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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 386 drug applications between 4 August 2025 and 10 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 82 drug names.

2025/08/04 – 2025/08/10

Period
2025/08/04 to 2025/08/10, 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
386
Drugs with new generic filings (by drug name, de-duplicated)
82
Accepted this week, now under review
107

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

386filings, 111 of them generic

By application type

Application typeFilings
Supplement166
Generic111
New drug78
Import re-registration15
Import13
Unspecified3

By drug type

Drug typeFilings
Chemical drug234
TCM85
Therapeutic biologic65
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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1替尔泊肽注射液 · No verified English name4122
2Finerenone Tablets3269
3中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
4Levetiracetam Tablets316
5Acetylcysteine Injection2253
6Lactulose Oral Solution2134
7Tacrolimus Ointment216
8Piracetam Injection219
9Procaterol Hydrochloride Solution for Inhalation212
10Cefditoren Pivoxil Granules2118

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

221 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shen Yao He Ze Pharma (Shandong) Co., Ltd. romanized1560
2Shanxi Hua Kang Pharma Co., Ltd. romanized980
3Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized980
4Hunan Ke Lun Pharmaceutical Co., Ltd. romanized866
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized750
6Bayer Inc.610
7Guizhou Hao Cheng Pharma Co., Ltd. romanized550
8Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized550
9Hua Run Zi Zhu Pharma Co., Ltd. romanized542
10Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized540

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

130 this week

AcceptedDrugApplicants
2025/08/09Generic · Class 3 Glycopyrrolate InjectionCYHS2502894 Henan Pu Rui Pharma Co., Ltd. romanized
2025/08/09Generic · Class 3 Glycopyrrolate InjectionCYHS2502893 Henan Pu Rui Pharma Co., Ltd. romanized
2025/08/09Generic · Class 3 Elagolix Sodium TabletsCYHS2502892 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/08/09Generic · Class 3 Elagolix Sodium TabletsCYHS2502891 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/08/09Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2502890 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2025/08/09Generic · Class 3 Colistimethate Sodium for InjectionCYHL2500139 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2025/08/09Generic · Class 3 Pregabalin Extended release TabletsCYHL2500138 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/08/09Generic · Class 3 Pregabalin Extended release TabletsCYHL2500137 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/08/09New drug · Class 3.3 西妥昔单抗注射液 · No verified English nameCXSS2500081 Guangdong An Pu Ze Biopharmaceuticals Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized
2025/08/09New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2500080 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2025/08/09New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2500079 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2025/08/09New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2500689 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2500688 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 注射用FH-006 · No verified English nameCXSL2500687 Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2500686 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 注射用SHR-9839 (sc) · No verified English nameCXSL2500685 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2500684 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2500683 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2500682 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500681 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 注射用BL-M24D1 · No verified English nameCXSL2500680 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/08/09New drug · Class 1 QX029N注射液 · No verified English nameCXSL2500679 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/08/09New drug · Class 1 HRS-7058片 · No verified English nameCXHL2500832 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 HRS-7058片 · No verified English nameCXHL2500831 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 HRS-7058胶囊 · No verified English nameCXHL2500830 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 HRS-7058胶囊 · No verified English nameCXHL2500829 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 2.4 苹果酸法米替尼胶囊 · No verified English nameCXHL2500828 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 HRS-4642注射液 · No verified English nameCXHL2500827 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 HRS-4642注射液 · No verified English nameCXHL2500826 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/09New drug · Class 1 TQB3122胶囊 · No verified English nameCXHL2500825 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD

100 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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