YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 442 drug applications between 6 August 2026 and 12 August 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 78, covering 58 drug names.
2026/08/06 – 2026/08/12
- New acceptances this week
- 442
- Drugs with new generic filings (by drug name, de-duplicated)
- 58
- Accepted this week, now under review
- 226
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
442filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 258 |
| Generic | 78 |
| New drug | 60 |
| Import | 32 |
| Unspecified | 7 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 212 |
| TCM | 157 |
| Therapeutic biologic | 67 |
| Prophylactic biologic | 4 |
| 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
58 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 替尔泊肽注射液 · No verified English name | 4 | 1 | 22 |
| 2 | Mirogabalin Besilate Tablets | 3 | 2 | 61 |
| 3 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 4 | 鱼油(3%)橄榄油中/长链脂肪乳/氨基酸(16)/葡萄糖(13%)注射液 · No verified English name | 3 | 1 | 6 |
| 5 | Upadacitinib Sustained-release Tablets | 2 | 2 | 40 |
| 6 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 2 | 17 |
| 7 | Sodium Ibandronate Injection | 2 | 1 | 4 |
| 8 | Cyclophosphamide for Injection | 2 | 1 | 3 |
| 9 | Tetracaine Hydrochloride Gel | 2 | 1 | 5 |
| 10 | 盐酸西替利嗪滴剂 · No verified English name | 2 | 1 | 7 |
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
267 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Topfond Pharmaceutical Co., Ltd. | 8 | 7 | 0 |
| 2 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized | 7 | 5 | 0 |
| 4 | Novo Nordisk A/S | 7 | 1 | 0 |
| 5 | Bayer Inc. | 6 | 1 | 0 |
| 6 | F. Hoffmann-La Roche Ltd | 6 | 1 | 0 |
| 7 | Gilead Sciences Inc. | 6 | 1 | 0 |
| 8 | AstraZeneca AB | 5 | 3 | 0 |
| 9 | GlaxoSmithKline Trading Services Limited | 5 | 2 | 0 |
| 10 | Heng Yi Biopharmaceuticals (Jiangsu) Co., Ltd. romanized | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600206 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600205 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600204 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600203 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600202 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600201 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600200 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/12Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600199 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/12Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600198 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/12Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600197 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/12Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600196 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/12Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600195 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/12Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600194 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/12Import · Class 1 | Verve-102注射液 · No verified English nameJXSL2600193 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/08/12Import · Class 1 | ETX-636 · No verified English nameJXHL2600336 | Ensem Therapeutics Inc.; Ensem Therapeutics (Shanghai) Limited |
| 2026/08/12Import · Class 1 | ETX-636 · No verified English nameJXHL2600335 | Ensem Therapeutics Inc.; Ensem Therapeutics (Shanghai) Limited |
| 2026/08/12Generic · Class 3 | Tetracaine Hydrochloride GelCYHS2601985 | TC Pharmaceuticals (Jiangsu) Co., Ltd |
| 2026/08/12Generic · Class 3 | Tetracaine Hydrochloride GelCYHS2601984 | TC Pharmaceuticals (Jiangsu) Co., Ltd |
| 2026/08/12Generic · Class 3 | Fexofenadine Hydrochloride TabletsCYHS2601983 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2026/08/12Generic · Class 3 | Fexofenadine Hydrochloride TabletsCYHS2601982 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2026/08/12Generic · Class 3 | 硫酸锌注射液 · No verified English nameCYHS2601980 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized |
| 2026/08/12Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2601979 | Hebei Guang Xiang Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2026/08/12Generic · Class 3 | 左羟丙哌嗪口服溶液 · No verified English nameCYHS2601978 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2026/08/12Generic · Class 3 | Amoxicillin CapsulesCYHS2601976 | Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized |
| 2026/08/12Generic · Class 3 | Amoxicillin CapsulesCYHS2601975 | Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized |
| 2026/08/12Generic · Class 3 | Tebipenem Pivoxil Fine GranulesCYHL2600087 | Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/12New drug · Class 3.1 | 真武汤颗粒 · No verified English nameCXZS2600046 | Si Huan Pharmaceuticals (Zhengzhou) Co., Ltd. romanized |
| 2026/08/12New drug · Class 1.1 | 十味安肠颗粒 · No verified English nameCXZL2600075 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized; Liaoning Bei Feng Pharma Co., Ltd. romanized |
| 2026/08/12New drug · Class 1 | TJ101注射液 · No verified English nameCXSS2600122 | Tian Jing Bio Pharma (Hangzhou) Co., Ltd. romanized |
| 2026/08/12New drug · Class 1 | SKB118注射液 · No verified English nameCXSL2600856 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
86 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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