YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 235 drug applications between 30 June 2021 and 6 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 23 drug names.
2021/06/30 – 2021/07/06
- New acceptances this week
- 235
- Drugs with new generic filings (by drug name, de-duplicated)
- 23
- Accepted this week, now under review
- 0
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
235filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 125 |
| Generic | 35 |
| New drug | 34 |
| Import | 31 |
| Unspecified | 7 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 167 |
| Therapeutic biologic | 35 |
| TCM | 26 |
| Prophylactic biologic | 6 |
| In vitro diagnostic reagent | 1 |
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
23 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 7 | 3 | 23 |
| 2 | Perindopril tert-Butylamine Tablets | 2 | 1 | 5 |
| 3 | Levetiracetam Tablets | 2 | 1 | 6 |
| 4 | Procaterol Hydrochloride Oral Solution | 2 | 1 | 12 |
| 5 | Lidocaine Hydrochloride Injection | 2 | 1 | 6 |
| 6 | Dabigatran Etexilate Capsules | 2 | 1 | 2 |
| 7 | Febuxostat Tablets | 2 | 1 | 12 |
| 8 | ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name | 1 | 1 | 0 |
| 9 | Risperidone Oral Solution | 1 | 1 | 6 |
| 10 | 噻托溴铵吸入粉雾剂 · No verified English name | 1 | 1 | 2 |
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
125 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guizhou Liang Ji Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 2 | AstraZeneca AB | 7 | 3 | 0 |
| 3 | Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Zhejiang Hui Di Sen Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Roche Pharma (Schweiz) Ltd. | 6 | 1 | 0 |
| 7 | Novo Nordisk A/S | 4 | 2 | 0 |
| 8 | GlaxoSmithKline Biologicals SA | 4 | 1 | 0 |
| 9 | MINGHUI PHARMACEUTICAL PTY LTD | 4 | 1 | 0 |
| 10 | Yunnan Xian Shi Pharma Co., Ltd. romanized | 4 | 1 | 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
71 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/06Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2101065 | F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd. |
| 2021/07/06Import · Class 1 | AZD5305 · No verified English nameJXHL2101120 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2021/07/06Import · Class 1 | AZD5305 · No verified English nameJXHL2101119 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2021/07/06Import · Class 1 | AZD5305 · No verified English nameJXHL2101118 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2021/07/06Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2101117 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/07/06Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2101399 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2021/07/06Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2101398 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2021/07/06New drug · Class 1.2 | 广金钱草总黄酮提取物 · No verified English nameCXZS2101004 | Wuhan Guang Gu Ren Fu Biopharmaceuticals Co., Ltd. romanized; Wuhan Kang Le Pharma Co., Ltd. romanized |
| 2021/07/06New drug · Class 1 | JWCAR129(靶向BCMA嵌合抗原受体T细胞) · No verified English nameCXSL2101172 | Shanghai Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized |
| 2021/07/06New drug · Class 1 | CMS203片 · No verified English nameCXHL2101265 | Name not romanized |
| 2021/07/06New drug · Class 1 | CMS203片 · No verified English nameCXHL2101264 | Name not romanized |
| 2021/07/06New drug · Class 1 | AL8326片 · No verified English nameCXHL2101263 | Nanjing Ai De Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/05Import · Class 1 | Parsaclisib片 · No verified English nameJXHL2101116 | Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd |
| 2021/07/05Import · Class 1 | Parsaclisib片 · No verified English nameJXHL2101115 | Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd |
| 2021/07/05Import · Class 1 | Parsaclisib片 · No verified English nameJXHL2101114 | Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd |
| 2021/07/05Import · Class 1 | MH004乳膏 · No verified English nameJXHL2101113 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2021/07/05Import · Class 1 | MH004乳膏 · No verified English nameJXHL2101112 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2021/07/05Import · Class 1 | MH004乳膏 · No verified English nameJXHL2101111 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2021/07/05Import · Class 1 | MH004乳膏 · No verified English nameJXHL2101110 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2021/07/05Import · Class 1 | Belzutifan片 · No verified English nameJXHL2101109 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd. |
| 2021/07/05Generic · Class 3 | Mesalamine extended release capsulesCYHS2101385 | Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2021/07/05Generic · Class 3 | Pregabalin Extended release TabletsCYHL2101017 | Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized |
| 2021/07/05New drug · Class 1.1 | 脑脉通颗粒 · No verified English nameCXZL2101016 | Guangdong Yao Ke University romanized |
| 2021/07/05New drug · Class 1 | 普特利单抗注射液 · No verified English nameCXSS2101008 | Le Pu Bio Technology Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | 注射用QLF31907 · No verified English nameCXSL2101171 | Qilu Pharmaceutical Co., Ltd. |
| 2021/07/05New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSL2101170 | Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | 注射用BJ-005 · No verified English nameCXSL2101168 | Bo Ji Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | HS-10241片 · No verified English nameCXHL2101262 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/07/05New drug · Class 1 | HS-10241片 · No verified English nameCXHL2101261 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/07/05New drug · Class 2.4 | 甲磺酸阿美替尼片 · No verified English nameCXHL2101260 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
41 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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