YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 297 drug applications between 20 December 2021 and 26 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 44 drug names.

2021/12/20 – 2021/12/26

Period
2021/12/20 to 2021/12/26, 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
297
Drugs with new generic filings (by drug name, de-duplicated)
44
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

297filings, 64 of them generic

By application type

Application typeFilings
Supplement137
Generic64
New drug60
Import18
Unspecified10
Import re-registration8

By drug type

Drug typeFilings
Chemical drug204
Therapeutic biologic63
TCM23
In vitro diagnostic reagent4
Biologic2
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

44 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Febuxostat Tablets5312
2Bromfenac Sodium Eye Drops227
3Sodium Valproate Concentrated Solution for Injection210
4Elagolix Tablets212
5Ozagrel Sodium Injection213
6Torsemide Injection211
7Tegafur,Gimeracil and Oteracil Potassium Capsules210
8Nicorandil for Injection211
9Gemcitabine Hydrochloride for Injection211
10Sodium Hyaluronate Eye Drops2130

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

172 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Shuang He Pharma Co., Ltd. romanized1230
2Boehringer Ingelheim International GmbH720
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
4Novo Nordisk A/S620
5Lv Shi Zi (Zhongguo) Bio Zhi Pin Co., Ltd. romanized620
6Pfizer Europe MA EEIG540
7Qilu Pharmaceutical (Hainan) Co., Ltd535
8Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized440
9Novartis Pharma Schweiz AG430
10Haerbin Tian Mei Pharma Co., Ltd. romanized430

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

103 this week

AcceptedDrugApplicants
2021/12/24Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101151 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/12/24Import · Class 1 Enpatoran · No verified English nameJXHL2101287 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2021/12/24Import · Class 2.4 Belzutifan片 · No verified English nameJXHL2101285 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd.
2021/12/24Import · Class 1 LOXO-305片 · No verified English nameJXHL2101284 Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/12/24Import · Class 1 LOXO-305片 · No verified English nameJXHL2101283 Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/12/24Import · Class 1 LOXO-305片 · No verified English nameJXHL2101282 Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/12/24Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2102278 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2021/12/24Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2102277 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2021/12/24Generic · Class 3 Fluorouracil InjectionCYHS2102276 Jian Jin Pharmaceutical Co., Ltd. romanized
2021/12/24Generic · Class 3 Nicorandil for InjectionCYHS2102275 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2021/12/24Generic · Class 3 Nicorandil for InjectionCYHS2102274 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2021/12/24Generic · Class 3 Torsemide InjectionCYHS2102273 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized
2021/12/24Generic · Class 3 Torsemide InjectionCYHS2102272 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized
2021/12/24Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2102271 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2021/12/24New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSS2101086 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/12/24New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2101085 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/12/24New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2101508 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/12/24New drug · Class 1 SSGJ-707注射液 · No verified English nameCXSL2101507 Dan Sheng Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/12/24New drug · Class 1 XNW14010片 · No verified English nameCXHL2101811 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/12/24New drug · Class 1 XNW14010片 · No verified English nameCXHL2101810 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/12/24New drug · Class 1 NP107片 · No verified English nameCXHL2101809 Shanghai Na Wei Bio Technology Co., Ltd. romanized
2021/12/24New drug · Class 1 NP107片 · No verified English nameCXHL2101808 Shanghai Na Wei Bio Technology Co., Ltd. romanized
2021/12/23Import · Class 1 IMG-020注射液 · No verified English nameJXSL2101150 Affibody AB; Inmagene Biopharmaceuticals (Wuhan) Co. Ltd.
2021/12/23Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2102264 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2102263 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2102261 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2102258 Beijing Xin Mei Tai Ke Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Tian Rui Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 奥美拉唑碳酸氢钠胶囊(II) · No verified English nameCYHS2102257 Beijing Bai Ao Pharma Co., Ltd. romanized
2021/12/23Generic · Class 3 Compound Sulfamethoxazole TabletsCYHS2102256 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2021/12/23Generic · Class 3 Biapenem For InjectionCYHS2102250 Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized

73 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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