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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 415 drug applications between 9 December 2023 and 15 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 73 drug names.

2023/12/09 – 2023/12/15

Period
2023/12/09 to 2023/12/15, 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
415
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
0

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

415filings, 94 of them generic

By application type

Application typeFilings
Supplement209
Generic94
New drug65
Import28
Unspecified11
Import re-registration8

By drug type

Drug typeFilings
Chemical drug259
TCM89
Therapeutic biologic60
Biologic4
Prophylactic biologic2
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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1地氯雷他定口服溶液 · No verified English name3326
2Tapentadol Hydrochloride Tablets310
3二甲双胍恩格列净片(I) · No verified English name222
4Morinidazole and Sodium Chloride Injection229
5噻托溴铵吸入粉雾剂 · No verified English name222
6Diquafosol Sodium Eye Drops225
7Vortioxetine Hydrobromide Tablets2210
8Norepinephrine Bitartrate Injection229
9Acetylcysteine Oral Solution2111
10复方醋酸钠林格注射液 · 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

231 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Lan Yun Zhi He Bio Technology Co., Ltd. romanized31250
2Novo Nordisk A/S1010
3Tai Ji Group Sichuan Tian Cheng Pharmaceutical Co., Ltd. romanized880
4Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized820
5Qi Lu An Ti Pharmaceutical Co., Ltd. romanized660
6Fresenius Kabi Austria GmbH610
7Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized542
8Hunan Ke Lun Pharmaceutical Co., Ltd. romanized544
9Guangdong Ke Hong Pharma Co., Ltd. romanized535
10Kang Zhi Pharma Co., Ltd. romanized530

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

134 this week

AcceptedDrugApplicants
2023/12/15Import · Class 3.1 阿柏西普眼内注射溶液 · No verified English nameJXSS2300092 Bayer AG; Vetter Pharma-Fertigung GmbH & Co. KG; Bayer Healthcare Company Ltd.
2023/12/15Import · Class 1 AZD0486 · No verified English nameJXSL2300229 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/12/15Generic · Class 3 Acetylcysteine InjectionCYHS2303489 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/12/15Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2303488 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2023/12/15Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2303486 Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/12/15Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2303485 Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/12/15Generic · Class 3 Desonide CreamCYHS2303480 Hebei Xin Zhang Yao Co., Ltd. romanized; Hebei Ya Dong Pharmaceutical Co., Ltd. romanized
2023/12/15Generic · Class 3 Potassium Chloride GranulesCYHS2303479 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/12/15Generic · Class 3 Ursodeoxycholic Acid TabletsCYHS2303478 Zhong Shan Li Gao Biopharmaceuticals Co., Ltd. romanized; An Shi Pharmaceutical (Zhong Shan) Co., Ltd. romanized
2023/12/15New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSL2300862 Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized
2023/12/15New drug · Class 1 LP-005 注射液 · No verified English nameCXSL2300861 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/12/15New drug · Class 1 甲磺酸瑞厄替尼片 · No verified English nameCXHS2300115 Nanjing Sheng He Pharma Co., Ltd. romanized
2023/12/15New drug · Class 2.2 LPC-008口溶膜 · No verified English nameCXHL2301397 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/15New drug · Class 2.2 LPC-008口溶膜 · No verified English nameCXHL2301396 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/15New drug · Class 2.2 LPC-008口溶膜 · No verified English nameCXHL2301395 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/12/15New drug · Class 1 68Ga-NYM032注射液制备用药盒 · No verified English nameCXHL2301394 Wuxi Nuo Yu Pharmaceuticals Technology Co., Ltd. romanized
2023/12/15New drug · Class 1 KBP-2205片 · No verified English nameCXHL2301393 Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2023/12/15New drug · Class 1 KBP-2205片 · No verified English nameCXHL2301392 Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2023/12/15New drug · Class 1 XS-02胶囊 · No verified English nameCXHL2301391 Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized
2023/12/15New drug · Class 1 XS-02胶囊 · No verified English nameCXHL2301390 Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized
2023/12/14Import · Class 1 Cevostamab · No verified English nameJXSL2300228 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2023/12/14Import · Class 2.2 Pozelimab注射液 · No verified English nameJXSL2300227 Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd.
2023/12/14Import · Class 2.2 Pozelimab注射液 · No verified English nameJXSL2300226 Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd.
2023/12/14Import · Class 1 Cemdisiran注射液 · No verified English nameJXHL2300314 Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd.
2023/12/14Import · Class 1 Cemdisiran注射液 · No verified English nameJXHL2300313 Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd
2023/12/14Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303473 Hubei Kai Na Pharma Co., Ltd. romanized; Hubei Mei Si Chuang Pharma Co., Ltd. romanized
2023/12/14Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2303469 Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized; Bao Ding Ai Hui Pharma Co., Ltd. romanized
2023/12/14Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2303468 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2023/12/14Generic · Class 3 Nefopam Hydrochloride InjectionCYHS2303467 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2023/12/14Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2303464 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized

104 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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