YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 377 drug applications between 5 August 2025 and 11 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 75 drug names.

2025/08/05 – 2025/08/11

Period
2025/08/05 to 2025/08/11, 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
377
Drugs with new generic filings (by drug name, de-duplicated)
75
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

377filings, 107 of them generic

By application type

Application typeFilings
Supplement159
Generic107
New drug77
Import16
Import re-registration15
Unspecified3

By drug type

Drug typeFilings
Chemical drug234
TCM78
Therapeutic biologic63
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

75 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets4270
2替尔泊肽注射液 · No verified English name4122
3Acetylcysteine Injection3353
4Finerenone Tablets3269
5中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
6Levetiracetam Tablets316
7Lactulose Oral Solution2134
8Tacrolimus Ointment216
9Piracetam Injection219
10Procaterol Hydrochloride Solution for Inhalation212

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

210 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shen Yao He Ze Pharma (Shandong) Co., Ltd. romanized1560
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1060
3Shanxi Hua Kang Pharma Co., Ltd. romanized980
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized980
5Hunan Ke Lun Pharmaceutical Co., Ltd. romanized756
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

126 this week

AcceptedDrugApplicants
2025/08/11Import · Class 1 Icotrokinra片 · No verified English nameJXHL2500213 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/08/11Import · Class 2.4; 2.2 马立巴韦干混悬剂 · No verified English nameJXHL2500212 Takeda Pharmaceuticals U.S.A. Inc; Takeda(China) International Company Ltd.
2025/08/11Import · Class 2.4; 2.2 马立巴韦干混悬剂 · No verified English nameJXHL2500211 Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International Company Ltd.
2025/08/11New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHS2500094 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/11New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHS2500093 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/11New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHS2500092 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
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

96 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.