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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 647 drug applications between 16 September 2026 and 22 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 100, covering 68 drug names.

2026/09/16 – 2026/09/22

Period
2026/09/16 to 2026/09/22, 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
647
Drugs with new generic filings (by drug name, de-duplicated)
68
Accepted this week, now under review
535

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

647filings, 100 of them generic

By application type

Application typeFilings
Supplement359
New drug121
Generic100
Import29
Import re-registration20
Unspecified18

By drug type

Drug typeFilings
Chemical drug320
TCM196
Therapeutic biologic119
Biologic11
Prophylactic 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

68 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

363 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1330
2Janssen-Cilag International NV1030
3Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized920
4Bayer Vital GmbH910
5Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized870
6Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized810
7Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized750
8Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized720
9Jiangsu Lian Huan Zhong Yao Co., Ltd. romanized640
10Novo Nordisk A/S620

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

169 this week

AcceptedDrugApplicants
2026/09/22Import · Class 1 MK-7240注射液 · No verified English nameJXSL2600256 Merck Sharp & Dohme LLC; Name not romanized
2026/09/22Generic · Class 3 盐酸西替利嗪滴眼液 · No verified English nameCYHS2602384 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jiangxi Ke Lun Pharma Co., Ltd. romanized
2026/09/22Generic · Class 3 地塞米松口服溶液 · No verified English nameCYHS2602383 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized
2026/09/22Generic · Class 3 Brimonidine Tartrate Eye DropsCYHL2600102 Da Bang (Hunan) Biopharmaceutical Co., Ltd. romanized
2026/09/22New drug · Class 1.1 HG1101颗粒 · No verified English nameCXZL2600093 He Guang Zhong Yao Technology (Tianjin) Co., Ltd. romanized
2026/09/22New drug · Class 3.3 注射用曲妥珠单抗 · No verified English nameCXSS2600153 Hua Lan An Kang Bio Co., Ltd. romanized
2026/09/22New drug · Class 1 9MW5211注射液 · No verified English nameCXSL2601051 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/09/22New drug · Class 1 N69胶囊 · No verified English nameCXSL2601050 Shanghai De Jian Cong He Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/22New drug · Class 3.2 人C1酯酶抑制剂 · No verified English nameCXSL2601049 Guo Yao Group Wuhan Biopharmaceutical Co., Ltd. romanized
2026/09/22New drug · Class 1 注射用DB-1323 · No verified English nameCXSL2601048 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/09/22New drug · Class 1 注射用BG-C477 · No verified English nameCXSL2601047 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/09/22New drug · Class 2.2 斯鲁利单抗注射液 · No verified English nameCXSL2601046 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized
2026/09/22New drug · Class 1 NTS231片 · No verified English nameCXHL2601194 Shanghai Yu Dao Bio Technology Co., Ltd. romanized
2026/09/22New drug · Class 1 NTS231片 · No verified English nameCXHL2601193 Shanghai Yu Dao Bio Technology Co., Ltd. romanized
2026/09/22New drug · Class 1 K-119肠溶片 · No verified English nameCXHL2601192 Shanghai Rui Le Jin Bio Technology Co., Ltd. romanized
2026/09/22New drug · Class 1 K-119肠溶片 · No verified English nameCXHL2601191 Shanghai Rui Le Jin Bio Technology Co., Ltd. romanized
2026/09/22New drug · Class 1 JCSH-021片 · No verified English nameCXHL2601190 Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized
2026/09/22New drug · Class 1 JCSH-021片 · No verified English nameCXHL2601189 Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized
2026/09/22New drug · Class 1 JCSH-021片 · No verified English nameCXHL2601188 Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized
2026/09/21Import · Class 1 SAR448632注射用粉末 · No verified English nameJXSL2600255 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/09/21Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2602374 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/09/21Generic · Class 3 盐酸西替利嗪滴眼液 · No verified English nameCYHS2602367 Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized
2026/09/21Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2602365 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2026/09/21Generic · Class 3 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2602359 Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized
2026/09/21Generic · Class 3 Trelagliptin Succinate TabletsCYHS2602358 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2026/09/21New drug · Class 1 YT003注射液 · No verified English nameCXSL2601045 Beijing Yong Tai Bio Zhi Pin Co., Ltd. romanized
2026/09/21New drug · Class 1 BT02单克隆抗体注射液 · No verified English nameCXSL2601044 Shanghai Bai Quan Bio Technology Co., Ltd. romanized
2026/09/21New drug · Class 1 HS-IT101注射液 · No verified English nameCXSL2601043 Qingdao Zhong Sai Bo Man Bio Technology Co., Ltd. romanized
2026/09/21New drug · Class 1 注射用TQB6411 · No verified English nameCXSL2601042 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/09/21New drug · Class 1 SHR-4506注射液 · No verified English nameCXSL2601041 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized

139 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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