YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 283 drug applications between 27 October 2022 and 2 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 40 drug names.

2022/10/27 – 2022/11/02

Period
2022/10/27 to 2022/11/02, 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
283
Drugs with new generic filings (by drug name, de-duplicated)
40
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

283filings, 51 of them generic

By application type

Application typeFilings
Supplement123
Generic51
New drug46
Import28
Import re-registration19
Unspecified16

By drug type

Drug typeFilings
Chemical drug202
Therapeutic biologic44
TCM28
Biologic6
Prophylactic biologic3

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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Injection228
2Olaparib Tablets210
3Empagliflozin Tablets2118
4Flumazenil Injection212
5Urapidil Hydrochloride Injection216
6Ambroxol Hydrochloride Drops218
7Magnesium Sulfate Injection217
8羟乙基淀粉130/0.4氯化钠注射液 · No verified English name210
9Esomeprazole Magnesium Enteric-Coated Capsules214
10Dapagliflozin Tablets2184

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

161 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Mei Lin Pharma Co., Ltd. romanized960
2Novo Nordisk A/S910
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
7Anhui Mei Yu Pharmaceutical Co., Ltd. romanized530
8Qilu Pharmaceutical Co., Ltd.532
9Chengdu Shi Hai Tong Pharma Co., Ltd. romanized520
10Ren He Yi Kang Group Co., Ltd. romanized420

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

93 this week

AcceptedDrugApplicants
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.
2022/11/01Generic · Class 3 Fluconazole TabletsCYHS2201872 Shandong Fang Ming Pharma Group Co., Ltd. romanized
2022/11/01Generic · Class 3 Doxofylline GranulesCYHS2201871 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/11/01Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201868 Le Pu Pharma Co., Ltd. romanized
2022/11/01Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2201867 Le Pu Pharma Co., Ltd. romanized

63 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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