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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 459 drug applications between 13 September 2026 and 19 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 49 drug names.

2026/09/13 – 2026/09/19

Period
2026/09/13 to 2026/09/19, 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
459
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
393

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

459filings, 72 of them generic

By application type

Application typeFilings
Supplement246
New drug109
Generic72
Import16
Unspecified10
Import re-registration6

By drug type

Drug typeFilings
Chemical drug221
TCM144
Therapeutic biologic88
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

49 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
10Pioglitazone Hydrochloride Tablets212

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

265 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized1070
2Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized870
3F. Hoffmann-La Roche Ltd720
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
5Novo Nordisk A/S620
6Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized620
7Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized620
8Novartis Pharma AG530
9Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized530
10Jiangxi Pin Xin Pharma Co., Ltd. romanized520

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

147 this week

AcceptedDrugApplicants
2026/09/18Import · Class 1 BMS-986446注射液 · No verified English nameJXSL2600250 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/09/18Generic · Class 3 右美沙芬缓释混悬液 · No verified English nameCYHS2602333 Anhui Yuan Wang Le Huan Pharma Co., Ltd. romanized
2026/09/18Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2602329 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2026/09/18Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2602328 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2026/09/18New drug · Class 1 注射用AK2405 · No verified English nameCXSL2601027 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2026/09/18New drug · Class 1 注射用HB0085 · No verified English nameCXSL2601026 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/09/18New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2601025 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/09/18New drug · Class 1 TQB2930注射液 · No verified English nameCXSL2601024 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/09/18New drug · Class 1 注射用MBS314 · No verified English nameCXSL2601023 Kang Yuan Bo Chuang Bio Technology (Beijing) Co., Ltd. romanized
2026/09/18New drug · Class 1 LY3839056注射液 · No verified English nameCXSL2601022 Li Lai (Zhongguo) Research and Development Co., Ltd. romanized
2026/09/18New drug · Class 1 NC001细胞注射液 · No verified English nameCXSL2601021 Zhejiang Tian Yu Sheng Ming Technology Co., Ltd. romanized
2026/09/18New drug · Class 1 ACC085片 · No verified English nameCXHL2601178 Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Lu Zhou Ai Di Pharmaceuticals Technology Co., Ltd. romanized
2026/09/18New drug · Class 1 ACC085片 · No verified English nameCXHL2601177 Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Lu Zhou Ai Di Pharmaceuticals Technology Co., Ltd. romanized
2026/09/18New drug · Class 1 FXS0260片 · No verified English nameCXHL2601176 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2026/09/18New drug · Class 1 FXS0260片 · No verified English nameCXHL2601175 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2026/09/18New drug · Class 1 FXS0260片 · No verified English nameCXHL2601174 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2026/09/18New drug · Class 1 IPG7236片 · No verified English nameCXHL2601173 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/18New drug · Class 1 IPG7236片 · No verified English nameCXHL2601172 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/18New drug · Class 1 YM-101滴眼液 · No verified English nameCXHL2601171 Name not romanized
2026/09/18New drug · Class 1 YM-101滴眼液 · No verified English nameCXHL2601170 Name not romanized
2026/09/18New drug · Class 1 YM-101滴眼液 · No verified English nameCXHL2601169 Name not romanized
2026/09/18New drug · Class 1 Y-1注射液 · No verified English nameCXHL2601168 Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized
2026/09/18New drug · Class 1 Y-1注射液 · No verified English nameCXHL2601167 Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized
2026/09/17Import · Class 1 PF-08046876 · No verified English nameJXSL2600249 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/17Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2602313 Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized
2026/09/17New drug · Class 1 IBI3043 · No verified English nameCXSL2601020 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/09/17New drug · Class 2.2 注射用波米泰酶α · No verified English nameCXSL2601019 Jiangsu Bei Jie Tai Bio Technology Co., Ltd. romanized
2026/09/17New drug · Class 1 ASP1002注射液 · No verified English nameCXSL2601018 An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized
2026/09/17New drug · Class 1 ASP1002注射液 · No verified English nameCXSL2601017 An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized
2026/09/17New drug · Class 1 注射用HX111 · No verified English nameCXSL2601016 Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized

117 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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