YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 498 drug applications between 8 August 2026 and 14 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 61 drug names.
2026/08/08 – 2026/08/14
- New acceptances this week
- 498
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 260
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
498filings, 87 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 296 |
| Generic | 87 |
| New drug | 64 |
| Import | 37 |
| Import re-registration | 8 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 244 |
| TCM | 181 |
| Therapeutic biologic | 66 |
| Prophylactic biologic | 5 |
| Biologic | 2 |
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
61 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 | 4 | 3 | 22 |
| 2 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 3 | 2 | 45 |
| 4 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 5 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 6 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 7 | Lactulose Oral Solution | 2 | 2 | 34 |
| 8 | 盐酸阿莫罗芬搽剂 · No verified English name | 2 | 2 | 15 |
| 9 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 10 | Iron Proteinsuccinylate Oral Solution | 2 | 2 | 26 |
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 | F. Hoffmann-La Roche Ltd | 12 | 2 | 0 |
| 2 | Jilin Gao Miao Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | AstraZeneca AB | 8 | 5 | 0 |
| 4 | Guangdong Tai En Kang Pharmaceutical Factory Co., Ltd. romanized | 8 | 3 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 8 | 3 | 0 |
| 6 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 7 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 7 | 6 | 0 |
| 8 | Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized | 7 | 5 | 0 |
| 9 | Novo Nordisk A/S | 7 | 1 | 0 |
| 10 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 6 | 3 | 4 |
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 |
|---|---|---|
| 2026/08/14Import · 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. |
| 2026/08/14Import · Class 1 | RO7795068注射液 · No verified English nameJXHL2600340 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/14Import · Class 1 | LY4257496注射液 · No verified English nameJXHL2600339 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/08/14Import · Class 2.4 | Rilzabrutinib片 · No verified English nameJXHL2600338 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/08/14Import · Class 2.2; 2.4 | Rilzabrutinib微片 · No verified English nameJXHL2600337 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/08/14Generic · Class 3 | 米诺地尔泡沫剂 · No verified English nameCYHS2602020 | Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2026/08/14Generic · Class 3 | Pregabalin Extended release TabletsCYHS2602018 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/08/14Generic · Class 3 | Pregabalin Extended release TabletsCYHS2602017 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/08/14Generic · Class 3 | Pregabalin Extended release TabletsCYHS2602016 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/08/14Generic · Class 3 | 盐酸精氨酸注射液 · No verified English nameCYHS2602012 | Tian Sheng Pharmaceutical Group Co., Ltd. romanized |
| 2026/08/14Generic · Class 3 | 中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHS2602011 | Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized; Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2026/08/14New drug · Class 1.1 | 皮炎消颗粒 · No verified English nameCXZL2600076 | Shanxi Xin Zhou Xing Hua Pi Fu Bing Zhuan Ke Hospital romanized |
| 2026/08/14New drug · Class 2.2 | 吸附无细胞百(五组分)白破联合疫苗 · No verified English nameCXSS2600123 | Kang Xi Nuo Bio Shareholding Company romanized |
| 2026/08/14New drug · Class 1 | 注射用SHR-9839(sc) · No verified English nameCXSL2600869 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/08/14New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600868 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | 注射用MHB034C · No verified English nameCXSL2600867 | Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2600866 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | 注射用RT036 · No verified English nameCXSL2600865 | Shanghai Ruo Tuo Bio Technology Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | GC012F注射液 · No verified English nameCXSL2600864 | Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized; A Si Li Kang Investment (Zhongguo) Co., Ltd. romanized; Suzhou Gen Xi Bio Technology Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601007 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601006 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601005 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601004 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2601003 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2601002 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/08/14New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2601001 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
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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