YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 504 drug applications between 11 August 2026 and 17 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 57 drug names.
2026/08/11 – 2026/08/17
- New acceptances this week
- 504
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 238
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
504filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 309 |
| Generic | 77 |
| New drug | 67 |
| Import | 40 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 251 |
| TCM | 165 |
| Therapeutic biologic | 80 |
| Prophylactic biologic | 5 |
| 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 3 | 2 | 22 |
| 2 | 苯磺酸左氨氯地平片 · No verified English name | 3 | 2 | 45 |
| 3 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | 醋酸地非法林注射液 · No verified English name | 2 | 2 | 8 |
| 8 | Sodium Ibandronate Injection | 2 | 1 | 4 |
| 9 | Levofloxacin Eye Drops | 2 | 1 | 16 |
| 10 | Caspofungin Acetate for Injection | 2 | 1 | 8 |
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
278 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 14 | 1 | 0 |
| 2 | F. Hoffmann-La Roche Ltd | 13 | 3 | 0 |
| 3 | Jilin Gao Miao Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 9 | 3 | 0 |
| 5 | AstraZeneca AB | 8 | 5 | 0 |
| 6 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 8 | 4 | 4 |
| 7 | Guangdong Tai En Kang Pharmaceutical Factory Co., Ltd. romanized | 8 | 3 | 0 |
| 8 | Novo Nordisk A/S | 8 | 2 | 0 |
| 9 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 10 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 7 | 7 | 2 |
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
134 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/17Import · Class 1 | VAY736注射液 · No verified English nameJXSL2600208 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/08/17Import · Class 1 | ALPN-303注射液 · No verified English nameJXSL2600207 | Vertex Pharmaceuticals Incorporated; Name not romanized |
| 2026/08/17Import · Class 1 | CDR132L注射液 · No verified English nameJXHL2600346 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/17Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2602035 | Sichuan Qun Le Kang Pharma Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized |
| 2026/08/17Generic · Class 3 | 螺内酯片 · No verified English nameCYHS2602033 | Jin Wei Shi (Tianjin) Technology Co., Ltd. romanized; TIANJIN LISHENG PHARMACEUTICAL CO., LTD |
| 2026/08/17Generic · Class 3 | 螺内酯片 · No verified English nameCYHS2602032 | Jin Wei Shi (Tianjin) Technology Co., Ltd. romanized; TIANJIN LISHENG PHARMACEUTICAL CO., LTD |
| 2026/08/17Generic · Class 3 | Cetirizine Hydrochloride InjectionCYHS2602030 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized |
| 2026/08/17Generic · Class 3 | Bilastine Orally disintegrating TabletsCYHS2602029 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized |
| 2026/08/17Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2602027 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2026/08/17Generic · Class 3 | Indobufen TabletsCYHS2602023 | Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2026/08/17New drug · Class 1.1 | 天葛定眩颗粒 · No verified English nameCXZL2600077 | Sichuan Guang Da Pharmaceutical Co., Ltd. romanized |
| 2026/08/17New drug · Class 2.2 | 安尼妥单抗注射液 · No verified English nameCXSS2600126 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized; Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2026/08/17New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600125 | Zhi Tai Pharma (Tai Zhou) Co., Ltd. romanized |
| 2026/08/17New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600124 | Zhi Tai Pharma (Tai Zhou) Co., Ltd. romanized |
| 2026/08/17New drug · Class 1 | SHR-1139注射液 · No verified English nameCXSL2600876 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/17New drug · Class 2.4 | 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600875 | Suzhou Ruo Yi Bio Technology Co., Ltd. romanized |
| 2026/08/17New drug · Class 1 | SZ1003注射液 · No verified English nameCXSL2600874 | Guangdong Pu Luo Kai Rong Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/17New drug · Class 2.2 | 艾米迈托赛注射液 · No verified English nameCXSL2600873 | Bo Sheng Zhuo Yue Bio Technology (Beijing) Co., Ltd. romanized |
| 2026/08/17New drug · Class 1 | 注射用Efimosfermin alfa · No verified English nameCXSL2600872 | Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized |
| 2026/08/17New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2600871 | Changchun Tuo Hua Pharmaceuticals Co., Ltd. romanized |
| 2026/08/17New drug · Class 1 | 注射用GenSci136 · No verified English nameCXSL2600870 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/08/17New drug · Class 2.2 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHS2600118 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2026/08/17New drug · Class 1 | SIM0518胶囊 · No verified English nameCXHL2601010 | Shanghai Xian Sheng Zai Ming Technology Co., Ltd. romanized |
| 2026/08/17New drug · Class 1 | SIM0518胶囊 · No verified English nameCXHL2601009 | Shanghai Xian Sheng Zai Ming Technology Co., Ltd. romanized |
| 2026/08/17New drug · Class 1 | 68Ga-NRT6020注射液 · No verified English nameCXHL2601008 | Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized |
| 2026/08/14Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600345 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/14Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600344 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/14Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600343 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/14Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600342 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/14Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600341 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
104 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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