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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 557 drug applications between 14 September 2026 and 20 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 62 drug names.

2026/09/14 – 2026/09/20

Period
2026/09/14 to 2026/09/20, 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
557
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
481

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

557filings, 89 of them generic

By application type

Application typeFilings
Supplement289
New drug128
Generic89
Import31
Unspecified10
Import re-registration10

By drug type

Drug typeFilings
Chemical drug269
TCM176
Therapeutic biologic106
Biologic4
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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets4127
2Emedastine Difumarate Sustained-release Capsules3211
3司美格鲁肽注射液 · No verified English name3192
4盐酸金刚烷胺口服溶液 · No verified English name313
5Oseltamivir Phosphate Capsules3139
6Polidocanol Injection3123
7Mupirocin Ointment3130
8Fruquintinib Capsules214
9Tranexamic Acid Injection2111
10Sacubitril Valsartan Sodium Tablets2170

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

313 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized1180
2Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized960
3Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized870
4Janssen-Cilag International NV810
5Novartis Pharma AG740
6F. Hoffmann-La Roche Ltd720
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
8Novo Nordisk A/S620
9Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized620
10Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized620

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

182 this week

AcceptedDrugApplicants
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
2026/09/20Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2602345 Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2026/09/20Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2602343 Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized
2026/09/20Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2602342 Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized
2026/09/20New drug · Class 3.1 二冬汤颗粒 · No verified English nameCXZS2600051 Shandong Zhong Tai Pharma Co., Ltd. romanized
2026/09/20New drug · Class 1.1 芪翘清瘟解毒颗粒 · No verified English nameCXZL2600092 Beijing Kui Zheng Zhong Pharmaceuticals Technology Co., Ltd. romanized
2026/09/20New drug · Class 1.1 芎芷祛风止痛颗粒 · No verified English nameCXZL2600091 Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized
2026/09/20New drug · Class 1 IBI3002 · No verified English nameCXSL2601037 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/09/20New drug · Class 1 JMB2403注射液 · No verified English nameCXSL2601036 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized; Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2026/09/20New drug · Class 1 SYS6069 · No verified English nameCXSL2601035 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/09/20New drug · Class 2.1; 2.2 人碱性成纤维细胞生长因子滴眼液 · No verified English nameCXSL2601034 Lang Tai Biopharmaceutical Co., Ltd. romanized
2026/09/20New drug · Class 2.1; 2.2 人碱性成纤维细胞生长因子滴眼液 · No verified English nameCXSL2601033 Lang Tai Biopharmaceutical Co., Ltd. romanized
2026/09/20New drug · Class 2.1; 2.2 人碱性成纤维细胞生长因子滴眼液 · No verified English nameCXSL2601032 Lang Tai Biopharmaceutical Co., Ltd. romanized
2026/09/20New drug · Class 1 血浆生物净化柱 · No verified English nameCXSL2601031 Shanghai Wei Zhi Zhuo Bio Technology Co., Ltd. romanized; Wei Zhi Zhuo Bio Technology (Chengdu) Co., Ltd. romanized
2026/09/20New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2601030 Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized
2026/09/20New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSL2601029 Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized
2026/09/20New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHS2600135 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Li Si Biopharmaceuticals Co., Ltd. romanized
2026/09/20New drug · Class 1 GLR2053片 · No verified English nameCXHL2601184 Gan Li Pharma Co., Ltd. romanized

152 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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