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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 292 drug applications between 23 May 2024 and 29 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 62 drug names.

2024/05/23 – 2024/05/29

Period
2024/05/23 to 2024/05/29, 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)
62
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, 74 of them generic

By application type

Application typeFilings
Supplement132
Generic74
New drug51
Import re-registration18
Import13
Unspecified4

By drug type

Drug typeFilings
Chemical drug186
TCM58
Therapeutic biologic44
Prophylactic biologic4

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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bupivacaine Hydrochloride Injection424
2Lactulose Oral Solution2134
3复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液 · No verified English name210
4Nicergoline Tablets211
5Baricitinib Tablets2132
6注射用头孢唑肟钠 · No verified English name214
7Minocycline Hydrochloride Capsules2119
8Esmolol Hydrochloride and Sodium Chloride Injection210
9Sitagliptin Phosphate Tablets212
10Roxadustat Capsules2117

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

173 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Hua Feng Pharmaceutical Co., Ltd. romanized990
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized840
3CHEPLAPHARM Registration GmbH720
4Qin Huang Dao Shan Hai Guan Pharma Co., Ltd. romanized660
5Eli Lilly and Company610
6Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized610
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
8AbbVie Inc.420
9Fresenius Kabi Austria GmbH410
10Shandong Bo An Bio Technology 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

91 this week

AcceptedDrugApplicants
2024/05/29Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2401606 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/05/29Generic · Class 3 Chlorphenamine Maleate InjectionCYHS2401605 Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized
2024/05/29Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2401603 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2024/05/29New drug · Class 3.1 玉女煎颗粒 · No verified English nameCXZS2400018 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/05/29New drug · Class 1 SGC001注射液 · No verified English nameCXSL2400352 Beijing Shun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/29New drug · Class 1 注射用ZG005 · No verified English nameCXSL2400351 Name not romanized
2024/05/29New drug · Class 1 HRS-1167片 · No verified English nameCXHL2400544 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/29New drug · Class 1 HRS-1167片 · No verified English nameCXHL2400543 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/29New drug · Class 1 HRS-1167片 · No verified English nameCXHL2400542 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/29New drug · Class 1 SHR2554片 · No verified English nameCXHL2400541 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/29New drug · Class 1 SHR7280片 · No verified English nameCXHL2400540 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/29New drug · Class 1 SHR7280片 · No verified English nameCXHL2400539 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/29New drug · Class 1 HRS-5041片 · No verified English nameCXHL2400538 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/05/29New drug · Class 1 HRS-5041片 · No verified English nameCXHL2400537 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/05/29New drug · Class 1 BN104片 · No verified English nameCXHL2400536 Ye Hui Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/05/29New drug · Class 1 BN104片 · No verified English nameCXHL2400535 Ye Hui Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/05/29New drug · Class 1 HX301胶囊 · No verified English nameCXHL2400534 Hangzhou Han Si Biopharmaceuticals Co., Ltd. romanized
2024/05/29New drug · Class 1 BGB-24714胶囊 · No verified English nameCXHL2400533 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/05/29New drug · Class 1 BGB-24714胶囊 · No verified English nameCXHL2400532 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/05/29New drug · Class 1 BGB-24714胶囊 · No verified English nameCXHL2400531 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/05/29New drug · Class 1 TQB3702片 · No verified English nameCXHL2400530 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/05/29New drug · Class 1 HSK44459片 · No verified English nameCXHL2400529 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/05/29New drug · Class 1 HSK44459片 · No verified English nameCXHL2400528 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/05/28Import · Class 2.2 贝利尤单抗注射液(皮下注射) · No verified English nameJXSL2400104 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400123 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400122 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400121 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400120 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400119 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2400118 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

61 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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