YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 292 drug applications between 21 December 2021 and 27 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 41 drug names.

2021/12/21 – 2021/12/27

Period
2021/12/21 to 2021/12/27, 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
292
Drugs with new generic filings (by drug name, de-duplicated)
41
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

292filings, 62 of them generic

By application type

Application typeFilings
Supplement133
Generic62
New drug58
Import18
Unspecified13
Import re-registration8

By drug type

Drug typeFilings
Chemical drug198
Therapeutic biologic62
TCM22
In vitro diagnostic reagent4
Biologic4
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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Febuxostat Tablets5312
2Sitagliptin Phosphate Tablets422
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
10Urapidil Hydrochloride Injection216

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

169 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Shuang He Pharma Co., Ltd. romanized1230
2Boehringer Ingelheim International GmbH720
3Novo Nordisk A/S620
4Shanghai Ying Li Pharma Co., Ltd. romanized620
5Lv Shi Zi (Zhongguo) Bio Zhi Pin Co., Ltd. romanized620
6Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized440
7Pfizer Europe MA EEIG430
8Haerbin Tian Mei Pharma Co., Ltd. romanized430
9Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized410
10Chengdu Di Yi Pharmaceutical Co., Ltd. romanized410

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

100 this week

AcceptedDrugApplicants
2021/12/27Import · Class 1 Enpatoran · No verified English nameJXHL2101286 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2021/12/27Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2102285 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2021/12/27Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2102284 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2021/12/27Generic · Class 3 Tranexamic Acid InjectionCYHS2102283 Jilin Si Zhang Pharmaceutical Co., Ltd. romanized
2021/12/27New drug · Class 3.4 聚乙二醇重组人粒细胞刺激因子注射液 · No verified English nameCXSS2101082 Beijing SL Pharmaceutical Co., Ltd.
2021/12/27New drug · Class 3.4 聚乙二醇重组人粒细胞刺激因子注射液 · No verified English nameCXSS2101081 Beijing SL Pharmaceutical Co., Ltd.
2021/12/27New drug · Class 3.4 变应原皮肤点刺试验对照液 · No verified English nameCXSS2101080 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2021/12/27New drug · Class 1 黄花蒿花粉点刺液 · No verified English nameCXSS2101079 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2021/12/27New drug · Class 1 白桦花粉点刺液 · No verified English nameCXSS2101078 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2021/12/27New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101511 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/12/27New drug · Class 2.5 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2101503 Changchun Zhuo Yi Bio Co., Ltd. romanized
2021/12/27New drug · Class 3.3 吸附无细胞百白破/b型流感嗜血杆菌联合疫苗 · No verified English nameCXSL2101502 Yu Xi Wo Sen Bio Technology Co., Ltd. romanized; Yunnan Wo Sen Bio Technology Co., Ltd. romanized
2021/12/27New drug · Class 2.4 镥[177Lu]氧奥曲肽注射液 · No verified English nameCXHL2101814 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2021/12/27New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2101813 Henan Mai Ying Nuo Pharmaceuticals Technology Co., Ltd. romanized
2021/12/27New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2101812 Henan Mai Ying Nuo Pharmaceuticals Technology Co., Ltd. romanized
2021/12/27New drug · Class 1 CX510片 · No verified English nameCXHL2101807 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
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

70 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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