YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 652 drug applications between 12 October 2025 and 18 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 82 drug names.

2025/10/12 – 2025/10/18

Period
2025/10/12 to 2025/10/18, 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
652
Drugs with new generic filings (by drug name, de-duplicated)
82
Accepted this week, now under review
141

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

652filings, 111 of them generic

By application type

Application typeFilings
Supplement349
New drug126
Generic111
Unspecified34
Import27
Import re-registration5

By drug type

Drug typeFilings
Chemical drug404
TCM125
Therapeutic biologic88
Biologic24
Prophylactic biologic8
Unspecified3

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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Glucosamine Sulfate Capsules5551
2Vonoprazan Fumarate Tablets4260
3Sacubitril Valsartan Sodium Tablets3270
4甘油灌肠剂 · No verified English name312
5甲苯磺酸卢美哌隆胶囊 · No verified English name312
6LevomilnacipranHydrochloride Extended-release Capsules316
7达普司他片 · No verified English name310
8Pemafibrate Tablets2223
9磷酸奥司他韦颗粒 · No verified English name2212
10呋喃妥因胶囊 · No verified English name214

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

330 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized72520
2Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized1020
3AstraZeneca AB950
4Qilu Pharmaceutical Co., Ltd.843
5Actelion Pharmaceuticals Ltd810
6Terumo Corporation Kofu Factory810
7Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
8Zhongshan Wanhan Pharmaceuticals Co., Ltd.732
9Boehringer Ingelheim International GmbH710
10Wyeth Pharmaceutical Division of Wyeth Holdings LLC660

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
2025/10/18Import · Class 3.1 古塞奇尤单抗注射液 · No verified English nameJXSL2500206 Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.
2025/10/18Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2500205 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/10/18Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2500204 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/10/18Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2500203 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/10/18Generic · Class 3 盐酸昂丹司琼口服溶液 · No verified English nameCYHS2503739 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2025/10/18Generic · Class 3 盐酸昂丹司琼口服溶液 · No verified English nameCYHS2503738 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2025/10/18Generic · Class 3 呋喃妥因胶囊 · No verified English nameCYHS2503732 Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized
2025/10/18Generic · Class 3 呋喃妥因胶囊 · No verified English nameCYHS2503731 Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized; Shandong Yao Shi Pharma Co., Ltd. romanized
2025/10/18Generic · Class 3 Minoxidil LinimentCYHS2503730 Xiang Yu Pharma Co., Ltd. romanized
2025/10/18Generic · Class 3 Minoxidil LinimentCYHS2503729 Xiang Yu Pharma Co., Ltd. romanized
2025/10/18Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2503727 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/10/18New drug · Class 3.1 桃红四物颗粒 · No verified English nameCXZS2500045 Shanghai Kai Bao Pharma Co., Ltd. romanized
2025/10/18New drug · Class 2.3 舒肝解郁胶囊 · No verified English nameCXZS2500044 Sichuan Ji Sheng Tang Pharma Co., Ltd. romanized
2025/10/18New drug · Class 1 AVL-101 注射液 · No verified English nameCXSL2500905 Beijing An Wei Tuo Biopharmaceuticals Co., Ltd. romanized; An Wei Tuo (Gu An) Biopharmaceuticals Co., Ltd. romanized; An Wei Tuo (Yan Tai) Biopharmaceuticals Technology Co., Ltd. romanized
2025/10/18New drug · Class 2.4 Nemonoxacin Malate CapsulesCXHS2500124 Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized
2025/10/18New drug · Class 1 MY008211A片 · No verified English nameCXHS2500123 Wuhan Qi Rui Pharma Co., Ltd. romanized
2025/10/18New drug · Class 1 ICP-488片 · No verified English nameCXHL2501138 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2025/10/17Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2500202 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/10/17Generic · Class 3 Digoxin InjectionCYHS2503725 Henan Pu Rui Pharma Co., Ltd. romanized
2025/10/17Generic · Class 3 Digoxin InjectionCYHS2503724 Henan Pu Rui Pharma Co., Ltd. romanized
2025/10/17Generic · Class 3 多种微量元素注射液(Ι) · No verified English nameCYHS2503721 Wei Sheng Yuan (Xiamen) Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/10/17Generic · Class 3 醋酸锌颗粒 · No verified English nameCYHS2503719 Sichuan Kelun Pharmaceutical Co., Ltd.
2025/10/17Generic · Class 3 醋酸锌颗粒 · No verified English nameCYHS2503718 Sichuan Kelun Pharmaceutical Co., Ltd.
2025/10/17New drug · Class 2.1 TFA003片 · No verified English nameCXZL2500101 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized
2025/10/17New drug · Class 1 注射用BG-C9074 · No verified English nameCXSL2500904 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/10/17New drug · Class 1 IM19嵌合抗原受体T细胞注射液(IM19 CAR-T细胞注射液) · No verified English nameCXSL2500903 Shandong Jin Sai Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 1 INS19嵌合抗原受体T细胞注射液(INS19 CAR-T细胞注射液) · No verified English nameCXSL2500902 Shandong Jin Sai Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 1 INS19嵌合抗原受体T细胞注射液(INS19 CAR-T细胞注射液) · No verified English nameCXSL2500901 Shandong Jin Sai Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 1 MIL116注射液 · No verified English nameCXSL2500900 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 3.3 艾美赛珠单抗注射液 · No verified English nameCXSL2500899 Wuhan You Zhi You Biopharmaceutical 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.

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.