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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 375 drug applications between 10 December 2023 and 16 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 61 drug names.

2023/12/10 – 2023/12/16

Period
2023/12/10 to 2023/12/16, 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
375
Drugs with new generic filings (by drug name, de-duplicated)
61
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

375filings, 78 of them generic

By application type

Application typeFilings
Supplement196
Generic78
New drug64
Import24
Unspecified8
Import re-registration5

By drug type

Drug typeFilings
Chemical drug240
TCM75
Therapeutic biologic58
Biologic1
Prophylactic 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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tapentadol Hydrochloride Tablets310
2二甲双胍恩格列净片(I) · No verified English name222
3Morinidazole and Sodium Chloride Injection229
4噻托溴铵吸入粉雾剂 · No verified English name222
5Diquafosol Sodium Eye Drops225
6地氯雷他定口服溶液 · No verified English name2226
7Vortioxetine Hydrobromide Tablets2210
8Potassium Chloride Granules224
9Norepinephrine Bitartrate Injection229
10Acetylcysteine Oral Solution2111

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

209 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Lan Yun Zhi He Bio Technology Co., Ltd. romanized14130
2Novo Nordisk A/S1010
3Tai Ji Group Sichuan Tian Cheng Pharmaceutical Co., Ltd. romanized880
4Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized820
5Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized720
6Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized660
7Qi Lu An Ti Pharmaceutical Co., Ltd. romanized660
8Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized652
9Novartis Pharma Schweiz AG630
10Fresenius Kabi Austria GmbH610

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

119 this week

AcceptedDrugApplicants
2023/12/16Import · Class 3.1 注射用Andexanet alfa · No verified English nameJXSS2300093 AstraZeneca AB; Baxter Pharmaceutical Solutions LLC; AstraZeneca Global R&D (China) Co. Ltd.
2023/12/16Import · Class 2.4 MRTX849片 · No verified English nameJXHL2300315 Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2023/12/16Generic · Class 3 Lysine Acetylsalicylate For InjectionCYHS2303496 Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD
2023/12/16Generic · Class 3 Diprophylline InjectionCYHS2303495 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2023/12/16Generic · Class 3 Potassium Chloride GranulesCYHS2303494 Nanjing Hai Jing Pharma Co., Ltd. romanized
2023/12/16Generic · Class 3 盐酸氨酮戊酸颗粒剂 · No verified English nameCYHL2300154 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2023/12/16New drug · Class 1 口服重组人糜蛋白酶冻干粉 · No verified English nameCXSL2300868 Wuhan He Yuan Bio Technology Co., Ltd. romanized
2023/12/16New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2300867 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/12/16New drug · Class 1 SYSA1801注射液 · No verified English nameCXSL2300866 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2023/12/16New drug · Class 1 LVGN6051单克隆抗体注射液 · No verified English nameCXSL2300865 Li Jin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/12/16New drug · Class 3.3 KH917注射液 · No verified English nameCXSL2300864 Beijing Kang Hong Biopharmaceuticals Co., Ltd. romanized
2023/12/16New drug · Class 1 注射用TQB2930 · No verified English nameCXSL2300863 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/12/16New drug · Class 2.2 HQ-0124片 · No verified English nameCXHS2300117 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/12/16New drug · Class 2.2 HQ-0124片 · No verified English nameCXHS2300116 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2023/12/16New drug · Class 1 CB06-036 · No verified English nameCXHL2301402 Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized
2023/12/16New drug · Class 1 CB06-036 · No verified English nameCXHL2301401 Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized
2023/12/16New drug · Class 1 IAMA-001鼻用喷雾剂 · No verified English nameCXHL2301400 Nanjing Ji Sheng Ao Ma Biopharmaceuticals Co., Ltd. romanized
2023/12/16New drug · Class 1 IAMA-001鼻用喷雾剂 · No verified English nameCXHL2301399 Nanjing Ji Sheng Ao Ma Biopharmaceuticals Co., Ltd. romanized
2023/12/16New drug · Class 1 IAMA-001鼻用喷雾剂 · No verified English nameCXHL2301398 Nanjing Ji Sheng Ao Ma Biopharmaceuticals Co., Ltd. romanized
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

89 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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