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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 183 drug applications between 20 March 2024 and 26 March 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 48, covering 39 drug names.

2024/03/20 – 2024/03/26

Period
2024/03/20 to 2024/03/26, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
183
Drugs with new generic filings (by drug name, de-duplicated)
39
Accepted this week, now under review
1

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

183filings, 48 of them generic

By application type

Application typeFilings
Supplement91
Generic48
New drug29
Import9
Unspecified4
Import re-registration2

By drug type

Drug typeFilings
Chemical drug117
TCM40
Therapeutic biologic23
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

39 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Morinidazole and Sodium Chloride Injection229
3Potassium Phosphates Injection222
4Nicorandil for Injection221
5Glucosamine Sulfate Capsules2251
6Brivaracetam Tablets2119
7Ambroxol Hydrochloride Oral Solution2148
8Sugammadex Sodium Injection216
9Crisaborole Ointment1126
10Lidocaine and Tetracaine Cream112

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

123 companies with new acceptances; top 10 listed

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

53 this week

AcceptedDrugApplicants
2024/03/26Import · Class 2.4 LNP023胶囊 · No verified English nameJXHL2400067 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/03/26Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2400913 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2024/03/26Generic · Class 3 Milrinone InjectionCYHS2400910 Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2024/03/26Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2400907 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2024/03/26Generic · Class 3 Brivaracetam TabletsCYHL2400065 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/03/26Generic · Class 3 Brivaracetam TabletsCYHL2400064 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/03/26New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2400304 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/26New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2400303 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/26New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2400302 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/03/26New drug · Class 1 HRS7415片 · No verified English nameCXHL2400301 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/03/26New drug · Class 1 HRS-8080片 · No verified English nameCXHL2400300 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/26New drug · Class 1 HRS-8080片 · No verified English nameCXHL2400299 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/25Generic · Class 3 Amisulpride Oral SolutionCYHS2400906 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2024/03/25Generic · Class 3 Furosemide InjectionCYHS2400905 Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2024/03/23Import · Class 1 MK-7240注射用浓溶液 · No verified English nameJXSL2400063 Merck Sharp & Dohme LLC; Name not romanized
2024/03/23Import · Class 1 MK-7240注射液 · No verified English nameJXSL2400062 Merck Sharp & Dohme LLC; Name not romanized
2024/03/23Import · Class 1 Budigalimab · No verified English nameJXSL2400061 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/03/23Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2400900 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/03/23Generic · Class 3 Nicorandil for InjectionCYHS2400899 Guangdong Hai He Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2024/03/23Generic · Class 3 Potassium Phosphates InjectionCYHS2400897 Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/03/23Generic · Class 3 盐酸尼卡地平氯化钠注射液 · No verified English nameCYHS2400895 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/03/23Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2400063 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2024/03/23New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2400202 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/03/23New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2400201 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/03/23New drug · Class 1 HCB101注射液 · No verified English nameCXSL2400200 Guangzhou Han Ke Bio Co., Ltd. romanized
2024/03/22Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2400892 Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized
2024/03/22Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2400890 Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2024/03/22Generic · Class 3 Nicorandil for InjectionCYHS2400889 Fuzhou Hua Wei Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2024/03/22New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2400027 Jiangsu Kang Run Bio Technology Co., Ltd. romanized
2024/03/22New drug · Class 1 盐酸杰克替尼片 · No verified English nameCXHL2400298 Name not romanized

23 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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