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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 293 drug applications between 3 September 2024 and 9 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 67 drug names.

2024/09/03 – 2024/09/09

Period
2024/09/03 to 2024/09/09, 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
293
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
2

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

293filings, 89 of them generic

By application type

Application typeFilings
Supplement123
Generic89
New drug51
Import19
Import re-registration9
Unspecified2

By drug type

Drug typeFilings
Chemical drug188
TCM62
Therapeutic biologic38
Prophylactic biologic5

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

67 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
4Levocarnitine Injection224
5氯化钙注射液 · No verified English name226
6Nicardipine Hydrochloride Injection2213
7Glucosamine Sulfate Capsules2251
8维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.223
9Tadalafil Tablets2123
10依伏卡塞片 · No verified English name219

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

181 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized11110
2Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized990
3AstraZeneca AB520
4Hua Run Shuang He Pharma Co., Ltd. romanized510
5Anhui Pioneer Pharmaceutical Co., Ltd433
6Janssen-Cilag International NV420
7Novartis Pharma Schweiz AG420
8Ren He Yi Kang Group Co., Ltd. romanized422
9Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized424
10ASPEN PHARMA TRADING LIMITED410

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

99 this week

AcceptedDrugApplicants
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
2024/09/07Generic · Class 3 Potassium Phosphates InjectionCYHS2402957 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/09/07Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2402954 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2024/09/07Generic · Class 3 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2402953 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/09/07Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2402952 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2024/09/07Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2402951 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2024/09/07Generic · Class 3 Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2402944 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/09/07New drug · Class 1 LP-003 注射液 · No verified English nameCXSL2400599 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2024/09/07New drug · Class 1 SHR-3045注射液 · No verified English nameCXSL2400598 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/09/07New drug · Class 1 聚乙二醇化重组门冬酰胺酶注射液 · No verified English nameCXSL2400597 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2024/09/07New drug · Class 2.2 ZC2211 · No verified English nameCXHL2400927 Hangzhou Zhi Cheng Technology Co., Ltd. romanized
2024/09/07New drug · Class 2.2 ZC2211 · No verified English nameCXHL2400926 Hangzhou Zhi Cheng Technology Co., Ltd. romanized
2024/09/07New drug · Class 1 JMKX003676片 · No verified English nameCXHL2400925 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2024/09/07New drug · Class 1 JMKX003676片 · No verified English nameCXHL2400924 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2024/09/07New drug · Class 1 KPC000154片 · No verified English nameCXHL2400923 Kun Yao Group Co., Ltd. romanized; Kun Yao Group (Zhuhai Heng Qin) Technology Co., Ltd. romanized
2024/09/07New drug · Class 1 KPC000154片 · No verified English nameCXHL2400922 Kun Yao Group Co., Ltd. romanized; Kun Yao Group (Zhuhai Heng Qin) Technology Co., Ltd. romanized
2024/09/07New drug · Class 1 JMKX003676片 · No verified English nameCXHL2400921 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2024/09/07New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2400920 Hua Run Shuang He Pharma Co., Ltd. romanized
2024/09/07New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2400919 Hua Run Shuang He Pharma Co., Ltd. romanized
2024/09/07New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2400918 Hua Run Shuang He Pharma Co., Ltd. romanized
2024/09/07New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2400917 Hua Run Shuang He Pharma Co., Ltd. romanized
2024/09/07New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2400916 Hua Run Shuang He Pharma Co., Ltd. romanized
2024/09/06Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2402939 Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized

69 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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