YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 307 drug applications between 30 December 2023 and 5 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 58 drug names.

2023/12/30 – 2024/01/05

Period
2023/12/30 to 2024/01/05, 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
307
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
2

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

307filings, 81 of them generic

By application type

Application typeFilings
Supplement153
Generic81
New drug50
Import14
Unspecified6
Import re-registration3

By drug type

Drug typeFilings
Chemical drug229
TCM40
Therapeutic biologic36
Prophylactic biologic2

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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Minoxidil Liniment4252
3Citicoline Injection310
4Levofloxacin Tablets227
5氯化钙注射液 · No verified English name226
6腺苷钴胺胶囊 · No verified English name228
7中/长链脂肪乳注射液(C6~24) · No verified English name210
8Acetylcysteine Oral Solution2111
9Lactulose Oral Solution2134
10Divalproex Sodium Extended-Release Tablets210

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

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized880
2Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized810
3Yi Chang Ren Fu Pharma Co., Ltd. romanized533
4Bei Da Pharma Co., Ltd. romanized520
5Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized440
6Nanjing Healthnice Pharmaceutical Technology Co., Ltd430
7Zhejiang Hua Yuan Pharma Co., Ltd. romanized432
8Eli Lilly and Company420
9CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420
10Xizang Bang Chen Pharma 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

95 this week

AcceptedDrugApplicants
2024/01/05Import · Class 1 Tarlatamab · No verified English nameJXSL2400006 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/01/05Import · Class 1 Tarlatamab · No verified English nameJXSL2400005 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/01/05Import · Class 1 Tarlatamab · No verified English nameJXSL2400004 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/01/05Import · Class 2.2 TAR-200 · No verified English nameJXHL2400002 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/01/05Generic · Class 3 Diprophylline InjectionCYHS2400067 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2024/01/05Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2400066 Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/01/05Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2400065 Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/01/05Generic · Class 3 Acetylcysteine Oral SolutionCYHS2400064 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2024/01/05Generic · Class 3 Acetylcysteine Oral SolutionCYHS2400063 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2024/01/05Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2400054 Shandong Ke Lun Pharma Co., Ltd. romanized
2024/01/05Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2400053 Shandong Ke Lun Pharma Co., Ltd. romanized
2024/01/05Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2400051 Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/01/05Generic · Class 3 Divalproex Sodium Extended-Release TabletsCYHL2400004 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/01/05Generic · Class 3 Divalproex Sodium Extended-Release TabletsCYHL2400003 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/01/05New drug · Class 3.1 温经汤颗粒 · No verified English nameCXZS2400001 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2024/01/05New drug · Class 2.2 卡度尼利单抗注射液 · No verified English nameCXSS2400003 Kang Fang Pharma Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2024/01/05New drug · Class 1 SKG0106眼内注射溶液 · No verified English nameCXSL2400009 Lan Yue Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2024/01/05New drug · Class 2.4 索凡替尼胶囊 · No verified English nameCXHL2400018 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2024/01/05New drug · Class 1 TQB3006片 · No verified English nameCXHL2400017 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/01/05New drug · Class 2.4 注射用磷丙泊酚二钠 · No verified English nameCXHL2400016 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/01/05New drug · Class 2.4 注射用磷丙泊酚二钠 · No verified English nameCXHL2400015 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/01/05New drug · Class 1 BPI-221351片 · No verified English nameCXHL2400014 Bei Da Pharma Co., Ltd. romanized
2024/01/05New drug · Class 1 BPI-221351片 · No verified English nameCXHL2400013 Bei Da Pharma Co., Ltd. romanized
2024/01/05New drug · Class 1 BPI-520105片 · No verified English nameCXHL2400012 Bei Da Pharma Co., Ltd. romanized
2024/01/05New drug · Class 1 BPI-520105片 · No verified English nameCXHL2400011 Bei Da Pharma Co., Ltd. romanized
2024/01/05New drug · Class 1 BPI-520105片 · No verified English nameCXHL2400010 Bei Da Pharma Co., Ltd. romanized
2024/01/04Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2400003 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/01/04Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2400002 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/01/04Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400050 Fujian Sheng Yi Long Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Wan Run Pharma Co., Ltd. romanized
2024/01/04Generic · Class 3 Minoxidil LinimentCYHS2400046 Hefei Hua Wei Pharma Co., Ltd. romanized

65 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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