1 BPI-452080 片 · No verified English nameCXHL2200865 Bei Da Pharma Co., Ltd. romanized
2022/11/03New drug · Class 1 BPI-452080 片 · No verified English nameCXHL2200864 Bei Da Pharma Co., Ltd. romanized
2022/11/02Import · Class 2.4 亮丙瑞林注射乳剂 · No verified English nameJXHL2200328 Foresee Pharmaceuticals Co. Ltd; Changchun GeneScience Pharmaceuticals Co. Ltd.
2022/11/02Import · Class 2.2; 2.4 CBT-001眼用乳液 · No verified English nameJXHL2200327 Cloudbreak Therapeutics LLC; Cloudbreak Bio-Pharmaceutical Science and Technology(Guangzhou)Co. Ltd
2022/11/02Import · Class 2.2; 2.4 CBT-001眼用乳液 · No verified English nameJXHL2200326 Cloudbreak Therapeutics LLC; Cloudbreak Bio-Pharmaceutical Science and Technology(Guangzhou)Co. Ltd
2022/11/02Import · Class 1 SAR443122 硬胶囊 · No verified English nameJXHL2200325 Sanofi-Aventis Recherche & Développement
2022/11/02Import · Class 1 SAR443122 硬胶囊 · No verified English nameJXHL2200324 Sanofi-Aventis Recherche & Développement
2022/11/02Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2201876 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2022/11/02New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSS2200089 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2022/11/02New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSS2200088 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2022/11/02New drug · Class 1 注射用SHR-A1921 · No verified English nameCXSL2200556 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/11/02New drug · Class 1 阿得贝利单抗注射液 · No verified English nameCXSL2200555 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/11/02New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2200554 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/11/02New drug · Class 1 注射用间充质干细胞(脐带) · No verified English nameCXSL2200553 Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized
2022/11/02New drug · Class 1 ZLT-001注射液 · No verified English nameCXSL2200552 Guangzhou Zhi Ling Biopharmaceuticals Co., Ltd. romanized
2022/11/02New drug · Class 2.2 利培酮口溶膜 · No verified English nameCXHS2200060 Qilu Pharmaceutical Co., Ltd.
2022/11/02New drug · Class 2.2 利培酮口溶膜 · No verified English nameCXHS2200059 Qilu Pharmaceutical Co., Ltd.
2022/11/02New drug · Class 1 BGT-002片 · No verified English nameCXHL2200863 Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2022/11/02New drug · Class 1 BGT-002片 · No verified English nameCXHL2200862 Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2022/11/02New drug · Class 1 TDI01混悬液 · No verified English nameCXHL2200861 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2022/11/02New drug · Class 2.4 奥布替尼片 · No verified English nameCXHL2200860 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2022/11/02New drug · Class 2.2 枸橼酸西地那非分散片 · No verified English nameCXHL2200858 Shanghai Ao Quan Biopharmaceuticals Technology Co., Ltd. romanized
2022/11/01Import · Class 1 BION-1301注射液 · No verified English nameJXSL2200190 Chinook Therapeutics Inc.; SanReno Therapeutics (Shanghai) Limited
2022/11/01Import · Class 1 KarXT胶囊 · No verified English nameJXHL2200323 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/11/01Import · Class 1 KarXT胶囊 · No verified English nameJXHL2200322 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/11/01Import · Class 1 KarXT胶囊 · No verified English nameJXHL2200321 Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/11/01Import · Class 1 AZD2693注射液 · No verified English nameJXHL2200320 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/11/01Import · Class 1 AZD2693注射液 · No verified English nameJXHL2200319 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.

54 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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