YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 492 drug applications between 17 July 2026 and 23 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 48 drug names.
2026/07/17 – 2026/07/23
- New acceptances this week
- 492
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 162
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
492filings, 71 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 308 |
| New drug | 72 |
| Generic | 71 |
| Import | 26 |
| Unspecified | 11 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| TCM | 172 |
| Therapeutic biologic | 82 |
| Prophylactic biologic | 11 |
| Biologic | 3 |
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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 5 | 2 | 55 |
| 2 | Sodium Hyaluronate Eye Drops | 4 | 2 | 30 |
| 3 | Adapalene Gel | 3 | 3 | 30 |
| 4 | Emedastine Difumarate Eye Drops | 2 | 2 | 9 |
| 5 | 布美他尼片 · No verified English name | 2 | 2 | 8 |
| 6 | Nafamostat Mesilate for Injection | 2 | 2 | 38 |
| 7 | Polyvinyl Alcohol Eye Drops | 2 | 2 | 24 |
| 8 | Gatifloxacin Eye Drops | 2 | 1 | 3 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
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
280 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 17 | 2 | 0 |
| 2 | Jiangxi Jiu Lian Shan Pharma Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Jilin Ji Er Ji Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Merck Sharp & Dohme LLC | 7 | 4 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 7 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 8 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 9 | Li Shi Zhen Pharmaceuticals Group Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 2 | 0 |
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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/23Import · Class 1 | 注射用MK-5909 · No verified English nameJXSL2600175 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/07/23Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2601774 | Sichuan Zhi Qiang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Chengdu Ping Yuan Pharma Co., Ltd. romanized |
| 2026/07/23Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601772 | Name not romanized; Jiangsu Li Tai Er Pharma Co., Ltd. romanized |
| 2026/07/23Generic · Class 3 | Ramelteon TabletsCYHL2600083 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2026/07/23New drug · Class 1.1 | CHA756丸 · No verified English nameCXZL2600065 | Nuo Bei Biopharmaceuticals Technology (Shandong) Co., Ltd. romanized |
| 2026/07/23New drug · Class 2.1; 2.2; 2.3 | 银杏二萜内酯滴丸 · No verified English nameCXZL2600064 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2026/07/23New drug · Class 2.3 | 舒筋健腰丸 · No verified English nameCXZL2600063 | Guangzhou Bai Yun Shan Chen Li Ji Pharmaceutical Factory Co., Ltd. romanized |
| 2026/07/23New drug · Class 1 | HX15001注射液 · No verified English nameCXSL2600768 | Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized |
| 2026/07/23New drug · Class 1 | HXN5003注射液 · No verified English nameCXSL2600767 | Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized |
| 2026/07/23New drug · Class 2.2 | 注射用埃普奈明 · No verified English nameCXSL2600766 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2026/07/23New drug · Class 1 | 注射用LM-364 · No verified English nameCXSL2600765 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/07/23New drug · Class 1 | 注射用GenSci136 · No verified English nameCXSL2600764 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/07/23New drug · Class 2.4 | 盐酸伊立替康脂质体注射液(Ⅱ) · No verified English nameCXHS2600106 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/07/23New drug · Class 2.4 | HS-10561胶囊 · No verified English nameCXHL2600897 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/23New drug · Class 2.2 | TH5213 · No verified English nameCXHL2600896 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2026/07/23New drug · Class 2.2 | TH5213 · No verified English nameCXHL2600895 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2026/07/22Import · Class 1 | 迪纳西米单抗注射液 · No verified English nameJXSS2600068 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d |
| 2026/07/22Import · Class 1 | 迪纳西米单抗注射液 · No verified English nameJXSS2600067 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d |
| 2026/07/22Import · Class 1 | 迪纳西米单抗注射液 · No verified English nameJXSS2600066 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d |
| 2026/07/22Import · Class 1 | 迪纳西米单抗注射液 · No verified English nameJXSS2600065 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d |
| 2026/07/22Import · Class 1 | 迪纳西米单抗注射液 · No verified English nameJXSS2600064 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d |
| 2026/07/22Import · Class 1 | NN2802 · No verified English nameJXSL2600174 | NOVELTY NOBILITY Inc.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2026/07/22Import · Class 1 | MK-1084片 · No verified English nameJXHL2600284 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/07/22Import · Class 1 | MK-1084片 · No verified English nameJXHL2600283 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/07/22Generic · Class 3 | Colistimethate Sodium for InjectionCYHS2601762 | Chengdu Ya Tu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2026/07/22Generic · Class 3 | Ferrous Succinate TabletsCYHS2601757 | Chongqing Xi Er An Pharma Co., Ltd. romanized; Chongqing Guo Tai Kang Ning Pharmaceutical Co., Ltd. romanized |
| 2026/07/22New drug · Class 1 | 注射用BL-M12D1 · No verified English nameCXSL2600763 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/07/22New drug · Class 1 | SYS6055注射液 · No verified English nameCXSL2600762 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized |
| 2026/07/22New drug · Class 1 | GZC8072片 · No verified English nameCXSL2600761 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2026/07/22New drug · Class 1 | GZC8072片 · No verified English nameCXSL2600760 | Gan Li Pharma Shandong Co., Ltd. romanized |
84 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.