YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 493 drug applications between 24 September 2025 and 30 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 73 drug names.

2025/09/24 – 2025/09/30

Period
2025/09/24 to 2025/09/30, 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
493
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
111

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

493filings, 93 of them generic

By application type

Application typeFilings
Supplement254
Generic93
New drug92
Import29
Import re-registration15
Unspecified10

By drug type

Drug typeFilings
Chemical drug283
TCM114
Therapeutic biologic89
Prophylactic biologic4
Unspecified2
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

73 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets3170
2Ezetimibe and Atorvastatin Calcium Tablets(II)229
3Glucosamine Sulfate Capsules2251
4蒙脱石混悬液 · No verified English name2231
5Acetylcysteine Granules214
6Tacrolimus Ointment216
7Carboplatin Injection2110
8Cefditoren Pivoxil Granules2118
9布比卡因脂质体注射液 · No verified English name217
10Bumetanide Injection2113

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

293 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Ke Lun Pharma Co., Ltd. romanized1520
2Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized13130
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized1180
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized760
5AstraZeneca AB750
6Otsuka Pharmaceutical Co.,Ltd.610
7Jilin Sheng Qi Ke Pharma Co., Ltd. romanized530
8Shandong Qidu Pharmaceutical Co., Ltd.522
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
10Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized510

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

138 this week

AcceptedDrugApplicants
2025/09/30Import · Class 1 MK-1084片 · No verified English nameJXHL2500304 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/09/30Import · Class 1 MK-1084片 · No verified English nameJXHL2500303 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/09/30Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2503584 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2025/09/30Generic · Class 3 Bumetanide InjectionCYHS2503579 Shandong Yi Jian Pharma Co., Ltd. romanized
2025/09/30Generic · Class 3 Bumetanide InjectionCYHS2503578 Shandong Yi Jian Pharma Co., Ltd. romanized
2025/09/30New drug · Class 1.1 精芪化浊颗粒 · No verified English nameCXZL2500091 Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized
2025/09/30New drug · Class 3.2 尼妥珠单抗注射液 · No verified English nameCXSS2500105 Bai Tai Bio Pharma Co., Ltd. romanized
2025/09/30New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSS2500104 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/09/30New drug · Class 1 伊立芙普α眼内注射液 · No verified English nameCXSS2500103 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/09/30New drug · Class 1 HY001N细胞注射液 · No verified English nameCXSL2500854 He Yuan Bio Technology (Tianjin) Co., Ltd. romanized; Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized
2025/09/30New drug · Class 1 注射用TQB2102 · No verified English nameCXSL2500853 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/09/30New drug · Class 1 注射用BG-C137 · No verified English nameCXSL2500852 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/09/30New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2500851 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/09/30New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2500850 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/09/30New drug · Class 2.4 苹果酸法米替尼胶囊 · No verified English nameCXHS2500122 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/30New drug · Class 2.4 GEN-725片 · No verified English nameCXHL2501058 Henan Zhen Shi Bio Technology Co., Ltd. romanized
2025/09/30New drug · Class 2.4 GEN-725片 · No verified English nameCXHL2501057 Henan Zhen Shi Bio Technology Co., Ltd. romanized
2025/09/29Import · Class 1 注射用MK-2400 · No verified English nameJXSL2500192 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/09/29Import · Class 1 注射用MK-6070 · No verified English nameJXSL2500191 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/09/29Import · Class 1 NNC6019-0001注射液 · No verified English nameJXSL2500190 Novo Nordisk A/S; ICON Clinical Research (Beijing No. 2) Co. Ltd.
2025/09/29Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2503587 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/09/29Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2503586 Qilu Pharmaceutical (Hainan) Co., Ltd
2025/09/29Generic · Class 3 Furosemide TabletsCYHS2503564 Hai Hong Heng Long (Hainan) Bio Technology Co., Ltd. romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized
2025/09/29Generic · Class 3 Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2500175 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2025/09/29New drug · Class 3.1 泻白散颗粒 · No verified English nameCXZS2500043 Xi Shi Lan (Nan Yang) Pharma Co., Ltd. romanized; Mian Yang Yi Kang Pharmaceutical Co., Ltd. romanized
2025/09/29New drug · Class 1.1 金防风袋泡茶 · No verified English nameCXZL2500090 Jiangxi Shou Zheng Pharma Co., Ltd. romanized
2025/09/29New drug · Class 1 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSS2500102 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized; Beijing Hua Fang Tian Shi Biopharmaceutical Co., Ltd. romanized
2025/09/29New drug · Class 3.3 GLR1044注射液 · No verified English nameCXSL2500849 Gan Li Pharma Shandong Co., Ltd. romanized
2025/09/29New drug · Class 1 注射用SHR-9839(sc) · No verified English nameCXSL2500848 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/29New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500847 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized

108 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.