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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 381 drug applications between 14 December 2023 and 20 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 79 drug names.

2023/12/14 – 2023/12/20

Period
2023/12/14 to 2023/12/20, 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
381
Drugs with new generic filings (by drug name, de-duplicated)
79
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

381filings, 101 of them generic

By application type

Application typeFilings
Supplement181
Generic101
New drug62
Import18
Unspecified14
Import re-registration5

By drug type

Drug typeFilings
Chemical drug268
TCM67
Therapeutic biologic42
Biologic3
In vitro diagnostic reagent1

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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diquafosol Sodium Eye Drops435
2Tapentadol Hydrochloride Tablets310
3Lactulose Oral Solution2234
4二甲双胍恩格列净片(I) · No verified English name222
5Morinidazole and Sodium Chloride Injection229
6Vortioxetine Hydrobromide Tablets2210
7Potassium Chloride Granules224
8Mecobalamin Tablets2216
9Dopamine Hydrochloride Injection223
10Brimonidine Tartrate Eye Drops224

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

227 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized13130
2Lan Yun Zhi He Bio Technology Co., Ltd. romanized870
3Novartis Pharma Schweiz AG740
4Hainan Xu Wo Pharma Co., Ltd. romanized660
5Qi Lu An Ti Pharmaceutical Co., Ltd. romanized660
6AstraZeneca AB650
7Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized620
8Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized552
9Kang Zhi Pharma Co., Ltd. romanized530
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520

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

116 this week

AcceptedDrugApplicants
2023/12/20Import · Class 1 A24110He注射液 · No verified English nameJXHL2300318 Lipigon Pharmaceuticals AB; Leaderna Therapeutics Ltd
2023/12/20Import · Class 1 Zibotentan达格列净片 · No verified English nameJXHL2300317 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/12/20Import · Class 1 Zibotentan达格列净片 · No verified English nameJXHL2300316 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/12/20Generic · Class 3 Pentoxifylline InjectionCYHS2303537 Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/12/20Generic · Class 3 注射用比阿培南/氯化钠注射液 · No verified English nameCYHS2303536 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/20Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303534 Hunan Hai Shi Biopharmaceuticals Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2023/12/20New drug · Class 1.1 芪参颗粒 · No verified English nameCXZL2300074 Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized
2023/12/20New drug · Class 1 K1注射液 · No verified English nameCXSL2300872 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2023/12/20New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2300871 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2023/12/20New drug · Class 2.2 LPC-008 口溶膜 · No verified English nameCXHL2301421 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/20New drug · Class 2.2 LPC-008 口溶膜 · No verified English nameCXHL2301420 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/20New drug · Class 2.2 LPC-008 口溶膜 · No verified English nameCXHL2301419 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/20New drug · Class 2.3 LH-2103胶囊 · No verified English nameCXHL2301418 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2023/12/19Import · Class 2.4 琥珀酸瑞波西利片 · No verified English nameJXHS2300126 Novartis Pharma Schweiz AG; Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd.; Beijing Novartis Pharma Co. Ltd.
2023/12/19Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2303523 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2023/12/19Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2303519 Chongqing Jian Neng Pharmaceuticals Kai Fa Co., Ltd. romanized; Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2303518 Chongqing Jian Neng Pharmaceuticals Kai Fa Co., Ltd. romanized; Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2303511 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2023/12/19Generic · Class 3 Isoniazid InjectionCYHS2303510 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 Ibuprofen GranulesCYHS2303506 Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 Famotidine InjectionCYHS2303505 Fujian Tian Quan Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2023/12/19Generic · Class 3 Levofloxacin Oral SolutionCYHS2303504 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 Nicorandil for InjectionCYHS2303502 Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 Nicorandil for InjectionCYHS2303501 Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 Minoxidil LinimentCYHS2303498 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/12/19Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300155 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2023/12/19New drug · Class 1.2 注射用羟基红花黄色素A · No verified English nameCXZS2300027 Yue Kang Pharma Group Co., Ltd. romanized
2023/12/19New drug · Class 1.2 羟基红花黄色素A · No verified English nameCXZS2300026 Guangzhou Yue Kang Biopharmaceutical Co., Ltd. romanized
2023/12/19New drug · Class 3.3 阿达木单抗注射液 · No verified English nameCXSS2300100 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/12/19New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2300870 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized

86 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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