YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 414 drug applications between 28 August 2026 and 3 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 44 drug names.
2026/08/28 – 2026/09/03
- New acceptances this week
- 414
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- Accepted this week, now under review
- 304
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
414filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 234 |
| New drug | 73 |
| Generic | 58 |
| Import | 38 |
| Import re-registration | 9 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| TCM | 140 |
| Therapeutic biologic | 79 |
| Prophylactic biologic | 4 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 二硫化硒洗剂 · No verified English name | 3 | 2 | 14 |
| 2 | Rotigotine Patches | 3 | 1 | 7 |
| 3 | Lactulose Oral Solution | 2 | 1 | 34 |
| 4 | Eplerenone Tablets | 2 | 1 | 4 |
| 5 | Empagliflozin Tablets | 2 | 1 | 18 |
| 6 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 7 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 8 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 1 | 20 |
| 9 | Minoxidil Liniment | 2 | 1 | 52 |
| 10 | Ferric Carboxymaltose Injection | 2 | 1 | 10 |
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
235 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AbbVie Inc. | 9 | 2 | 0 |
| 2 | Gan Li Pharma Shandong Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Changchun Jin Sai Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 4 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Novartis Pharma AG | 6 | 4 | 0 |
| 6 | Pfizer Inc. | 6 | 4 | 0 |
| 7 | F. Hoffmann-La Roche Ltd | 6 | 1 | 0 |
| 8 | Beijing Kang Di Ni Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Novo Nordisk A/S | 5 | 1 | 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
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/03Import · Class 1 | 伐米奇拜单抗注射液 · No verified English nameJXSS2600089 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2026/09/03Import · Class 3.1 | 西妥昔单抗注射液 · No verified English nameJXSS2600088 | Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd. |
| 2026/09/03Import · Class 1 | Budoprutug注射液 · No verified English nameJXSL2600236 | Climb Bio Inc.; Beijing Mabworks Biotech Company Limited |
| 2026/09/03Import · Class 1 | EDK060 · No verified English nameJXHL2600393 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/09/03Import · Class 1 | verducatib 片 · No verified English nameJXHL2600392 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/09/03Generic · Class 3 | Eltrombopag Lamine For Oral SuspensionCYHS2602204 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/09/03Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2602201 | Hebei Yi Pin Pharmaceutical Co., Ltd. romanized |
| 2026/09/03Generic · Class 3 | Minoxidil LinimentCYHS2602200 | Jiangsu Peng Yao Pharma Co., Ltd. romanized |
| 2026/09/03Generic · Class 3 | Minoxidil LinimentCYHS2602199 | Jiangsu Peng Yao Pharma Co., Ltd. romanized |
| 2026/09/03Generic · Class 3 | Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2602196 | Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized |
| 2026/09/03New drug · Class 1.2 | RBC067提取物 · No verified English nameCXZL2600086 | Sen Rui Pu Sheng Ming Ke Xue Pharma (Hainan) Group Co., Ltd. romanized |
| 2026/09/03New drug · Class 1.2 | RBC067凝胶 · No verified English nameCXZL2600085 | Sen Rui Pu Sheng Ming Ke Xue Pharma (Hainan) Group Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | BNT3219注射液 · No verified English nameCXSL2600958 | Bai Ou En Tai (Zhuhai) Pharmaceuticals Research and Development Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2600957 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | QLS2416注射液 · No verified English nameCXSL2600956 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | 注射用HS-20110 · No verified English nameCXSL2600955 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | ICP-B161注射液 · No verified English nameCXSL2600954 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | HRS-7535片 · No verified English nameCXHS2600125 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | HRS-7535片 · No verified English nameCXHS2600124 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | 注射用RYUC-L-18 · No verified English nameCXHL2601070 | Rui Yang (Shanghai) Xin Yao Research and Development Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | 注射用RYUC-L-18 · No verified English nameCXHL2601069 | Rui Yang (Shanghai) Xin Yao Research and Development Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | KVC-191喷雾剂 · No verified English nameCXHL2601068 | Ke Wei Xi (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/09/03New drug · Class 1 | KVC-191喷雾剂 · No verified English nameCXHL2601067 | Ke Wei Xi (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/09/03New drug · Class 2.2 | 布瑞哌唑口服溶液 · No verified English nameCXHL2601066 | Lu Zhou Shi Ren Xin Pharma Co., Ltd. romanized |
| 2026/09/02Import · Class 3.1 | 莫妥珠单抗注射液(皮下注射) · No verified English nameJXSS2600087 | Roche Registration GmbH; Genentech Inc.; Roche (China) Holding Ltd. |
| 2026/09/02Import · Class 3.1 | 莫妥珠单抗注射液(皮下注射) · No verified English nameJXSS2600086 | Roche Registration GmbH; Genentech Inc.; Roche (China) Holding Ltd. |
| 2026/09/02Import · Class 3.4 | 注射用A型肉毒毒素 · No verified English nameJXSS2600085 | CKD Bio Corporation |
| 2026/09/02Import · Class 1 | ABBV-295注射液 · No verified English nameJXHL2600391 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd |
| 2026/09/02Import · Class 1 | ABBV-295注射液 · No verified English nameJXHL2600390 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd |
| 2026/09/02Import · Class 1 | ABBV-295注射液 · No verified English nameJXHL2600389 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd |
98 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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