YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 361 drug applications between 21 February 2026 and 27 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 63 drug names.

2026/02/21 – 2026/02/27

Period
2026/02/21 to 2026/02/27, 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
361
Drugs with new generic filings (by drug name, de-duplicated)
63
Accepted this week, now under review
130

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

361filings, 85 of them generic

By application type

Application typeFilings
Supplement150
New drug87
Generic85
Import23
Unspecified12
Import re-registration4

By drug type

Drug typeFilings
Chemical drug242
Therapeutic biologic65
TCM48
Prophylactic biologic5
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

63 drugs with new generic filings; top 10 listed

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized750
2Novartis Pharma AG730
3The Wellcome Foundation Limited720
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
5Takeda Development Center Americas Inc.620
6Luo Yang Shun Shi Pharma Co., Ltd. romanized550
7Sichuan Hao Yi Sheng Pan Xi Pharma Co., Ltd. romanized545
8Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized540
9Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized530
10Sichuan Pharmaceutical Formulations Co., Ltd. romanized520

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

144 this week

AcceptedDrugApplicants
2026/02/27Import · Class 1 ECI830 · No verified English nameJXHL2600071 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/02/27Import · Class 1 ECI830 · No verified English nameJXHL2600070 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/02/27Import · Class 1 ECI830 · No verified English nameJXHL2600069 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/02/27Import · Class 1 FWY003胶囊 · No verified English nameJXHL2600068 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/02/27Import · Class 1 FWY003胶囊 · No verified English nameJXHL2600067 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/02/27Import · Class 1 FWY003胶囊 · No verified English nameJXHL2600066 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/02/27Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2600568 Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized
2026/02/27Generic · Class 3 Nimodipine Oral SolutionCYHS2600565 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2026/02/27Generic · Class 3 Nimodipine Oral SolutionCYHS2600564 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2026/02/27Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2600563 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2026/02/27Generic · Class 3 Cariprazine hydrochloride CapsulesCYHS2600562 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2026/02/27Generic · Class 3 Cariprazine hydrochloride CapsulesCYHS2600561 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2026/02/27Generic · Class 3 Cariprazine hydrochloride CapsulesCYHS2600560 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2026/02/27Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2600559 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2026/02/27Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2600558 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Xian Yuan Da De Tian Pharma Co., Ltd. romanized
2026/02/27Generic · Class 3 Potassium Chloride GranulesCYHS2600553 Shijiazhuang Kai Sai Pharmaceuticals Technology Co., Ltd. romanized; Hua Xia Guo Yao (He Ze) Pharmaceutical Co., Ltd. romanized
2026/02/27Generic · Class 3 Eplerenone TabletsCYHL2600031 Chengdu Brilliant Pharmaceutical Co., Ltd.
2026/02/27Generic · Class 3 Eplerenone TabletsCYHL2600030 Chengdu Brilliant Pharmaceutical Co., Ltd.
2026/02/27Generic · Class 3 Neridronate Sodium InjectionCYHL2600029 Zhao Ke Pharma (Hefei) Co., Ltd. romanized
2026/02/27New drug · Class 1 注射用QLC5508 · No verified English nameCXSL2600274 Qilu Pharmaceutical Co., Ltd.
2026/02/27New drug · Class 1 HS-20117-2注射液 · No verified English nameCXSL2600267 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/02/27New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600266 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/02/27New drug · Class 1 自体天然肿瘤浸润淋巴细胞注射液 · No verified English nameCXSL2600265 Shanghai Jun Sai Bio Co., Ltd. romanized; Shanghai Jun Sai Bio Pharma Co., Ltd. romanized
2026/02/27New drug · Class 1 注射用ALK201 · No verified English nameCXSL2600264 Shanghai An Ling Ke Biopharmaceuticals Co., Ltd. romanized
2026/02/27New drug · Class 1 奥托奇拜单抗注射液 · No verified English nameCXSL2600263 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2026/02/27New drug · Class 1 TQB2868注射液 · No verified English nameCXSL2600262 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/02/27New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2600261 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/02/27New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2600260 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/02/27New drug · Class 1 注射用TQB2102 · No verified English nameCXSL2600258 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/02/27New drug · Class 1 UBT38006注射液 · No verified English nameCXSL2600257 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized

114 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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