YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 406 drug applications between 26 August 2026 and 1 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 44 drug names.

2026/08/26 – 2026/09/01

Period
2026/08/26 to 2026/09/01, 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
406
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
256

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

406filings, 63 of them generic

By application type

Application typeFilings
Supplement241
Generic63
New drug61
Import33
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug191
TCM131
Therapeutic biologic76
Prophylactic biologic8

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

44 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin Tablets4284
2二硫化硒洗剂 · No verified English name3214
3Pregabalin Extended release Tablets3113
4Rotigotine Patches317
5Mupirocin Ointment2230
6Eplerenone Tablets214
7Orlistat Capsules218
8Empagliflozin Tablets2118
9Sodium Hyaluronate Eye Drops2130
10甘油灌肠剂 · No verified English name212

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Gao Miao Pharma Co., Ltd. romanized11110
2F. Hoffmann-La Roche Ltd1020
3Eli Lilly and Company930
4Novo Nordisk A/S920
5Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized740
6Novartis Pharma AG640
7Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized550
8San Men Xia Guang Yu Biopharmaceutical Co., Ltd. romanized440
9Haerbin Zhong Yao Si Factory Co., Ltd. romanized440
10Topfond Pharmaceutical Co., Ltd.440

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

115 this week

AcceptedDrugApplicants
2026/09/01Import · Class 3.4 注射用A型肉毒毒素 · No verified English nameJXSS2600084 JETEMA Co. Ltd.; Zhejiang Ningbo Zhuoyi Biotechnology Co. Ltd.
2026/09/01Import · Class 3.1 莫格利珠单抗注射液 · No verified English nameJXSS2600083 Kyowa Kirin Co. Ltd.; Otsu Pharmaceuticals Plant TOYOBO CO. LTD.
2026/09/01Import · Class 1 XEP527胶囊 · No verified English nameJXHL2600381 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2026/09/01Import · Class 1 XEP527胶囊 · No verified English nameJXHL2600380 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2026/09/01Import · Class 1 XEP527胶囊 · No verified English nameJXHL2600379 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2026/09/01Generic · Class 3 Dexketoprofen Trometamol InjectionCYHS2602182 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2026/09/01Generic · Class 3 Potassium Chloride GranulesCYHS2602172 Chongqing Xi Er An Pharma Co., Ltd. romanized; Chongqing Guo Tai Kang Ning Pharmaceutical Co., Ltd. romanized
2026/09/01Generic · Class 3 甲磺酸酚妥拉明滴眼液 · No verified English nameCYHL2600093 Hunan Mai Ou Medical Technology Co., Ltd. romanized
2026/09/01New drug · Class 2.2 安儿宁口服液 · No verified English nameCXZL2600083 Jin He Zang Yao Co., Ltd. romanized
2026/09/01New drug · Class 1.1 双枣安神颗粒 · No verified English nameCXZL2600082 Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized
2026/09/01New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSS2600133 Ai Mei Rong Yu (Ningbo) Biopharmaceutical Co., Ltd. romanized
2026/09/01New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSL2600944 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized
2026/09/01New drug · Class 1 HY8931注射液 · No verified English nameCXSL2600943 Heng Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/09/01New drug · Class 1 HY8931注射液(皮下注射) · No verified English nameCXSL2600942 Heng Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/09/01New drug · Class 1 注射用Tvac001个性化肿瘤新抗原多肽 · No verified English nameCXSL2600941 Guangzhou Run Sheng Xi Bao Pharmaceuticals Technology Co., Ltd. romanized
2026/09/01New drug · Class 1 Tvac001新抗原反应性T细胞注射液 · No verified English nameCXSL2600940 Guangzhou Run Sheng Xi Bao Pharmaceuticals Technology Co., Ltd. romanized
2026/09/01New drug · Class 1 HRS-7535片 · No verified English nameCXHS2600123 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/09/01New drug · Class 1 HRS-7535片 · No verified English nameCXHS2600122 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/09/01New drug · Class 1 RO7836748薄膜包衣片 · No verified English nameCXHL2601063 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2026/09/01New drug · Class 1 RO7836748薄膜包衣片 · No verified English nameCXHL2601062 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2026/09/01New drug · Class 1 RO7836748薄膜包衣片 · No verified English nameCXHL2601061 Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized
2026/09/01New drug · Class 1 ACT001胶囊 · No verified English nameCXHL2601060 Shang De Yao Yuan (Tianjin) Biopharmaceutical Co., Ltd. romanized
2026/09/01New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2601059 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/09/01New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2601058 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/08/31Import · Class 1 注射用MK-2750 · No verified English nameJXSL2600235 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/08/31Import · Class 1 FUB523注射液 · No verified English nameJXSL2600234 Novartis Pharma AG
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600378 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600377 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600376 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/31Import · Class 1 RO7795068注射液 · No verified English nameJXHL2600375 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.

85 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.