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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 654 drug applications between 15 September 2026 and 21 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 76 drug names.

2026/09/15 – 2026/09/21

Period
2026/09/15 to 2026/09/21, 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
654
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
559

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

654filings, 105 of them generic

By application type

Application typeFilings
Supplement352
New drug137
Generic105
Import32
Unspecified14
Import re-registration14

By drug type

Drug typeFilings
Chemical drug325
TCM203
Therapeutic biologic117
Biologic7
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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets4127
2Ertugliflozin Tablets3313
3Emedastine Difumarate Sustained-release Capsules3211
4司美格鲁肽注射液 · No verified English name3192
5盐酸金刚烷胺口服溶液 · No verified English name313
6Oseltamivir Phosphate Capsules3139
7Mupirocin Ointment3130
8Glucosamine Sulfate Capsules2251
9Fruquintinib Capsules214
10Tranexamic Acid Injection2111

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

374 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1330
2Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized1180
3Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized960
4Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized870
5Janssen-Cilag International NV810
6F. Hoffmann-La Roche Ltd720
7Novo Nordisk A/S620
8Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized620
9Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized620
10Ji Chuan (Shanghai) Yi Xue Technology Co., Ltd. romanized610

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

197 this week

AcceptedDrugApplicants
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
2026/09/21New drug · Class 1 SHR-4461注射液 · No verified English nameCXSL2601040 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/09/21New drug · Class 1 BHV-1400 · No verified English nameCXSL2601039 Beijing MEDPACE Pharmaceuticals Technology Co., Ltd. romanized
2026/09/21New drug · Class 1 重组人源抗呼吸道合胞病毒单克隆抗体注射液组合制剂 · No verified English nameCXSL2601038 Changchun Bai Ke Bio Technology Shareholding Company romanized
2026/09/21New drug · Class 1 SYH2099胶囊 · No verified English nameCXHL2601187 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2026/09/21New drug · Class 1 SYH2099胶囊 · No verified English nameCXHL2601186 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2026/09/21New drug · Class 1 SYH2099胶囊 · No verified English nameCXHL2601185 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2026/09/20Import · Class 1 PF-08154225注射液 · No verified English nameJXSL2600254 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/20Import · Class 1 PF-08154225注射液 · No verified English nameJXSL2600253 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/20Import · Class 1 PF-08154225注射液 · No verified English nameJXSL2600252 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/20Import · Class 1 PF-08154225注射液 · No verified English nameJXSL2600251 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/20Import · Class 2.4 贝组替凡片 · No verified English nameJXHS2600114 MERCK SHARP & DOHME (UK) LIMITED; MSD INTERNATIONAL GMBH; MSD R&D (China) Co. Ltd
2026/09/20Import · Class 1 DDY391片 · No verified English nameJXHL2600411 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/09/20Import · Class 1 DDY391片 · No verified English nameJXHL2600410 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/09/20Generic · Class 3 恩格列净二甲双胍缓释片(Ⅳ) · No verified English nameCYHS2602355 Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized
2026/09/20Generic · Class 3 恩格列净二甲双胍缓释片(Ⅱ) · No verified English nameCYHS2602354 Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized
2026/09/20Generic · Class 3 恩格列净二甲双胍缓释片(Ⅲ) · No verified English nameCYHS2602353 Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized
2026/09/20Generic · Class 3 Hydrotalcite SuspensionCYHS2602348 Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized
2026/09/20Generic · Class 3 辅酶Q10片 · No verified English nameCYHS2602347 Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized
2026/09/20Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2602346 Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized

167 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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