YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 336 drug applications between 4 September 2024 and 10 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 76 drug names.

2024/09/04 – 2024/09/10

Period
2024/09/04 to 2024/09/10, 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
336
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
4

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

336filings, 106 of them generic

By application type

Application typeFilings
Supplement142
Generic106
New drug57
Import18
Import re-registration10
Unspecified3

By drug type

Drug typeFilings
Chemical drug222
TCM66
Therapeutic biologic43
Prophylactic biologic4
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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Hyaluronate Eye Drops3230
2Brexpiprazole Orally Disintegrating Tablets3110
3Erythromycin Lactobionate for Injection3113
4Acetylcysteine Solution For Inhalation224
5Levocarnitine Injection224
6Bilastine Tablets227
7Tranexamic Acid Tablets229
8氯化钙注射液 · No verified English name226
9Nicardipine Hydrochloride Injection2213
10Glucosamine Sulfate Capsules2251

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

213 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

108 this week

AcceptedDrugApplicants
2024/09/10Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402992 E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2024/09/10Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2402990 Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized
2024/09/10Generic · Class 3 Sulindac TabletsCYHS2402986 Chengdu Tong De Pharma Co., Ltd. romanized
2024/09/10Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2402980 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2024/09/10Generic · Class 3 Methotrexate TabletsCYHS2402978 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Shenzhen Wan Le Pharma Co., Ltd. romanized
2024/09/10Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2402975 Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2024/09/10Generic · Class 3 Cimetidine InjectionCYHS2402968 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2024/09/10New drug · Class 1.1 芩葛退热解毒颗粒 · No verified English nameCXZL2400050 Name not romanized
2024/09/10New drug · Class 1 GKL-006注射液 · No verified English nameCXSL2400602 Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized
2024/09/10New drug · Class 1 注射用SHR-4394 · No verified English nameCXSL2400601 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/09/10New drug · Class 1 PJ016注射液 · No verified English nameCXSL2400600 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2024/09/10New drug · Class 1 IN10018片 · No verified English nameCXHL2400938 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2024/09/10New drug · Class 1 IN10018片 · No verified English nameCXHL2400937 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2024/09/10New drug · Class 1 注射用PL002 · No verified English nameCXHL2400936 Zhejiang Pu Li Pharma Co., Ltd. romanized
2024/09/10New drug · Class 1 SS-001 软膏 · No verified English nameCXHL2400935 Suzhou Pai Rui Bio Technology Co., Ltd. romanized
2024/09/10New drug · Class 1 SS-001 软膏 · No verified English nameCXHL2400934 Suzhou Pai Rui Bio Technology Co., Ltd. romanized
2024/09/10New drug · Class 1 SS-001 软膏 · No verified English nameCXHL2400933 Suzhou Pai Rui Bio Technology Co., Ltd. romanized
2024/09/10New drug · Class 1 BGB-58067片 · No verified English nameCXHL2400932 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/09/10New drug · Class 1 BGB-58067片 · No verified English nameCXHL2400931 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/09/10New drug · Class 1 GW117片 · No verified English nameCXHL2400930 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2024/09/10New drug · Class 1 D-1553片 · No verified English nameCXHL2400929 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/09/10New drug · Class 2.2 HY-2003 · No verified English nameCXHL2400928 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2024/09/09Generic · Class 3 Vitamin K1 InjectionCYHS2402966 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/09/09Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2402965 Haerbin Shi Kang Long Pharma Co., Ltd. romanized
2024/09/09Generic · Class 3 Trelagliptin Succinate TabletsCYHS2402964 Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized
2024/09/09Generic · Class 3 Trelagliptin Succinate TabletsCYHS2402963 Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized
2024/09/07Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2402962 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2024/09/07Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2402961 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2024/09/07Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2402960 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2024/09/07Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2402959 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized

78 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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